LAVAL, Québec–(BUSINESS WIRE)– Altasciences is pleased to have completed a Phase I trial on Ischemix, Inc.’s novel, proprietary cytoprotective drug candidate, CMX-2043, for the treatment of acute TBI. The trial was performed at Altasciences’ clinical facility in Montréal.
The Phase I trial was performed to evaluate safety, tolerability, and pharmacokinetics in a group of 80 healthy participants in a two-part, double-blind, placebo-controlled study. Single ascending doses (SAD) of CMX-2043 were administered by brief intravenous infusion to 40 male and female participants. Once completed, an additional 40 male and female participants were randomized and received multiple ascending doses (MAD) in the same manner, over five days. The results of the trial showed a well-characterized pharmacokinetic profile, demonstrating dose proportionality over the ranges studied.
“This Phase I trial demonstrates that CMX-2043 has the potential for an excellent safety profile when given intravenously over a wide range of doses,” explained Jerry O. Stern, MD, Chief Medical Officer for Ischemix. “There were no serious adverse events, and all treatment-emergent adverse events were mild and self-limiting. Importantly, the Principal Investigator determined that few adverse events were drug-related.”
There are no TBI-specific therapies approved for the treatment of patients suffering brain injury, yet it is estimated that in the U.S., TBI is responsible for 60,000 deaths per year, and the cause of 80,000 cases of permanent disability.
“It was a pleasure collaborating as the Principal Investigator on this clinical study. We are extremely pleased with the outcome of the CMX-2043 Phase I trial. Having personally witnessed first-hand the outcome that TBI can have on the lives of many people, we hope that the work we are doing with Ischemix will continue to progress. If successful, this treatment could have a tremendous positive impact on the quality of life for TBI patients. That is incredibly rewarding,” stated Dr. Gaetano Morelli, MD, Chief Medical Officer and Principal Investigator for Altasciences. “We wish the team at Ischemix continued success on the next Phase of clinical research.”
Additionally, Co-chief Operating Officer, Marie-Hélène Raigneau, said of the study: “Our goal at Altasciences is to help companies like Ischemix expedite the drug development process without compromising on quality or safety. We are proud to support Ischemix in advancing this vital new therapy.”
Ischemix expects to complete all of the work required for a Phase II trial of CMX-2043 in acute TBI by the end of 2023, and plans to request a pre-IND meeting with FDA for early Q1 2024.
Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences’ integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster. To learn more about Altasciences, visit altasciences.com.
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