SOUTH
SAN FRANCISCO, California and VANCOUVER, Canada, Oct. 31,
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, today announced that Janssen Research and Development
("Janssen") is suspending enrollment into the Phase 1 clinical
study of EPI-7386 with apalutamide or EPI-7386 with abiraterone
acetate plus prednisone in metastatic castration-resistant prostate
cancer ("mCRPC") patients as a result of operational recruitment
challenges.
Before suspending enrollment, Janssen treated three mCRPC
patients (pre-chemotherapy) with the combination of EPI-7386 and
apalutamide or abiraterone acetate plus prednisone for up to four
months of therapy. In all three patients, the combination of both
investigational drug products was safe and well tolerated, and
yielded sufficient exposures of each investigational drug product,
indicative of pharmacological activity. Initial clinical activity
was observed in some patients, with two of the three patients
achieving a prostate-specific antigen ("PSA") reduction of 90%
("PSA90") within 12 weeks.
"While we are disappointed that Janssen will not be completing
this study, we thank Janssen for the conduct of the study to date
and the patients who participated in the study. We are encouraged
by the favorable safety, pharmacokinetic, and initial clinical
activity in these patients as these data further support the data
generated in the EPI-7386 combination study with enzalutamide that
ESSA is conducting. We are in discussions with Janssen to supply
abiraterone acetate and apalutamide for an ESSA-sponsored
combination study and expect to provide more details in the coming
months," said David Parkinson, Chief
Executive Officer of ESSA.
About EPI-7386
EPI-7386 is an investigational, highly-selective, oral, 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 on standard-of-care
therapies. The U.S. FDA has granted Fast Track designation to
EPI-7386 for the treatment of adult male patients with mCRPC
resistant to standard-of-care treatment. 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 novel and proprietary therapies for the treatment of
patients with prostate cancer. For more information, please visit
www.essapharma.comand follow us on Twitter under @ESSAPharma.
Forward-Looking Statement
Disclaimer
This 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 that relate to future events and often addresses
expected future business and financial performance, containing
words such as "anticipate", "believe", "plan", "estimate",
"expect", and "intend", statements that an action or event "may",
"might", "could", "should", or "will" be taken or occur, or other
similar expressions and includes, but is not limited to, statements
regarding, the results of the initial clinical data, including the
favorable pharmaceutical properties of EPI-7386, the potential
clinical benefit of EPI-7386 in combination with approved
second-generation antiandrogens, the fact that the combination of
both investigational drug products could be pharmacologically
active in patients and the potential for future ESSA-sponsored
studies to evaluate EPI-7386 in combination with Janssen's
therapies.
Forward-looking statements and information are subject to
various known and unknown risks and uncertainties, many of which
are beyond the ability of ESSA to control or predict, and which may
cause ESSA's actual results, performance or achievements to be
materially different from those expressed or implied thereby. Such
statements reflect ESSA's current views with respect to future
events, are subject to risks and uncertainties and are necessarily
based upon a number of estimates and assumptions that, while
considered reasonable by ESSA as of the date of such statements,
are inherently subject to significant medical, scientific,
business, economic, competitive, political and social uncertainties
and contingencies. In making forward looking statements, ESSA may
make various material assumptions, including but not limited to (i)
the accuracy of ESSA's financial projections; (ii) obtaining
positive results of clinical trials; (iii) obtaining necessary
regulatory approvals; and (iv) general business, market and
economic conditions.
Forward-looking information is developed based on assumptions
about such risks, uncertainties and other factors set out 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 management's
beliefs, estimates and opinions on the date that statements are
made and ESSA undertakes no obligation to update forward-looking
statements if these beliefs, estimates and opinions or other
circumstances should change, except as may be required by
applicable United States and
Canadian securities laws. Readers are cautioned against attributing
undue certainty to forward-looking statements.
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SOURCE ESSA Pharma Inc