Cullgen Inc. has commenced dosing in a Phase 1 clinical trial of CG001419, marking a significant advancement in the development of novel pain treatments. This first-in-class oral pan-TRK protein degrader represents a potential breakthrough in pain management, offering an alternative to traditional opioid and NSAID therapies.
Novel Mechanism of Action for Pain Management
CG001419 employs an innovative approach to pain treatment through selective degradation of both mutant and wild-type TRK proteins. This mechanism positions the drug as a pioneering member of a new class of pain signal inhibitors, specifically designed to address the critical need for effective analgesics without the addiction risks associated with current pain medications.
Clinical Trial Design and Objectives
The Phase 1 study (NCT06636500), which received ethics committee approval in Australia, is structured as a single-center, randomized, placebo-controlled, double-blind trial. The study encompasses both single-ascending-dose/food-effect and multiple-ascending-dose components, focusing on oral administration of CG001419. Primary objectives include evaluation of safety, tolerability, and pharmacokinetic characteristics in healthy volunteers.
"We are pleased to be ushering our lead candidate, CG001419, into a second clinical trial as planned. This protein degrader program is now in clinical testing in two different indications," stated Dr. Ying Luo, Chairman and CEO of Cullgen.
Technology Platform and Corporate Strategy
The development of CG001419 stems from Cullgen's proprietary uSMITE™ (ubiquitin-mediated, small molecule-induced target elimination) platform technology. This platform represents a significant advancement in targeted protein degradation, enabling the company to develop highly selective and bioavailable compounds.
"Cullgen has successfully generated a portfolio of multiple, highly active, selective, and bioavailable targeted protein degrader compounds," Dr. Luo added, emphasizing the company's broader mission to lead in next-generation targeted protein degrader development.
Corporate Development
In parallel with this clinical advancement, Cullgen is pursuing strategic growth through a merger agreement with Pulmatrix, Inc. (Nasdaq: PULM), announced on November 13, 2024. Upon completion of the merger, the combined entity will operate under the Cullgen name and maintain headquarters in San Diego, CA, with plans to trade on The Nasdaq Capital Market.
