BT-267 / Brenig Therap - LARVOL DELTA

PHASE 1 STUDY OF BT-267, A POTENT, SELECTIVE, BRAIN-PENETRANT, AND ORAL SMALL MOLECULE INHIBITOR OF LRRK2 (ADPD 2026) - "BT-267 has preferential distribution in the central nervous system, with potential to maximize central exposures while minimizing peripheral exposures. These results suggest that BT-267 may provide a differentiated safety and efficacy profile, supporting continued investigation of BT-267 in individuals with PD."

P1 data • CNS Disorders • Movement Disorders • Parkinson's Disease • LRRK2 • RAB10

Brenig Therapeutics Announces Oral Presentation of Phase 1 Data for BT-267 at AD/PD 2026, and Provides Updates on BT-409, its NLRP3 Inhibitor Program (PRNewswire) - "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....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."

P1 data • Trial status • Parkinson's Disease

Phase One Study of BT-267: A Potent, Selective, Brain-penetrant, and Oral Small Molecule Inhibitor of LRRK2 (AAN 2026) - "BT-267 has preferential distribution in the central nervous system, with potential to maximize central exposures while minimizing peripheral exposures. These results suggest that BT-267 may provide a differentiated safety profile and support continued investigation of BT-267 in HA and individuals with PD."

CNS Disorders • Movement Disorders • Parkinson's Disease • LRRK2 • RAB10

BT-267: Continued Clinical Progress and Planned Parkinson's Disease Studies (PRNewswire) - "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."

Clinical data • New P1 trial • New P2 trial • Parkinson's Disease

A Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered ZE75-0267 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of ZE75-0267 in Healthy Volunteers (ANZCTR) - P1 | N=64 | Recruiting | Sponsor: Brenig Therapeutics AU Pty Ltd. (subsidiary of Brenig Therapeutics ) | Not yet recruiting ➔ Recruiting | Initiation date: Dec 2024

Enrollment open • Trial initiation date • CNS Disorders • Movement Disorders • Parkinson's Disease

GLP SAFETY AND PK/PD STUDIES FOR NOVEL ORAL HIGHLY SELECTIVE LRRK2 INHIBITOR (BT -0267) (ADPD 2025) - " BT-0267 is a potentially best in class oral, highly selective LRRK2 inhibitor with outstanding pharmacokinetics and high brain permeability... Discovered LRRK2 inhibitor with superior kinome selectivity compared to the publicly known best references. BT -0267 demonstrates outstanding in vivo PK and a high Brain(unbound)/Plasma(unbound) ratio. GLP toxicology studies confirmed broad safety and toler ability of BT -0267 to advance the drug candidate to clinic."

Clinical • PK/PD data • LRRK2

Brenig Therapeutics Announces the Initiation of First-in-Human Clinical Trial of BT-267, a Best-in-Class LRRK2 Inhibitor for Parkinson's Disease (PRNewswire) - "Brenig Therapeutics announced the initiation of the first-in-human clinical trial for BT-267, a best-in-class LRRK2 inhibitor developed as a potential disease-modifying treatment for idiopathic and LRRK2-associated Parkinson's disease...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."

New trial • CNS Disorders • Parkinson's Disease

Brenig Therapeutics Announces $65 Million Series A Financing to Advance Leading Pre-Clinical Parkinson's Disease Pipeline (PRNewswire) - "Brenig Therapeutics Inc...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....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."

Financing • CNS Disorders • Parkinson's Disease

Brenig Therapeutics Presented New Data for the Best-in-Class LRRK2 Inhibitor Targeting Parkinson's Disease at the ACS Spring 2024 Conference (PRNewswire) - "Brenig Therapeutics...presented new safety data on its LRRK2 inhibitor drug candidate at the ACS Spring 2024 Conference at the New Orleans Ernest N. Morial Convention Center, on March 17th, 2024....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."

New trial • Preclinical • CNS Disorders • Parkinson's Disease

Brenig Therapeutics Unveils Superior Safety Profile of LRRK2 Inhibitor BT-0267 with Exceptional CSF/Plasma Ratio at Future of Parkinson's Disease Conference (PRNewswire) - "Brenig Therapeutics...announces new data on its LRRK2 inhibitor drug candidate, BT-0267. The results were unveiled at the prestigious Future of Parkinson's Disease Conference....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."

Preclinical • CNS Disorders • Parkinson's Disease