SOUTH
SAN FRANCISCO, California and VANCOUVER, Canada, Feb. 13,
2023 /PRNewswire/ - 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 further analyses of initial clinical
data from two Phase 1 studies of EPI-7386 in patients with
metastatic castration-resistant prostate cancer ("mCRPC") will be
presented at the 2023 American Society of Clinical Oncology
Genitourinary Cancers Symposium ("ASCO GU"), taking place
February 16-19, 2023, in San Francisco, California and online. EPI-7386
is a first-in-class N-terminal domain androgen receptor ("AR")
inhibitor that suppresses androgen activity through a novel
mechanism of action. The two poster presentations are
available on the ASCO GU Digital Program and the
"Publications" section of the Company's website at
www.essapharma.com.
"We are encouraged that EPI-7386 has continued to be
well-tolerated and safe as well as demonstrate initial anti-tumor
activity both as a monotherapy and in combination with enzalutamide
in patients with metastatic castration-resistant prostate cancer,"
said David Parkinson, MD, President
and CEO of ESSA. "Although the clinical data is still in the early
stages, with longer follow-up we observe that EPI-7386 in
combination with enzalutamide continues to show deep and sustained
prostate-specific antigen ("PSA") declines, which may indicate the
potential for long-term treatment benefits. We look forward to
further exploring the potential clinical benefit of EPI-7386 in
combination with enzalutamide as we look to enroll patients in the
final cohort of the dose escalation study and prepare to enroll
approximately 120 patients in the randomized Phase 2 study at
clinical sites across the U.S., Canada, and Australia."
Presentation Details:
Abstract #179
Title: Phase 1/2 Study of
EPI-7386 in Combination with Enzalutamide (Enz) Compared with Enz
Alone in Subjects with Metastatic Castration-Resistant Prostate
Cancer (mCRPC)
Presenting Author: Andrew Leonard Laccetti, MD, MS,
Memorial Sloan Kettering Cancer Center
Format: Poster
The Phase 1/2 multicenter, open-label clinical trial is
enrolling mCRPC patients on androgen deprivation therapy who are
naïve to second-generation antiandrogens but may have been treated
previously with one line of prior chemotherapy in the metastatic
hormone-sensitive prostate cancer setting. The current presentation
of data is an update on the first two cohorts of patients which was
previously presented at the Prostate Cancer Foundation Scientific
Retreat in October 2022. In this
update, EPI-7386 in combination with enzalutamide continues to be
safe and well-tolerated at the doses tested with clinically
relevant drug exposures of both enzalutamide and EPI-7386 with deep
and durable PSA reductions continuing through 13 cycles of dosing
in some patients. Five of six evaluable patients achieved a PSA90
(≥90% decline in PSA) during the study with these PSA responses
being maintained or further deepening during the course of the
study. These rapid and deep PSA declines occurred both in patients
who have and have not received prior chemotherapy. A further
analysis shows that four of six evaluable patients' PSA levels
reached <0.2 ng/mL, one of the most stringent measures of PSA
decline.
Abstract #177
Title: Oral EPI-7386 in Patients
with Metastatic Castration-Resistant Prostate Cancer
Presenting Author: Russell Kent
Pachynski, MD, Washington
University School of Medicine
Format: Poster
The data reported are from 45 heavily pretreated mCRPC patients
from both the phase 1a and 1b patient
populations. Updated results of EPI-7386 as a monotherapy
demonstrate that EPI-7386 continues to be safe and well-tolerated
with clinically relevant drug exposures reached at all dose levels
tested. Similar to what was reported previously at the
Prostate Cancer Foundation Scientific Retreat in October 2022, clinically important signals of
anti-tumor activity of EPI-7386 were observed in a subset of these
patients (those with less than 3 lines of treatment for mCRPC, lack
of visceral disease, no prior chemotherapy and lack or few non-AR
mutations).
Part 1b of the study is open with
enrollment focused on pre-chemotherapy, post-second-generation
antiandrogen treated mCRPC patients in one cohort, and
treatment-naïve non-mCRPC patients in a window of opportunity
proof-of-concept second cohort. Two doses will be evaluated based
on FDA Project Optimus recommendations.
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 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.com and 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 presentation of clinical data from the Phase 1
studies, the clinical benefit of EPI-7386 in combination with
enzalutamide, the enrollment of patients in the Phase 2 study, the
results of clinical data in the combination and monotherapy
studies, and the evaluation of the dose schedules in Part
1b of the monotherapy study.
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 February 7, 2023 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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