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Celcuity Inc. (Nasdaq: CELC) filed a Form 8-K on 30 June 2025 to furnish a press release containing preliminary clinical data for its PI3K/mTOR inhibitor gedatolisib combined with darolutamide in metastatic castration-resistant prostate cancer (mCRPC).
In the Phase 1 portion of the study, 38 patients were randomised to receive 600 mg darolutamide twice daily with either 120 mg (Arm 1) or 180 mg (Arm 2) gedatolisib administered once weekly for three weeks on/one week off. Data cut-off was 30 May 2025. Key efficacy and safety results for the pooled arms were:
- 66 % six-month radiographic progression-free survival (rPFS)
- 0 treatment-related discontinuations and no dose reductions
- No Grade 3 hyperglycaemia reported
- Grade 2-3 stomatitis observed in 4 patients (10.5 %)
The company intends to enroll up to six patients in each of three additional Phase 1 dosing arms, followed by up to 40 patients in Phase 1b to establish the recommended Phase 2 dose (RP2D). A Phase 2 expansion will bring the total treated at RP2D to approximately 30 subjects. All participants will continue to receive standard darolutamide.
Celcuity emphasised that the Item 7.01 information is being furnished, not filed, and included customary forward-looking-statement language regarding trial timelines, regulatory prospects, market opportunity, and capital requirements.
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