EPI-7386 in combination with enzalutamide was
safe and well-tolerated at the doses tested with clinically
relevant drug exposures and deep and durable prostate specific
antigen ("PSA") reductions observed in five of six patients
SOUTH
SAN FRANCISCO, California and VANCOUVER, Canada, Oct. 26,
2022 /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 presentation of updated clinical 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 metastatic castration-resistant prostate cancer ("mCRPC").
Data will be presented in a poster format at the 2022 Prostate
Cancer Foundation ("PCF") Scientific Retreat, taking place
October 27-29, 2022 in Carlsbad, CA.
In the multicenter, open-label Phase 1/2 dose escalation study,
seven mCRPC patients naïve to second generation antiandrogens were
enrolled in the first two cohorts, with escalating doses of
EPI-7386 and a fixed 120mg once a day (QD) dose of enzalutamide.
The study permitted one prior line of chemotherapy. Pharmacokinetic
results from these first two cohorts demonstrated that enzalutamide
exposure was minimally impacted by EPI-7386 while exposures of
EPI-7386 were reduced by coadministration with enzalutamide, but
remained in 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 toxicities observed. One of the
patients in the first cohort discontinued after one cycle of dosing
due to a strong CYP3A inducer concomitant medication which lowered
exposures to both EPI-7386 and enzalutamide and was therefore not
evaluable for efficacy. Anti-tumor activity in the remaining six
patients enrolled demonstrated that four of six of these patients
achieved a PSA90 by 12 weeks of dosing and five of six patients to
date have achieved a PSA90.
"We are encouraged by the rapid and deep PSA responses observed
in the dose escalation study of EPI-7386 in combination with
enzalutamide," stated David
Parkinson, M.D., President and CEO of ESSA. "The therapies
continue to be safe and well-tolerated, and pharmacokinetic results
demonstrate enzalutamide exposure was minimally impacted by
EPI-7386 as expected. We are currently enrolling a third dose
escalation cohort as we optimize the therapeutic dose of EPI-7386
in the combination study in preparation for Phase 2."
Two additional posters will be presented at the conference
highlighting updated results from the first-in-human Phase 1a dose
escalation study of EPI-7386 as a monotherapy in mCRPC patients
failing current second-generation antiandrogens and preclinical
data on ESSA's first-in-class N-terminal domain androgen receptor
protein degrader ("ANITAC"™) program.
Presentation details are as follows:
Title: Oral EPI-7386 in Patients with Metastatic
Castration-Resistant Prostate Cancer: Results from the
First-in-Human Dose Escalation Phase 1a Study
Authors: Andrew Laccetti, et al.
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):
Preliminary Results from the Phase 1 (P1) Dose-optimization
Component of the Study
Authors: Andrew Laccetti, et al.
Title: Advances in the Development of a Targeted
N-Terminal Domain Androgen Receptor Degrader (ANITAC) for the
Treatment of Prostate Cancer
Authors: Nan Hyung Hong, et al.
The three posters are available on the 2022 PCF Scientific
Retreat website and on the "Publications" section of the Company's
website at www.essapharma.com.
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, presentations with respect to updated clinical data from
the Phase 1/2 study of EPI-7386, the results of the initial
clinical data, including the favorable pharmaceutical properties of
EPI-7386, the expected commencement 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 Company's clinical evaluation of EPI-7386.
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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