(RTTNews) - Oric Pharmaceuticals (ORIC), a clinical-stage biopharmaceutical company, reported new dose-optimisation results for its Rinzimetostat or ORIC-944 from the Phase Ib Study, and outlined plans to begin its first phase III registrational study in metastatic castration-resistant prostate cancer (mCRPC).
Rinzimetostat and Phase Ib Study
Rinzimetostat (ORIC-944) is an an allosteric inhibitor being developed for prostate cancer.
Phase 1b trial evaluated once daily Rinzimetostat in combination with Darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) who were previously treated with abiraterone acetate (Abiraterone).
Key Findings Rinzimetostat 400 mg once daily was selected as recommended Phase 3 dose in combination with Darolutamide for Himalayas-1 global Phase 3 registrational trial in post-abiraterone mCRPC.
At a median follow-up of approximately 5 months, landmark 5-month radiographic progression-free survival (rPFS)was 84%, consistent with that of the competitor PRC2 inhibitor and substantially better than standard-of-care therapies in mCRPC, according to the firm.
Also, the firm noted a highly differentiated and potentially safe profile, with significantly lower frequency and severity of adverse events, nearly all Grade 1 or 2, and far fewer treatment modifications than competitor regimens.
Upcoming milestones
The company expects to initiate the Phase 3 registrational trial dubbed Himalayas-1 in mCRPC patients who have previously received abiraterone in the first half of 2026.
This proposed trial will enrol approximately 600 patients from over 250 sites in over 20 countries, randomised 1:1 to receive the RP3D of 400 mg QD Rinzimetostat in combination with Darolutamide versus the physician's choice of an AR inhibitor or chemotherapy.
Rinzimetostat 400 mg QD plus Darolutamide is currently being evaluated in a food effect cohort.
The company is also evaluating additional prostate cancer populations for future potential Phase 3 trials in mCRPC and metastatic castration-Sensitive prostate cancer (mCSPC).
Wedbush Analyst Comments
Wedbush analyst David Nierengarten reiterated an Outperform Rating on Oric Pharma but lowers the price target to $17 from $20.
Regarding Rinzimetostat, the analysts said, "Rinzi Delivers rPFS Parity without the Tox", "We see potential for incremental efficacy upside in the planned Phase 3 given earlier-line enrollment relative to the Phase 1b population, with topline data possible in late 2027/ early 2028." and "ORIC plans to provide a program update in second half of 2026, and we would be buyers ahead of this catalyst".
He also added that these efficacy outcomes were achieved with a better safety profile than that of Mevrometostat, which they believe will be sufficient to drive physician preference if replicated in a Phase 3 trial.
The company ended 2025 with $392.3 million in cash equivalents and expects its cash and investments to fund the current operating plan into the second quarter of 2028, with runway extending beyond the initial Phase 3 readout plans.
ORIC has traded between $3.89 and $14.93 in the last year. The stock closed Tuesday's trade at $12.67.
ORIC is currently trading at $9.06 down 28.64%.
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