First Patient Receives Gedatolisib in Phase 1b/2 mCRPC Trial

Celcuity, a biotech firm, has initiated a Phase 1b/2 clinical trial to test the efficacy of gedatolisib combined with Nubeqa, a medication used for prostate cancer treatment. Gedatolisib is a dual inhibitor targeting Class 1 PI3K isoforms and mTORC1/2, and is being studied for its potential in treating metastatic castration-resistant prostate cancer (mCRPC). The trial, designated as CELC-G-201, aims to enroll 54 participants who have seen their cancer progress after treatment with an androgen receptor inhibitor. The study will assess the safety and efficacy of gedatolisib in combination with darolutamide, the active ingredient in Nubeqa.

The collaboration with Bayer AG ensures the supply of Nubeqa for the trial, highlighting the strategic partnership between the two companies. Celcuity's Chief Medical Officer, Igor Gorbatchevsky, expressed enthusiasm for the trial, emphasizing the significant need for new therapeutic options for mCRPC patients. Karim Fizazi, a key investigator in the study, underscored the importance of exploring the combination of PAM inhibitors with next-generation androgen receptor inhibitors, given the limited treatment options for mCRPC patients who have developed resistance to current therapies.

The Phase 1b segment of the trial will focus on the safety and tolerability of the combined treatment, as well as determining the optimal dose for gedatolisib. The Phase 2 segment will measure radiographic progression-free survival at six months for patients treated with the recommended Phase 2 dose. Celcuity's lead candidate, gedatolisib, is distinguished by its mechanism of action and pharmacokinetic properties, setting it apart from other therapies targeting PI3K or mTOR.

Celcuity is also conducting a Phase 3 clinical trial, VIKTORIA-1, which evaluates gedatolisib in combination with other treatments for advanced breast cancer. Additionally, the company's CELsignia diagnostic platform is designed to analyze live tumor cells to identify patients who may benefit from targeted therapies. Headquartered in Minneapolis, Celcuity is committed to advancing targeted oncology treatments.