Sermonix Announces FDA Acceptance of IND Application; Will Begin Phase 2 Trial of Lasofoxifene for Targeted Treatment of Wome...
December 10 2018 - 10:00AM
Sermonix Pharmaceuticals LLC, a privately held biopharmaceutical
company focused on the development and commercialization of
female-specific oncology products, today announced that the U.S.
Food and Drug Administration (FDA) accepted the company’s
Investigational New Drug (IND) application, indicating that
Sermonix may proceed directly to a Phase 2 clinical study in the
personalized medicine arena involving its lead investigational
drug, lasofoxifene.
The open-label, randomized, multi-center study is expected to
begin enrollment in early 2019 and will evaluate the activity of
oral lasofoxifene versus intramuscular fulvestrant for the
treatment of postmenopausal women with locally advanced or
metastatic estrogen receptor-positive (ER+)/HER2- breast cancer
with an ESR1 mutation.
“We are delighted the IND application was favorably reviewed by
the FDA and brings us ever closer to delivering a novel endocrine
treatment option for these women in great need,” said Sermonix
Chairman Dr. Anthony Wild. “This marks an important milestone in
Sermonix’s effort to develop lasofoxifene as a precision medicine
for women with advanced breast cancer.”
A large amount of clinical data from earlier non-oncology
development, along with new, compelling preclinical data have
enabled Sermonix to commence directly into the Phase 2 study. The
study will include postmenopausal women with ESR1 mutations,
identified using a liquid biopsy clinical trial assay, who have
progressed after aromatase inhibitor and CDK 4/6 inhibitor therapy.
ESR1 mutations occur in up to 40 percent of women with metastatic
breast cancer and may confer a worse prognosis and poor response to
currently available endocrine treatments1.
“As ESR1 mutations are highly prevalent in ER+ metastatic breast
cancer, we look forward to demonstrating lasofoxifene’s potential
promise in this area of significant unmet medical need,” said Dr.
David Portman, Sermonix founder and chief executive officer.
“Acceptance of the IND application allows us to maintain momentum
in the important effort to bring lasofoxifene to patients who
desperately need more options for this incurable disease, so we are
thrilled to receive this news from the FDA.”
1 Chandarlapaty S et al, JAMA oncology 2016 Oct
1;2(10):1310-1315)
About LasofoxifeneLasofoxifene is an
investigational, nonsteroidal selective estrogen receptor modulator
(SERM), which Sermonix licensed from Ligand Pharmaceuticals Inc.
(NASDAQ: LGND) and has been studied in previous comprehensive Phase
1-3 non-oncology clinical trials in more than 15,000 postmenopausal
women worldwide.
Lasofoxifene’s binding affinity and activity in mutations of the
estrogen receptor could potentially hold promise for patients who
have acquired endocrine resistance and ESR1 mutations, a common
mutation in the metastatic setting and an area of high unmet
medical need. Lasofoxifene’s novel activity in ESR1 mutations was
recently discovered and Sermonix has exclusive rights to develop
and commercialize it in this area. A potent, well-characterized and
bioavailable SERM, lasofoxifene, if approved, could play a critical
role in the personalized treatment of advanced ER+ breast
cancer.
About SermonixSermonix Pharmaceuticals LLC is a
biopharmaceutical company with a targeted focus on bringing
female-specific oncology products through proof of concept,
preclinical and clinical development, and regulatory approval. The
company was founded in 2014 by David Portman, M.D., a leading
clinical researcher and expert in women’s health, menopause and
selective estrogen receptor modulator (SERM) therapy. Sermonix has
as its lead product oral lasofoxifene. The Sermonix management
team, led by Dr. Portman, has significant experience in all stages
of the drug development and regulatory process. Paul Plourde, M.D.,
vice president of oncology clinical development, was previously
with AstraZeneca, where he was instrumental in the development and
approval of tamoxifen, Arimidex® and Faslodex®. Barry Komm, Ph.D.,
chief scientific officer, was former head of the SERM program at
Wyeth and Pfizer, playing a key role in the development and
approval of bazedoxifene and Duavee®. Elizabeth Attias, M.M.Sc.,
Sc.D., vice president of business development, has extensive
experience in pharmaceutical drug commercialization. Simon Jenkins,
Ph.D. vice president of operations, has over 30 years of experience
in global drug development leadership roles across a range of
therapeutic areas. Sermonix non-executive chairman of the board is
Anthony Wild, Ph.D., former president of both Parke-Davis
Pharmaceuticals and Warner-Lambert’s Pharmaceutical Division. Learn
more at http://sermonixpharma.com.
Contact:David Portman, MDCEO and Founder, Sermonix
Pharmaceuticalsdportman@sermonixpharma.com614-582-6849
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