Dr. Pushechnikov’s presentation, titled “The Convergence of Structural Biology and Non-Human Intelligence in Brenig Therapeutics’ Early Discovery,” will highlight Brenig’s Hybrid AI Platform, developed in partnership with Expert Systems Inc and its proprietary AI-driven drug discovery technologies. This integrated approach combines physics-based structural biology with advanced machine learning to address longstanding challenges in drug discovery.

Poster Presentation Details

• Conference: Keystone Symposia Computational Advances in Drug Discovery
• Date: Friday, May 8th, 2026
• Time: 12:30 PM GMT
• Location: Park Plaza Riverbank | London, UK
• Poster number: 1012
• Title: The Convergence of Structural Biology and Non-Human Intelligence in Brenig Therapeutics’ Early Discovery
• Presenter: Alexei Pushechnikov, PhD

The presentation will showcase how Brenig’s approach enables the design of highly selective, brain-penetrant small molecules, overcoming the historical tradeoff between potency, selectivity, and central nervous system (CNS) exposure. By combining molecular dynamics–driven structural insights with large-scale AI-enabled property optimization, the platform allows for rapid iteration through a high-efficiency design–make–test cycle. Unlike traditional sequential development paradigms, Brenig applies a concurrent co-optimization strategy, enabling simultaneous refinement of potency, selectivity, safety, and CNS exposure.

This integrated approach has enabled the advancement of multiple programs from design to clinical development in approximately three years, underscoring the potential to deliver breakthrough therapies while maintaining capital efficiency.

“Brenig was founded on the belief that advancing molecules that were developed integrating rigorous physics with modern AI could fundamentally change how drugs are discovered,” said Dr. Pushechnikov. “Through our collaboration with Expert Systems, we are able to operationalize a powerful discovery engine that explores chemical space with a level of precision and efficiency that was previously not possible.”

This methodology has directly enabled the advancement of Brenig’s two clinical-stage programs:

• BT-267, a potent, selective, brain-penetrant LRRK2 inhibitor for Parkinson’s disease
• BT-409, a brain-penetrant NLRP3 inhibitor for cardiometabolic and neuroinflammatory diseases

BT-409 was originally discovered by Mwyngil Therapeutics, which utilized the same underlying platform technologies. Brenig has subsequently acquired BT-409 and advanced the program into clinical development.

Together, these programs exemplify the platform’s ability to generate compounds with optimized pharmacologic characteristics, supporting Brenig’s strategy to develop best-in-class therapies.

The company will also present data demonstrating that this hybrid approach can resolve historically intractable challenges in CNS drug development, including achieving high kinome selectivity alongside robust brain exposure. The success of BT-267, which demonstrates strong selectivity and a favorable safety profile, serves as proof-of-concept for this discovery paradigm.

“This discovery engine is not just theoretical—it has already produced clinical-stage assets with differentiated profiles,” said Megan McGill, MD, PhD, Chief Executive Officer of Brenig Therapeutics. “By partnering with Expert Systems, we’ve built a highly optimized approach to drug discovery that we believe can consistently deliver best-in-class medicines.”

About Brenig Therapeutics
Brenig Therapeutics is a clinical-stage biotechnology company developing small molecule therapies for neurodegenerative, neuroinflammatory, and cardiometabolic diseases. The company leverages an AI/ML-enabled discovery platform—developed in partnership with Expert Systems—that integrates structural biology and data-driven design to create highly selective, brain-penetrant compounds with optimized pharmacologic properties. Brenig’s lead programs include BT-267, a LRRK2 inhibitor in clinical development for Parkinson’s disease, and BT-409, a brain-penetrant NLRP3 inhibitor advancing through early clinical studies.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements regarding the initiation, timing, design, conduct, and outcomes of planned or ongoing clinical studies; the therapeutic potential, safety, and efficacy of BT-409 and BT-267; the advancement of these programs into future clinical stages; and Brenig’s development plans and strategic objectives. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in drug discovery and development, clinical trial execution and results, regulatory review and approval processes, and the availability of capital. Brenig undertakes no obligation to update any forward-looking statements contained herein, except as required by law.

