Pipeline Therapeutics Reports Positive Phase 1 Clinical Results for PIPE-307, a Neuroregenerative Therapeutic for the Treatment of Multiple Sclerosis
Excerpt from the Press Release:
SAN DIEGO–(BUSINESS WIRE)–Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today reported positive clinical data from its recently completed Phase 1 clinical trial evaluating the safety and tolerability of PIPE-307 in healthy volunteers. PIPE-307, the company’s lead program for myelin restoration, is an oral, highly selective antagonist of the muscarinic M1 receptor that is being developed for the treatment of multiple sclerosis (MS). Currently, there are no approved medicines that support myelin restoration, which represents a significant unmet medical need in the treatment of MS.
The Phase 1 clinical results reported today comprised multiple dose cohorts of PIPE-307 in a total of 70 healthy volunteer subjects. PIPE-307 demonstrated linear pharmacokinetic (PK) data consistent with preclinical modeling and was generally well tolerated across all dose cohorts. Importantly, analysis of a battery of neuropsychological measures, including tests involving psychomotor, attention, learning, and executive function, were administered in the Phase 1 study and showed no significant PK or dose related effects on cognitive function.
“We believe that PIPE-307, as a first-in-class myelin restoration therapeutic, represents a differentiated and clinically-validated approach for the treatment of MS. The results of the single- and multiple-ascending dose cohorts from the completed Phase 1 study demonstrate a favorable safety and PK profile, and we are pleased to have met our primary and secondary endpoints in this study,” said Stephen Huhn, M.D., Chief Medical Officer and Senior Vice President of Clinical Development of Pipeline. “These encouraging Phase 1 results give us great confidence to advance PIPE-307 into clinical studies with MS patients as soon as possible.”
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