ORIC Pharmaceuticals announced positive preliminary data from a Phase 1b trial of ORIC-944, a potential best-in-class PRC2 inhibitor, combined with androgen receptor (AR) inhibitors in patients with metastatic castration-resistant prostate cancer (mCRPC). The combination therapies showed promising efficacy, with a 59% PSA50 response rate and a 24% PSA90 response rate, and a favorable safety profile, primarily mild to moderate gastrointestinal side effects. The company also secured $125 million in financing, extending its cash runway into the second half of 2027.
These results are particularly encouraging for mCRPC patients, who often face limited treatment options after progressing on standard therapies. The high PSA response rates observed across different ORIC-944 dose levels and with both apalutamide and darolutamide suggest broad potential applicability. The favorable safety profile is also crucial, as it indicates the potential for long-term treatment, which is critical in managing this chronic disease. This could represent a significant advancement in mCRPC treatment, potentially offering a new, effective, and tolerable option for these patients.
The Phase 1b trial enrolled 17 patients with mCRPC who had received a median of three prior lines of therapy. Patients received once-daily ORIC-944 at 400 mg, 600 mg, or 800 mg, in combination with either once-daily apalutamide or twice-daily darolutamide. The most common treatment-related adverse event was diarrhea, occurring in 53% of patients, with only one Grade 3 event reported. No Grade 4 or 5 treatment-related adverse events were observed. The secured funding provides ORIC with the resources to complete the Phase 1b dose optimization portion and initiate a Phase 3 registrational trial in the first half of 2026.
The promising efficacy and safety data, combined with the extended financial runway, positions ORIC well to advance ORIC-944 into late-stage development. This positive momentum sets the stage for potential future regulatory filings and eventual commercialization, ultimately aiming to bring a much-needed new treatment option to mCRPC patients. Further data from the ongoing trial and the subsequent Phase 3 study will be critical in confirming the long-term efficacy and safety profile of ORIC-944.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
