Pharma Focus Europe

Pipeline Therapeutics Granted Fda Clearance to Begin Phase 1 Study of Pipe-791

Friday, June 09, 2023

Pipeline Therapeutics has received clearance from the U.S. Food and Drug Administration (FDA) to begin a Phase 1 clinical trial of their drug candidate, PIPE-791, in healthy volunteers. PIPE-791 is a small molecule antagonist of the lysophosphatidic acid 1 receptor (LPA1), which plays a crucial role in bioactive phospholipid signaling and is involved in nervous system and systemic inflammatory conditions. The drug has the potential to promote remyelination and reduce neuro-inflammation, making it particularly relevant for the treatment of multiple sclerosis (MS), a condition for which there are currently no approved therapies to prevent neuronal loss and mitigate clinical disability.

Carmine Stengone, the President and CEO of Pipeline, expressed excitement about the FDA clearance, emphasizing the company's commitment to developing precision therapies for neurological diseases. PIPE-791 represents Pipeline's second clinical program and the first one targeting both remyelination and neuro-inflammation. The company aims to evaluate the unique LPA1 inhibition approach with PIPE-791 and hopes to deliver significant benefits to individuals with MS and other neurological and systemic diseases.

Dr. Stephen Huhn, the Chief Medical Officer and Senior Vice President of Clinical Development at Pipeline, stated that the Phase 1 study will assess the safety and tolerability of PIPE-791 compared to a placebo in healthy volunteers. The dosing is expected to begin in the second half of 2023. The trial will be randomized, double-blind, and placebo-controlled, involving approximately 80 healthy volunteer subjects.

PIPE-791 is a brain-penetrant small molecule antagonist of the LPA1 receptor that has shown activity in both in vitro and in vivo models. It has been well-tolerated in studies preparing it for investigational new drug (IND) submission. PIPE-791 has demonstrated evidence of promoting oligodendrocyte differentiation, myelination, and protection against cytokine-induced oligodendrocyte cell death in in vitro studies. In preclinical in vivo models, it has shown central nervous system LPA1 receptor occupancy, increased remyelination, and inhibition of neuro-inflammation.

In summary, Pipeline Therapeutics is moving forward with its Phase 1 clinical trial for PIPE-791, a promising drug candidate with potential for remyelination and reducing neuro-inflammation in MS and other neurological conditions. The company is dedicated to advancing precision therapies and aims to bring meaningful benefits to patients with neurological diseases.

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