Essa Pharma Soars on Clinical Update for Prostate Cancer Treatment
Clinical stage pharmaceutical company, Essa Pharma (Nasdaq: EPIX), has presented updated dose escalation data from its Phase 1/2 study evaluating masofaniten in combination with enzalutamide for the treatment of prostate cancer at the 2024 ASCO Genitourinary Cancers Symposium. The company’s share price has been trending upwards since October 2023.
David Parkinson, MD, President and CEO of ESSA, commented, “The maturing data from the Phase 1 dose escalation study evaluating masofaniten in combination with enzalutamide continue to demonstrate that the combination is well tolerated, accompanied by deep and durable reductions in circulating prostate-specific antigen (“PSA”) levels.
“While the data are still immature, the durability of the PSA responses is encouraging with a median time to PSA progression currently at 16.6 months. The Phase 2 dose expansion head-to-head portion of the study is underway and is designed to evaluate the proportion of patients with a PSA decline on combination therapy compared to single agent enzalutamide. We look forward to evaluating the potential long-term benefits of masofaniten in patients with metastatic castration-resistant prostate cancer and to providing future updates.”
Highlights
Masofaniten’s unique mechanism of action disrupts the androgen receptor (AR) signaling pathway, the primary pathway that drives prostate cancer growth, by selectively binding to the N-terminal domain (NTD), a region of the AR that is not currently targeted by other therapies.
Masofaniten is currently being studied in an open-label, randomized Phase 2 clinical trial in combination with enzalutamide in patients with metastatic castration-resistant prostate cancer.
In patients evaluable for safety (n=18), masofaniten combined with enzalutamide, continues to be well-tolerated at the dose levels tested through 25 cycles of dosing in some patients.
In the patients evaluable for efficacy (n=16), rapid, deep and durable reductions in PSA were observed, regardless of previous chemotherapy status, including in patients who received lower than the full dose of enzalutamide (120 mg).
The FDA has granted Fast Track designation to masofaniten for the treatment of adult male patients with mCRPC resistant to standard-of-care treatment.
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of patients with prostate cancer. For more information, please visit www.essapharma.com, and follow us on Twitter and LinkedIn.