Media Contact

media@brenigther.com

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The poster, titled “Phase One Study of BT-267: A Potent, Selective, Brain-penetrant, and Oral Small Molecule Inhibitor of LRRK2,” will be presented by Brenig’s Chief Medical Officer, Tien Dam, MD.

Poster Presentation Details:

• Conference: American Academy of Neurology 2026 Annual Meeting
• Date: Tuesday, April 21, 2026
• Time: 11:45 AM – 12:45 PM CDT
• Location: McCormick Place West | Hall F, Chicago
• Poster number: 17-10
• Title: Phase One Study of BT-267: A Potent, Selective, Brain-penetrant, and Oral Small Molecule Inhibitor of LRRK2
• Presenter: Tien Dam, MD

The AAN Annual Meeting is one of the largest global neurology conferences, featuring the latest advances in neurological research and therapeutics.

The poster will include updated results from Brenig’s Phase 1 study evaluating BT-267 in healthy volunteers, highlighting its pharmacokinetic profile, target engagement, and safety and tolerability.

“We are excited to share updated clinical data from our Phase 1 study of BT-267 at AAN,” said Megan McGill, MD, PhD, Chief Executive Officer of Brenig Therapeutics. “These data continue to support the potential of BT-267 as a highly brain-penetrant and selective LRRK2 inhibitor, with characteristics that may enable best-in-class positioning in Parkinson’s disease and related neurodegenerative conditions.”

Program Update: BT-409 (NLRP3 Inhibitor)
Brenig also provided an update on its second clinical program, BT-409, a selective, brain-penetrant NLRP3 inhibitor. BT-409 is currently being evaluated in a Phase 1 study with ongoing dose escalation, and the compound continues to be well-tolerated to date.

About Brenig Therapeutics
Brenig Therapeutics is a clinical-stage biotechnology company focused on developing best-in-class, brain-penetrant small molecule therapies for central nervous system diseases. The company leverages advanced computational chemistry and multiparametric optimization to design highly selective compounds with optimal CNS exposure. Brenig’s pipeline includes BT-267, a LRRK2 inhibitor in clinical development for Parkinson’s disease, and BT-409, an NLRP3 inhibitor targeting neuroinflammatory pathways across multiple CNS indications and obesity.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements regarding the initiation, timing, design, conduct, and outcomes of planned or ongoing clinical studies; the therapeutic potential, safety, and efficacy of BT-409 and BT-267; the advancement of these programs into future clinical stages; and Brenig’s development plans and strategic objectives. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in drug discovery and development, clinical trial execution and results, regulatory review and approval processes, and the availability of capital. Brenig undertakes no obligation to update any forward-looking statements contained herein, except as required by law.

Media Contact

media@brenigther.com

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International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders (AD/PD 2026)

The presentation will highlight emerging clinical data evaluating the safety, tolerability, pharmacokinetics (PK), and central nervous system (CNS) penetration of BT-267 in healthy volunteers.

Presentation Details

Title: Phase 1 Study of BT-267, a potent, selective, brain-penetrant, and oral small-molecule inhibitor of LRRK2 (ID 3219)
Presenter: Tien Dam, MD, Chief Medical Officer, Brenig Therapeutics
Symposium 6010: PD and Lewy Body Disorders: From Prevention to Novel Therapies
Date/Time: March 21, 2026 | 12:25pm CET
Location: Hall A2

“BT-267 was designed to achieve robust and sustained LRRK2 inhibition in the brain, a key driver of Parkinson’s disease biology,” said Tien Dam, MD, Chief Medical Officer of Brenig Therapeutics. “In our ongoing Phase 1 study, we observe encouraging pharmacokinetic properties, including evidence of meaningful CNS exposure, which we believe may support a best-in-class profile for the LRRK2 inhibitor class. We look forward to sharing these data at AD/PD.”

BT-267 is a potent, selective, brain-penetrant inhibitor of LRRK2, a genetically validated target implicated in Parkinson’s disease. The ongoing Phase 1 study is designed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamic effects of BT-267 in healthy volunteers.

