Positive results announced from phase 1 trial of novel IV therapeutic for acute TBI

A Philadelphia-area contract research organization has announced completion of a phase 1 clinical trial of CMX-2043, Ischemix Inc.’s novel, proprietary cytoprotective drug candidate to treat acute traumatic brain injury.

According to a release from Altasciences, the trial, which was conducted at its facility in Montreal, assessed safety, tolerability and pharmacokinetics in 80 healthy participants (40 male, 40 female) in a two-part, double-blind, placebo-controlled study.

In the first part, single ascending doses of CMX-2043 were administered by IV infusion, then in the second, an additional 40 male and 40 female participants were randomized to receive multiple ascending doses, in the same manner, over five days.

Results showed a well-characterized pharmacokinetic profile, demonstrating dose proportionality over the ranges studied, with mild treatment-emergent adverse events, few of which could be attributed to the drug itself, per the release.

“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,” Jerry O. Stern, MD, chief medical officer for Ischemix, stated in the release.

Currently, there are no TBI-specific therapies approved for those who sustain these types of injuries. An estimated 60,000 deaths per year are attributed to TBI, and it is the cause of 80,000 cases of permanent disability in the United States, according to the release.

“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,” Gaetano Morelli, MD, chief medical officer and principal investigator for Altasciences, said in the release. “We wish the team at Ischemix continued success on the next phase of clinical research.”