Pathos AI Begins Phase 1b/2a Trial of CBP/p300 Inhibitor Pocenbrodib

Pathos AI, a biotechnology firm specializing in drug development through artificial intelligence, has begun dosing the first patient in a Phase 1b/2a clinical trial involving its novel drug, pocenbrodib. This trial focuses on evaluating the effectiveness of pocenbrodib, both alone and in combination with abiraterone acetate, olaparib, or 177Lu-PSMA-617, in patients suffering from metastatic castration-resistant prostate cancer (mCRPC). This drug marks Pathos' initial clinical-stage entry in its development pipeline and has shown notable efficacy in prostate cancer models resistant to treatment, bolstered by a biomarker strategy that highlights patients most likely to benefit.

Dr. Jens Renstrup, Chief Medical Officer at Pathos AI, emphasized the potential of pocenbrodib as a promising CBP/p300 inhibitor. He highlighted the drug's capacity to target and disrupt resistance mechanisms associated with androgen receptor-targeted therapies, addressing a significant unmet need for patients battling advanced prostate cancer. The company's PathOS™ platform facilitates patient selection for treatment by aligning multiomic data with real-world outcomes to pinpoint specific molecular signatures. This approach aims to enhance therapeutic success in diseases where resistance often limits treatment options. The ongoing study builds on positive data from the COURAGE study, reinforcing confidence in pocenbrodib’s ability to improve outcomes for mCRPC patients.

The P300-02-001 study is structured as a multicenter, open-label, dose-finding trial intended to verify the safety and effectiveness of pocenbrodib, whether administered alone or alongside other treatments. A total of 203 patients, all of whom have already undergone anti-androgen therapy, are expected to enroll. This trial focuses on assessing the safety profile, objective response rate, and PSA decline associated with pocenbrodib, while also establishing a preliminary recommended Phase 2 dose in combination therapies.

Pocenbrodib is an oral small molecule inhibitor targeting CREBBP/EP300 proteins, which play roles in gene activation that promote cancer cell growth. By inhibiting these proteins, pocenbrodib affects the expression of crucial cancer drivers, including the androgen receptor and its variants. This mechanism of action renders pocenbrodib significant not only for advanced prostate cancer treatment but also potentially applicable to other cancer types, whether used alone or in combination with different therapies.

Pathos AI is a clinical-stage biotechnology company leveraging AI to revolutionize drug development. The company uses AI-driven computational techniques alongside real-world data and biological models to optimize patient selection strategies in clinical trials. Pathos has garnered substantial investment, over $100 million, to expand its AI capabilities and expedite the delivery of targeted treatments to patients. For more information on Pathos AI and its initiatives, visit their website.