IRLAB’s drug candidate pirepemat’s Phase I data published in scientific journal CPDD

June 15, 2021

IRLAB (Nasdaq Stockholm: IRLAB A) today announced that a scientific publication reporting the results from the clinical first-in-human (Phase I) study with pirepemat has been published in the journal Clinical Pharmacology in Drug Development (CPDD). Pirepemat is in development to improve balance and reduce falls in Parkinson’s disease, and has completed Phase IIa studies. A Phase IIb study to evaluate effects of pirepemat on frequency of falls in patients with Parkinson’s disease is planned to be initiated during 2021.

IRLAB (Nasdaq Stockholm: IRLAB A) today announced that a scientific publication reporting the results from the clinical first-in-human (Phase I) study with pirepemat has been published in the journal Clinical Pharmacology in Drug Development (CPDD). Pirepemat is in development to improve balance and reduce falls in Parkinson’s disease, and has completed Phase IIa studies. A Phase IIb study to evaluate effects of pirepemat on frequency of falls in patients with Parkinson’s disease is planned to be initiated during 2021.

The scientific paper describes the randomized, double-blind, placebo-controlled Phase I, first-in-human (FIH), study with pirepemat. The study evaluated the safety, tolerability, and pharmacokinetics of escalating single and multiple doses of pirepemat. It was concluded that pirepemat was safe and well-tolerated in healthy male volunteers. Pharmacokinetic analysis indicated rapid absorption and dose-linear pharmacokinetics of pirepemat upon single and repeated dosing. The pharmacokinetics of pirepemat supports three-times-daily use in patients with Parkinson’s disease.

“Publication of results from preclinical and clinical studies are an important part of drug development and is at the center of our strategy to establish our science and pipeline broadly in the industry. This is the second publication of Phase I results from our drug candidates in a short time that supports validation of our pipeline’s great potential in Parkinson’s disease,” said Susanna Waters, M.D., Ph.D, Director of Biology & Biostatistics at IRLAB.

Clinical Pharmacology in Drug Development (CPDD) is an international, peer-reviewed, online publication focused on publishing high-quality clinical pharmacology studies in drug development which are primarily, but not exclusively, performed in early development phases and in healthy subjects.

Publication: Rein‐Hedin E, Sjöberg F, Waters S, Sonesson C, Waters N, Huss F, Tedroff J. First‐in‐Human Study to Assess the Safety, Tolerability, and Pharmacokinetics of Pirepemat, a Cortical Enhancer, in Healthy Volunteers. Clinical Pharmacology in Drug Development. 2021,0 (0);1–10. https://doi.org/10.1002/cpdd.959.