Thursday, August 31, 2023
Altasciences has announced the successful completion of a Phase I trial evaluating Ischemix, Inc.'s novel cytoprotective drug candidate, CMX-2043, intended for the treatment of acute traumatic brain injury (TBI). The trial took place at Altasciences' clinical facility in Montréal and aimed to assess the drug's safety, tolerability, and pharmacokinetics in a group of 80 healthy participants. The trial was conducted in a two-part, double-blind, placebo-controlled format.
In the initial segment, 40 male and female participants received single ascending doses (SAD) of CMX-2043 through brief intravenous infusion. Following this, another 40 participants, both male and female, were randomized to receive multiple ascending doses (MAD) of the drug over a period of five days. The trial's results revealed a well-defined pharmacokinetic profile, indicating dose proportionality within the studied ranges.
Dr. Jerry O. Stern, Chief Medical Officer for Ischemix, noted that the Phase I trial demonstrated CMX-2043's potential for a favorable safety profile across a wide range of intravenous doses. The trial reported no serious adverse events, with all treatment-related adverse events being mild and self-limiting. The Principal Investigator observed that few adverse events were related to the drug itself.
Traumatic brain injury lacks approved therapies specific to its treatment. In the United States alone, TBI is linked to 60,000 annual deaths and 80,000 cases of permanent disability.
Dr. Gaetano Morelli, Chief Medical Officer and Principal Investigator for Altasciences, expressed satisfaction with the study's results. As the Principal Investigator, he described witnessing the impact of TBI on individuals' lives and expressed hope for the potential positive impact of the CMX-2043 treatment on TBI patients' quality of life.
Marie-Hélène Raigneau, Co-chief Operating Officer, emphasized Altasciences' commitment to supporting companies like Ischemix in expediting drug development while maintaining quality and safety standards.
Ischemix anticipates completing the necessary work for a Phase II trial of CMX-2043 for acute TBI by the close of 2023. Additionally, the company plans to request a pre-IND (Investigational New Drug) meeting with the FDA in early Q1 2024.