CHICAGO, Mar. 20, 2025 (GLOBE NEWSWIRE) — Pathos AI, (www.pathos.com), a clinical-stage biotechnology company focused on re-engineering drug development through artificial intelligence, announced the first patient has been dosed in the Company’s Phase 1b/2a clinical trial evaluating pocenbrodib, a CBP/p300 inhibitor, alone and in combination with abiraterone acetate, olaparib or 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC), (P300-02-001, NCT06785636). Pocenbrodib is Pathos’ first clinical-stage asset in its pipeline.

“The clinical promise of pocenbrodib, our potential best-in-class CBP/p300 inhibitor, lies not only in its remarkable efficacy in resistant prostate cancer models, but also in our sophisticated biomarker strategy that identifies patients most likely to benefit,” said Dr. Jens Renstrup, Chief Medical Officer. “Our precision medicine approach allows us to target the underlying resistance mechanisms to AR-targeted therapy through CBP/p300 inhibition, addressing a significant area of high unmet need for patients with advanced prostate cancer. By integrating multiomic data tied to real-world outcomes to identify specific molecular signatures, our PathOSTM platform enables us to select the right patients for treatment, potentially improving outcomes in a disease with limited therapeutic options as resistance develops. This study builds on the previously reported data from COURAGE study (NCT04575766) in metastatic castration-resistant prostate cancer and reinforces our confidence in pocenbrodib’s potential to improve outcomes for these patients.”

Study P300-02-001 is a multicenter, open-label, dose-finding Phase 1b/2a clinical trial to confirm the safety, pharmacokinetics (PK), preliminary antitumor activity, and pharmacodynamics (PD) of pocenbrodib alone or in combination with abiraterone acetate, olaparib or 177Lu-PSMA-617, in adults with metastatic castration-resistant prostate cancer (mCRPC). The study is expected to enroll approximately 203 patients with mCRPC who have progressed despite prior therapy and have been treated with at least one anti-androgen therapy (enzalutamide, apalutamide, abiraterone acetate, or darolutamide). The primary objectives of the study are to assess the safety, objective response rate, and PSA decline of pocenbrodib alone and in combination with abiraterone acetate, olaparib or 177Lu-PSMA-617, and to define a preliminary recommended Phase 2 dose (RP2D) of pocenbrodib in combination with abiraterone acetate, olaparib or 177Lu-PSMA-617.

About Pocenbrodib

Pocenbrodib is an oral, small molecule inhibitor that has the potential to provide clinical benefit for patients with advanced prostate cancer, either alone or in combination with other treatments. Pocenbrodib works by inhibiting CREBBP/EP300 (also known as CBP/p300), which are proteins that activate genes that promote cancer cell growth and proliferation. Inhibiting these proteins impacts the expression of key cancer drivers, including the androgen receptor (AR) and its variants, making pocenbrodib relevant not only to advanced prostate cancer, but also to other cancer indications, either alone or in combination with other treatments.

About Pathos AI

Pathos is a clinical-stage biotechnology company powered by advanced AI that is re-engineering drug development by optimizing patient selection strategies in phase 2 clinical trials. Through partnerships with pharmaceutical companies, Pathos leverages AI-driven computational approaches across multimodal real-world data and patient-derived biological models to accelerate precision medicine development. Pathos has raised over $100 million to expand its AI platform and bring targeted treatments to patients faster. Additional information can be found at www.pathos.com.