EPI-7386 in combination with enzalutamide was safe and well tolerated at the doses tested with clinically relevant drug exposures and profound and sustained reductions in prostate-specific antigen (“PSA”) observed in five of six patients
SOUTH SAN FRANCISCO, CA and Vancouver, Canada, October 26, 2022 /CNW/ – ESSA Pharma Inc. (“ESSA” or the “Company”) (NASDAQ: EPIX), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, announced today today the presentation of updated data from the first two cohorts of the phase 1/2 study of ESSA’s lead candidate EPI-7386 in combination with enzalutamide in patients with prostate cancer metastatic castration-resistant prostate (“mCRPC”). The data will be presented as a poster at the 2022 Prostate Cancer Foundation (“PCF”) Scientific Retreat, which will take place October 27-29, 2022 in Carlsbad, California.
In the multicenter, open-label, phase 1/2 dose-escalation study, seven second-generation antiandrogen naïve mCRPC patients were enrolled in the first two cohorts, with increasing doses of EPI-7386 and a fixed dose of 120 mg once daily (QD) of enzalutamide. The study allowed for an earlier line of chemotherapy. Pharmacokinetic results from these first two cohorts demonstrated that enzalutamide exposure was little affected by EPI-7386, while EPI-7386 exposure was reduced by co-administration with enzalutamide , but remained within the clinically relevant range, as suggested by preclinical xenograft studies. The safety of the combination was favorable with a safety profile consistent with second generation antiandrogens and no dose limiting toxicity was observed. One of the patients in the first cohort discontinued treatment after one cycle of administration due to a concomitant strong CYP3A inducing drug that reduced exposures to both EPI-7386 and enzalutamide and whose effectiveness was therefore not assessable. Anti-tumor activity in the remaining six enrolled patients demonstrated that four of these six patients achieved PSA90 after 12 weeks of treatment and five of the six patients to date achieved PSA90.
“We are encouraged by the rapid and profound PSA responses seen in the dose escalation study of EPI-7386 in combination with enzalutamide,” said David Parkinson, MD, President and CEO of ESSA. “Therapies continue to be safe and well tolerated, and pharmacokinetic results demonstrate that enzalutamide exposure was minimally affected by EPI-7386 as expected. We are currently recruiting a third dose escalation cohort as that we are optimizing the therapeutic dose of EPI-7386 in the study combination in preparation for Phase 2.”
Two additional posters will be presented at the conference highlighting updated results from the first-in-man Phase 1a dose-escalation study of EPI-7386 as monotherapy in mCRPC patients with antiandrogen failure. Current second-generation and preclinical data on ESSA’s first-in-class N-terminal Androgen Receptor Domain (“ANITAC”™) protein degradation program.
The details of the presentation are as follows:
Title: Oral EPI-7386 in Patients With Metastatic Castration-Resistant Prostate Cancer: Results from the First-in-Human Phase 1a Dose Escalation Study
Authors: Andre Lacetti, et al.
Title: Phase 1/2 Study of EPI-7386 in Combination With Enzalutamide (Enz) Versus Enz Alone in Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC): Preliminary Results of the phase 1 (P1) of the dose optimization part of the study
Authors: Andre Lacetti, et al.
Title: Advances in the development of an N-terminal domain-targeted androgen receptor degrader (ANITAC) for the treatment of prostate cancer
Authors: Nan Hyung Hong, et al.
The three posters are available on the PCF 2022 Scientific Retreat website and in the “Publications” section of the Company’s website at www.essapharma.com.
About PPE-7386
EPI-7386 is an oral, experimental and highly selective small molecule inhibitor of the N-terminal domain of the androgen receptor. EPI-7386 is currently being studied in a Phase 1 clinical trial (NCT04421222) in men with castration-resistant prostate cancer (“CRPC”) whose tumors have progressed with treatments standard. The US FDA has granted Fast Track designation to EPI-7386 for the treatment of adult male patients with mCRPC resistant to standard therapy. ESSA is also conducting a Phase 1/2 clinical trial (NCT05075577) of EPI-7386 in combination with enzalutamide in metastatic CRPC patients who have not yet been treated with second-generation antiandrogen therapies. ESSA retains all rights to EPI-7386 worldwide.
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company focused on developing innovative and proprietary therapies for the treatment of patients with prostate cancer. For more information, please visit www.essapharma.com and follow us on Twitter under @ESSAPharma.
Disclaimer of Forward-Looking Statements
This press release contains certain information which, as presented, constitutes “forward-looking information” within the meaning of the Private Securities Litigation Reform Act of 1995 and/or applicable Canadian securities laws. Forward-looking information involves statements about future events and often deals with expected future business and financial performance, containing words such as “anticipate”, “believe”, “plan”, “estimate”, “expect” and ” intend”, statements that an action or event “may”, “could”, “could”, “should” or “will” be taken or occur, or other similar expressions and includes, but without limitation, statements regarding, presentations regarding updated clinical data from the Phase 1/2 study of EPI-7386, initial clinical data results, including favorable pharmaceutical properties of the ‘EPI-7386, the planned start and timing of the phase 1b study, the nature of the Phase 1/2 trial, the potential clinical benefit of EPI-7386 in combination with approved second generation antiandrogens and other statements surrounding the clinical evaluation of EPI-7386 by the society.
Forward-looking statements and information are subject to various known and unknown risks and uncertainties, many of which are beyond ESSA’s ability to control or predict, and which may cause ESSA’s actual results, performance or achievements to be materially different from those expressed or expressed. implicit in this fact. Such statements reflect ESSA’s current beliefs regarding future events, are subject to risks and uncertainties and are necessarily based on a number of estimates and assumptions which, although considered reasonable by ESSA at the date of these statements, are inherently subject to significant scientific, commercial, economic, competitive, political and social uncertainties and contingencies. In making forward-looking statements, ESSA may make various important assumptions, including, but not limited to, (i) the accuracy of ESSA’s financial projections; (ii) obtaining positive results from clinical trials; (iii) obtain necessary regulatory approvals; and (iv) general business, market and economic conditions.
Forward-looking information is prepared based on assumptions about those risks, uncertainties and other factors set forth herein and in ESSA’s Quarterly Report on Form 10-Q dated August 4, 2022 under the heading “Risk Factors”, a copy of which is available on ESSA’s profile on EDGAR at www.sec.gov and on the SEDAR website at www.sedar.com, and as otherwise disclosed from time to time on ESSA’s EDGAR and SEDAR profiles. Forward-looking statements are made based on the beliefs, estimates and opinions of management as of the date the statements are made and ESSA undertakes no obligation to update forward-looking statements if such beliefs, estimates and opinions or other circumstances were to change unless necessary. by applicable United States and Canadian securities laws. Readers are cautioned against attributing undue certainty to forward-looking statements.
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