Pipeline Update: BT-409 (NLRP3 Inhibitor Program)

Brenig also announced that it has dosed healthy volunteers in its Phase 1 clinical trial of BT-409, a brain-penetrant NLRP3 inhibitor targeting neuroinflammation. BT-409 has been well tolerated to date, with no safety signals observed thus far and the study is progressing as planned. The Company believes BT-409 has the potential to be a best-in-class compound with high brain penetration to address a broad range of neuroinflammatory conditions.

About Brenig Therapeutics

Founded in 2021 through a venture creation initiative led by Torrey Pines Investment and OrbiMed, Brenig Therapeutics secured a $65 million Series A financing in July 2024, led by NEA with participation from BioGeneration Ventures, OrbiMed, Torrey Pines, and other U.S.-based healthcare investors. Brenig is dedicated to developing innovative small-molecule therapies to address fundamental disease mechanisms and accelerate clinical translation for neurodegenerative diseases.  BT-409 was licensed from Mwyngil Therapeutics.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements regarding the initiation, timing, design, conduct, and outcomes of planned or ongoing clinical studies; the therapeutic potential, safety, and efficacy of BT-409 and BT-267; the advancement of these programs into future clinical stages; and Brenig’s development plans and strategic objectives. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in drug discovery and development, clinical trial execution and results, regulatory review and approval processes, and the availability of capital. Brenig undertakes no obligation to update any forward-looking statements contained herein, except as required by law.

Media Contact

media@brenigther.com

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BT-409: Brain-Selective NLRP3 Inhibitor Advancing to First-in-Human Evaluation

BT-409, a small-molecule NLRP3 inhibitor licensed from Mwyngil Therapeutics, was discovered and optimized using a proprietary artificial intelligence (AI)- and machine learning (ML)-enabled discovery and development platform, with a design focus on central nervous system (CNS) penetration, potency, and pharmacokinetic properties suitable for chronic neurologic indications.

The company has initiated a Phase 1 single ascending dose (SAD)/multiple ascending dose (MAD) study, with first dosing anticipated in early Q1 2026. The study is designed to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic profile of BT-409 in healthy volunteers.

Subject to successful completion of Phase 1, Brenig plans to advance BT-409 into proof-of-concept studies in Multiple Sclerosis and Parkinson’s disease, evaluating the therapeutic potential of central inflammasome inhibition in neuroinflammation and neurodegeneration, including potential interactions with pathways involved in lysosomal and neuronal homeostasis.

“BT-409 exemplifies our ability to design neuroinflammation-targeting molecules with the selectivity and pharmacology required for neurodegenerative disease,” said Megan McGill, MD, PhD, Chief Executive Officer of Brenig. “We are focused on translating this program efficiently into the clinic with the goal of delivering meaningful new treatment options for patients affected by neuroinflammatory and neurodegenerative diseases, and we look forward to exploring the potential of BT-409 across multiple neurologic indications.” 

BT-267: Continued Clinical Progress and Planned Parkinson’s Disease Studies

Brenig reports continued progress in its clinical program for BT-267, a LRRK2 inhibitor rationally designed to achieve robust CNS exposure while minimizing peripheral and systemic effects. Early clinical data demonstrate a favorable pharmacokinetic profile supporting sustained CNS exposure at levels predicted to exceed LRRK2 IC50 thresholds, with an encouraging safety and tolerability profile to date.

The company plans to initiate a Phase 1b study and commence start-up activities for a Phase 2 proof-of-concept trial of BT-267 in individuals with Parkinson’s disease in early 2026.

BT-267 has been engineered for high brain permeability, potency, and selectivity—attributes believed to be critical for disease-modifying LRRK2 inhibition in Parkinson’s disease.

“The emerging clinical profile of BT-267 supports its potential as a best-in-class LRRK2 inhibitor,” said Tien Dam, MD, Chief Medical Officer of Brenig Therapeutics. “We believe CNS-optimized LRRK2 inhibition remains one of the most compelling therapeutic strategies in Parkinson’s disease, and we are focused on advancing BT-267 efficiently into patient studies.”

