Cullgen Inc., the company slated to merge with Pulmatrix, announced it has commenced dosing in human subjects for its potential first-in-class, oral pan-TRK protein degrader, CG001419. This marks the initiation of a Phase 1 clinical trial to evaluate the compound for the treatment of acute and chronic pain. The program aims to address unmet medical needs in pain management with a non-opioid, non-NSAID analgesic.
The initiation of this trial follows Cullgen's recent receipt of HREC (Australia) approval to begin enrolling patients. The study will assess the safety and pharmacokinetic characteristics of CG001419 in healthy volunteers. Cullgen anticipates enrolling the first patient in early 2025, demonstrating concrete progress in its clinical development pipeline.
CG001419 is also being studied in a separate clinical trial for solid tumors, with ten patients dosed to date showing no observed dose-limiting toxicity or serious adverse events. This expansion into a second therapeutic area for its lead protein degrader highlights the breadth of Cullgen's uSMITE™ platform and its potential to advance multiple programs into clinical development, which will be central to the combined company's future.
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