HOUSTON and VANCOUVER, BC, Jan. 19,
2022 /CNW/ - ESSA Pharma Inc. (NASDAQ: EPIX) ("ESSA"
or the "Company"), a clinical-stage pharmaceutical company focused
on developing novel therapies for the treatment of prostate cancer,
today announced the first patient dosed in the Company-sponsored
Phase 1/2 study to evaluate the safety, tolerability and
preliminary efficacy of ESSA's lead product candidate, EPI-7386, a
first-in-class N-terminal domain androgen receptor inhibitor, in
combination with Astellas Pharma Inc.'s ("Astellas") and Pfizer
Inc.'s ligand-binding domain androgen receptor inhibitor,
enzalutamide, in patients with metastatic castration-resistant
prostate cancer ("mCRPC").
"The initiation of this combination trial with Astellas is a
watershed moment for ESSA as we investigate the potential clinical
benefit of inhibiting the androgen receptor through two independent
pathways in the treatment of patients with mCRPC who have not yet
received treatment with a second-generation antiandrogen drug,"
said Dr. David. R. Parkinson, Chief Executive Officer, ESSA Pharma
Inc. "Combining our two therapies will simultaneously target both
ends of the androgen receptor. In preclinical models, we have seen
that combining EPI-7386 with current antiandrogens can lead to
deeper and broader inhibition of androgen biology. This Phase 1/2
trial marks the first of a series of clinical studies to evaluate
EPI-7386 in combination with current antiandrogen therapies in
patients with mCRPC, with additional Phase 1/2 combination trials
anticipated to begin in 2022."
The Phase 1/2 clinical trial (NCT05075577) begins with an
initial phase 1 portion wherein the doses of each drug are adjusted
followed by a phase 2 portion wherein the single agent enzalutamide
is compared to the combination of enzalutamide and EPI-7386. The
phase 1 study is expected to enroll up to 30 mCRPC patients who
have not yet been treated with second-generation antiandrogen
therapies. The goal of the phase 1 portion of the study is to
evaluate the safety and tolerability of the drug combination and
establish the recommended phase 2 doses for EPI-7386 and
enzalutamide when dosed in combination. The phase 2 study is
expected to enroll 120 mCRPC patients who have not yet been treated
with second-generation antiandrogen therapies. The goal of the
phase 2 part of the study is to evaluate the safety, tolerability
and antitumor activity of EPI-7386 in combination with a fixed dose
of enzalutamide compared with enzalutamide as a single
agent.
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
metastatic castration-resistant prostate cancer whose tumors have
progressed on current standard-of-care therapies. The Phase I
clinical trial of EPI-7386 began in calendar Q3 of 2020 following
FDA allowance of ESSA's Investigational New Drug application and
Health Canada acceptance. EPI-7386 is also currently being studied
in a Phase 1/2 clinical trial (NCT05075577) in mCRPC patients who
have not yet been treated with second-generation antiandrogen
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 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.com and follow
us on Twitter under @ESSAPharma.
About Prostate Cancer
Prostate cancer is the
second-most commonly diagnosed cancer among men and the fifth most
common cause of male cancer death worldwide (Globocan, 2018).
Adenocarcinoma of the prostate is dependent on androgen for tumor
progression and depleting or blocking androgen action has been a
mainstay of hormonal treatment for over six decades. Although
tumors are often initially sensitive to medical or surgical
therapies that decrease levels of testosterone, disease progression
despite castrate levels of testosterone can lead to mCRPC. The
treatment of mCRPC patients has evolved rapidly over the past ten
years. Despite these advances, many patients with mCRPC fail or
develop resistance to existing treatments, leading to continued
disease progression and limited survival rates.
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 the combination of EPI-7386 and
enzalutamide simultaneously targeting both ends of the
androgen receptor, the combination of EPI-7386 with current
antiandrogens leading to deeper and broader inhibition of androgen
biology, the anticipated timeline of additional Phase 1/2
combination trials, and the methodology, goals and details of the
Phase 1/2 clinical trial.
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 16, 2021 under the heading "Risk Factors",
a copy of which is available on ESSA's profile on EDGAR at
www.sec.gov.com 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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