About Brenig Therapeutics

Founded in 2021 through a venture creation initiative led by Torrey Pines Investment and OrbiMed, Brenig Therapeutics secured a $65 million Series A financing in July 2024, led by NEA with participation from BioGeneration Ventures, OrbiMed, Torrey Pines, and other U.S.-based healthcare investors. Brenig is dedicated to developing innovative small-molecule therapies to address fundamental disease mechanisms and accelerate clinical translation for neurodegenerative diseases.  BT-409 was licensed from Mwyngil Therapeutics. 

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements regarding the initiation, timing, design, conduct, and outcomes of planned or ongoing clinical studies; the therapeutic potential, safety, and efficacy of BT-409 and BT-267; the advancement of these programs into future clinical stages; and Brenig’s development plans and strategic objectives. Forward-looking statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks and uncertainties include, among others, uncertainties inherent in drug discovery and development, clinical trial execution and results, regulatory review and approval processes, and the availability of capital. Brenig undertakes no obligation to update any forward-looking statements contained herein, except as required by law.

Media Contact

media@brenigther.com

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“I am delighted to welcome Dr. Megan McGill to the Board of Directors and executive team at Brenig,” said Iain Dukes, M.A., D.Phil., Chairman of the Board of Brenig and a venture partner at OrbiMed. “Megan is an exceptional leader with experience in drug development that will help Brenig progress our potential best-in-class treatments for Parkinson’s disease into the next stage of development and expand our pipeline for neurological disorders.”

Dr. McGill brings over ten years of experience spanning clinical medicine, drug discovery, translational neuroscience, and biotech company building. Prior to joining Brenig, she held leadership roles at Epitor Therapeutics, Regel Therapeutics and HitchBio as CEO as well as BridgeBio and Regenxbio in business development and strategy roles. She earned M.D. and Ph.D. degrees in neuroimaging and MRI physics from New York University School of Medicine, and residency training at Memorial Sloan Kettering Cancer Center and NYU Radiology. She also worked as a management consultant at McKinsey & Co. These experiences position Dr. McGill to help Brenig progress towards clinical success and growth. 

“Neurologic disorders touch millions and remain a profound area of unmet need,” said Dr. McGill. “I’m honored to join Brenig Therapeutics’ world-class team to accelerate a pipeline that translates promising biology into therapies that can meaningfully improve patients’ lives.”

Brenig also announced that David L. Lucchino has stepped down from the company and wished him well in his next endeavor.

Founded in 2021 through the venture creation incubator run by Torrey Pines Investment and OrbiMed, Brenig secured a $65 million Series A financing in July 2024. That round was led by NEA with participation from BioGeneration Ventures, OrbiMed, Torrey Pines, and an additional US-based healthcare investor. 

Brenig is currently advancing BT-267, a best-in-class LRRK2 inhibitor with the potential to be a disease-modifying treatment for both idiopathic and LRRK2-associated Parkinson’s disease. Proof-of-concept studies in patients with idiopathic Parkinson’s disease are expected to begin in the second half of 2026. In addition, the company is advancing BT-409, a brain penetrant NLRP3 inhibitor through IND-enabling studies as it prepares to initiate clinical studies in healthy volunteers and ultimately Parkinson’s disease patients.

About BT-267

BT-267 is a small-molecule inhibitor targeting leucine-rich repeat kinase 2 (LRRK2), a protein implicated in Parkinson’s disease. BT-267 was designed and optimized for selectivity and to maximize brain permeability and distribution, thereby aiming to limit peripheral on- and off-target adverse effects. BT-267 has demonstrated promising preclinical results, including high brain penetration, minimal peripheral exposure, and a favorable safety profile. In November 2024, Brenig initiated a first-in-human clinical trial to assess BT-267’s safety and tolerability in healthy volunteers, with plans to conduct proof-of-concept studies in patients with Parkinson’s disease. Brenig anticipates topline data from the Phase 1a SAD and MAD studies, being conducted in Australia, by the end of second quarter 2026, with initiation of a proof of concept study in patients with Parkinson’s disease by the end of 2026. 

