Recommended Phase 2 dose regimen identified as
masofaniten 600mg BID combined with
enzalutamide 160mg QD
Phase 2 head-to-head portion of the study to
commence enrollment immediately
Updated Phase 1 results selected for a poster
presentation at ESMO 2023
SOUTH
SAN FRANCISCO, Calif. and VANCOUVER, Canada, Sept. 18,
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 the initiation of
the Phase 2 portion of its
Phase 1/2 study evaluating its lead candidate,
masofaniten (formerly known as EPI-7386), a first-in-class
N-terminal domain androgen receptor inhibitor, in combination with
Astellas and Pfizer's antiandrogen enzalutamide in patients with
metastatic castration-resistant prostate cancer ("mCRPC") naïve to
second-generation antiandrogens.
Updated results from the first four cohorts of patients from the
Phase 1 dose escalation portion of the Phase 1/2
study have been selected for a poster presentation at the upcoming
European Society of Medical Oncology ("ESMO") Congress taking place
October 20-24, 2023, in Madrid, Spain.
"Initiation of the randomized Phase 2 portion
of this study investigating the combination of masofaniten and
enzalutamide (the "Combination") is a significant milestone for
ESSA and we look forward to reporting updated results from the
Phase 1 dose equilibration portion of the study
next month at ESMO 2023," stated David
Parkinson, M.D., President and CEO of ESSA. "The favorable
safety profile observed to date with the Combination has led the
safety review board to agree that we can proceed forward into the
head-to-head comparison portion of the study with the dose regimen
studied in Cohort 4 as our recommended
Phase 2 dose. We look forward to further
elucidating the Combination's potential to improve long-term
clinical benefit for patients with mCRPC. We plan to provide
guidance for timing of the public disclosure of initial data once
the Phase 2 portion has been underway for several
months."
The Phase 2 dose expansion portion of the
study is a two-arm, randomized, open-label study (NCT05075577) that
will evaluate the safety, tolerability and preliminary efficacy
of masofaniten, and is expected to enroll approximately 120
patients. Patients will continue to receive androgen deprivation
therapy and will be randomized 2:1 to receive either the
combination of masofaniten (600mg twice-daily ("BID")) and
enzalutamide (160mg once daily ("QD")) or enzalutamide
(160mg QD) as a single agent. Patients may remain
on study treatment as long as they are tolerating treatment without
disease progression based on RECIST v1.1 and/or
Prostate Cancer Clinical Trials Working Group 3
(PCWG3) criteria.
Details for the ESMO 2023
Presentation
Title: Phase 1/2 Trial of Oral EPI-7386 in Combination
with Enzalutamide (Enz) Compared to Enz Alone in Metastatic
Castration-Resistant Prostate Cancer (mCRPC) Subjects: Current
Phase 1 (P1) results
Speaker: Andrew L.
Laccetti
Presentation #: 1813P
Date: Sunday, October 22,
2023
About Masofaniten
Masofaniten (formerly known as EPI-7386) is a first-in-class
investigational, highly selective, oral, small molecule inhibitor
of the N-terminal domain ("NTD") of the androgen receptor ("AR").
Masofaniten's unique mechanism of action disrupts the AR signaling
pathway, the primary pathway that drives prostate cancer growth, by
selectively binding to the 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 (NCT05075577) in
combination with enzalutamide in patients with metastatic
castration-resistant prostate cancer (mCRPC) naïve to
second-generation antiandrogens. ESSA is also conducting a Phase 1
monotherapy study (NCT04421222) in patients with mCRPC whose tumors
have progressed on standard-of-care therapies. The U.S. Food and
Drug Administration has granted Fast Track designation to
masofaniten for the treatment of adult male patients with mCRPC
resistant to standard-of-care treatment. ESSA retains all rights to
masofaniten 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 and LinkedIn.
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 presentations with respect to the
Phase 1 and Phase 1/2 study,
the timing of the Phase 2 portion of the
combination study, the Combination's potential to improve long-term
clinical benefit for patients with mCRPC, the evaluation of
the safety, tolerability and preliminary efficacy of masofaniten in
the Phase 2 study, enrollment in the
Phase 2 study and other statements surrounding
the Company's evaluation of masofaniten.
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 Annual Report on Form 10-K dated
December 13, 2022, under the heading "Risk
Factors", a copy of which is available on ESSA's profile on EDGAR
at www.sec.gov and on SEDAR+ at www.sedarplus.ca, 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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