LA JOLLA, Calif., Oct. 17, 2019 /PRNewswire/ -- Bird Rock Bio, Inc., a clinical stage biopharmaceutical company, announced today the successful completion of their phase 1b study of nimacimab, also known as RYI-018, and the planned submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 2b study in diabetic kidney disease (DKD) in Q1 2020. Nimacimab is a first-in-class negative-allosteric modulating antibody agonist to the cannabinoid 1 (CB1) receptor.
"Preclinical studies and human expression data suggest that CB1 antagonism may improve metabolic, inflammatory, and fibrotic processes that are implicated in the progression of diabetic kidney disease," said Alan Glicklich, M.D. the Company's Chief Medical Officer. "Nimacimab has great potential to provide a new treatment option in this indication."
After fulfilling the primary objectives of the nimacimab phase 1b study, the Company is exploring DKD as well as several other indications. The safety and tolerability assessments from the completed phase 1b study demonstrated no serious adverse events, no early terminations due to treatment emergent adverse events, and no adverse events of concern occurring in a dose-dependent manner. The pharmacokinetic assessment showed a half-life of approximately three weeks, potentially allowing for monthly dosing. Encouraging trends were observed in exploratory biomarkers after the three-week dosing period.
The Company has also successfully completed a toxicology study enabling long-term dosing in future clinical trials and a bioavailability study utilizing subcutaneous dosing in healthy volunteers. This will enable use of the subcutaneous formulation in the planned phase 2b study. Phase 2 drug manufacturing has been completed at a 1,000-liter scale, including an engineering run into pre-filled syringes.
"With positive results from our phase 1 study, the Company is prepared to pursue phase 2b studies in multiple indications," said Paul Grayson, President and CEO of Bird Rock Bio. "Over the past several years, scientific studies continue to implicate the CB1 pathway in several mechanisms leading to renal disease. With the completion of a 26-week toxicology study and anticipated fill of our drug product into approximately 5,000 pre-filled syringes, the program is ready to move forward in clinical development."
Discovered internally using Bird Rock Bio's proprietary iCAPS platform, nimacimab is the first and only known clinical stage negative-allosteric modulating antibody to the CB1 receptor in clinical trials. Nimacimab is a multi-modal therapeutic candidate with anti-fibrotic, anti-inflammatory, and beneficial metabolic mechanisms of action. This provides for the opportunity for nimacimab to have significant potential across a broad range of fibrotic and metabolic diseases including large unmet medical conditions such as diabetic nephropathy, NASH, and diabetic gastroparesis.
Bird Rock Bio's iCAPS platform, the leading GPCR allosteric antibody drug discovery platform, can isolate and present functional GPCRs in the correct confirmation to identify selective monoclonal antibody allosteric modulators. GPCRs (G-protein coupled receptors) are a valuable class of drug targets but have been largely unexplored in antibody discovery because of the difficulty in isolating GPCRs in the correct conformation and functional form.
About Bird Rock Bio, Inc.
Backed by leading biotechnology venture investors, Bird Rock Bio's strategy leverages biologic targets with substantial human proof of mechanism for the development of first in class molecules with strong clinical and commercial differentiation. Bird Rock Bio's scientific team is experienced with translating pioneering research into promising therapeutics with potential deep pharmacoeconomic benefits. For more, visit www.birdrockbio.com.
SOURCE Bird Rock Bio, Inc.