About BT-409

BT-409 is a novel potentially best in class small-molecule NLRP3 inhibitor designed to efficiently cross the blood-brain barrier, targeting a critical unmet need in neuroinflammation and neurodegenerative diseases. Preclinical studies demonstrated its potential to suppress NLRP3-driven neuroinflammation implicated in: Parkinson’s disease by slowing neurodegeneration; Alzheimer’s disease by modulating amyloid- and tau-associated inflammation; Multiple sclerosis by reducing demyelination and neuronal damage; Progressive Supranuclear Palsy (PSP) by mitigating tau-related neurodegeneration. Under the agreement, Brenig Therapeutics will advance BT-409 through clinical development and commercialization, with Phase 1a/b trials in healthy volunteers and idiopathic Parkinson’s disease patients planned for Q4 2025.

About Brenig Therapeutics

Founded in 2021 and based in Somerville, MA, Brenig Therapeutics is a biotechnology company committed to pioneering innovative small-molecule therapies for neurodegenerative diseases. Through advanced science and leading AI and machine learning discovery models, Brenig aims to deliver transformative solutions to address the root causes of debilitating neurologic conditions. 

Media Contact:

media@brenigther.com 

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The trial began in November 2024, dosing healthy volunteers to evaluate BT-267’s safety and tolerability. Following this initial assessment, proof-of-concept studies are planned for patients with idiopathic Parkinson’s disease.

Preclinical data underscores the potential of BT-267 as the best-in-class LRRK2 inhibitor, confirming a superior safety profile, with little or no visible lung or kidney morphological changes at the highest tested doses in GLP toxicology studies and exceptional pharmacokinetics, including high cerebrospinal fluid (CSF) to plasma unbound ratio.

BT-267 benefits from cutting-edge computer-aided drug design, AI/ML computational pharmacology, biomarker models, and the structural biology expertise of its partner Expert Systems Accelerator. Brenig’s advanced approach to predictive biomarkers may help position BT-267 candidate as a promising disease-modifying therapy for Parkinson’s, including idiopathic cases that lack known genetic drivers.

About Brenig Therapeutics
Brenig Therapeutics is a biotechnology company committed to pioneering innovative therapies for neurodegenerative diseases. Through advanced science and a focus on patient needs, Brenig aims to deliver transformative solutions to address the root causes of these debilitating conditions.

For media inquiries, please contact:

Dana Hilt, MD PhD

Chief Medical Officer

Brenig Therapeutics

dhilt@brenigther.com

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• Proceeds support advancing leading pre-clinical development candidate BT-267, a best-in-class leucine-rich repeat kinase 2 (LRRK2) inhibitor, into human clinical trials for the treatment of idiopathic and LRRK2-mutuated Parkinson’s disease
• Additional assets targeting Parkinson’s disease will also be evaluated and potentially added to fuel the neurology-focused pipeline

Brenig Therapeutics Inc. (Brenig), a pioneering neurology-focused drug development company utilizing an AI/ML-based discovery platform, today announced the closing of a $65 million Series A financing. The financing was led by New Enterprise Associates (NEA) with support from an additional US-based healthcare investor as well as existing investors: OrbiMed, Torrey Pines Investments and BioGeneration Ventures. In connection with the financing, Ed Mathers, Partner at NEA, will join the Board of Directors.

“With the financing, we advance our goal of addressing the needs of Parkinson’s disease patients with our differentiated drugs,” commented Iain Dukes MA DPhil, Chairman of Brenig.

“The Brenig team has made remarkable progress since inception,” said Ed Mathers. “We believe their approach could lead to best-in-class therapeutics for the treatment of Parkinson’s disease. NEA is thrilled to partner with Brenig through its next phase of growth”.

Brenig plans to use the proceeds from this financing to advance BT-267 through healthy volunteer studies and into proof-of-concept studies in idiopathic Parkinson’s disease patients. In addition, the company will explore advancing additional best-in-class approaches for Parkinson’s disease.

About BT-267

BT-267, a small molecule LRKK2 inhibitor, was designed to have a best-in-class PK profile enabling high and sustained brain exposure and minimal peripheral exposure, thereby ensuring superior efficacy while minimizing on-target, off-tissue toxicity. The molecule exhibits exquisite kinome selectivity, avoiding off-target effects. A clean safety profile has been confirmed through ongoing GLP studies.

About Brenig Therapeutics

Brenig is a small molecule drug development company that utilizes an AI/ML approach via a partnership with Expert Systems Inc., a drug accelerator that has spawned multiple best-in-class clinical candidates across multiple therapeutic areas.

About NEA

New Enterprise Associates, Inc. (NEA) is a global venture capital firm focused on helping entrepreneurs build transformational businesses across multiple stages, sectors, and geographies. Founded in 1977, NEA has over $25 billion in assets under management as of December 31, 2023, and invests in technology and healthcare companies at all stages in a company’s lifecycle, from seed stage through IPO. The firm’s long track record of investing includes more than 270 portfolio company IPOs and more than 450 mergers and acquisitions. For more information, please visit www.nea.com.

Media Contact:

Iain Dukes, PhD
Executive Chairman
dukesi@orbimed.com

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Brenig’s innovative approach to the rationally designed LRRK2 inhibitor (BT-0267) marks a significant stride in the company’s mission to combat neurodegenerative diseases. LRRK2, a key protein implicated in Parkinson’s disease (PD), has been a challenging therapeutic target. Brenig’s cutting-edge research has culminated in the development of a candidate with a highly efficient blood-brain barrier penetration, minimal peripheral exposure, as well as a superior overall safety profile.

Current data highlights the superior safety profile of LRRK2 Inhibitor BT-0267 with an exceptional CSF to plasma ratio, in vivo efficacy of BT-0267 in brain and no visible lung and kidney morphological changes compared to other LRRK2 inhibitor candidates. BT-0267 will be entering human clinical trials by the end of 2024.

Brenig’s breakthrough efforts in developing the best-in-class LRRK2 inhibitor for the disease modifying treatment of PD population, including idiopathic PD (iPD) cases, have been supported by the cutting-edge computer-aided drug design and structural biology expertise of Expert Systems Accelerator.

About Brenig Therapeutics

Brenig Therapeutics is a European science-based venture dedicated to pioneering breakthrough treatments for neurodegenerative diseases. With a focus on developing innovative therapies, Brenig is committed to advancing the field of neurology through cutting-edge research and strategic partnerships.

The post Brenig Therapeutics Presented New Data for the Best-in-Class LRRK2 Inhibitor Targeting Parkinson’s Disease at the ACS Spring 2024 Conference appeared first on Brenig Therapeutics.

LRRK2, recognized as a crucial drug target in Parkinson’s disease, plays a major role in the pathogenesis of the condition. Inhibiting LRRK2 activity has emerged as a promising disease-modifying therapeutic strategy, and several drug candidates have achieved clinical status.

The BT-0267 candidate has an efficient blood-brain barrier penetration while minimized peripheral exposure as well as has a superior overall safety profile. The presented data highlighted the in vivo efficacy of BT-0267 in brain and no visible lung and kidney morphological changes compared to other LRRK2 inhibitor candidates. Additionally, BT-0267 has an outstanding cerebrospinal fluid (CSF)/unbound plasma ratio in non-human primates, exhibits a remarkable 1000x selectivity against other kinases, and >500x selectivity against other targets from the safety panel, providing indicators of its best-in-class safety profile.

Dr. Alexei Pushechnikov, Head of Chemistry and CTO at Brenig Therapeutics, remarked, “Achieving an outstanding CSF/plasma ratio for BT-0267 is in line with our rational design strategy to reduce potential lung and kidney toxicity effects in our LRRK2 inhibition program.”

About Brenig Therapeutics

Brenig Therapeutics, a portfolio company of OrbiMed Advisors, Torrey Pines Investments, and BioGeneration Ventures, focuses on developing innovative therapies for neurodegenerative diseases. The company’s pipeline includes BT-0267, a best-in-class LRRK2 inhibitor with a superior safety profile, currently advancing towards clinical development for Parkinson’s disease.

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