Initial data from multi-center safety study is expected in first half of 2022
COLUMBUS, Ohio, June 28, 2021 (GLOBE NEWSWIRE) -- Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to treat ESR1-mutated metastatic breast and gynecological cancers, today announced that enrollment has been completed for its Phase 2 clinical trial collaboration of its lead investigational drug, lasofoxifene, in combination with Eli Lilly and Company’s FDA-approved CDK 4 and 6 inhibitor, abemaciclib. Sermonix expects initial data from the trial to be available in the first half of 2022.
“Combination therapy in the metastatic setting is becoming quite commonplace and the potential to pair a well-tolerated endocrine therapy with a CDK 4/6 inhibitor in women with an ESR1 mutation is important from a clinical perspective, thus it is vital to assess safety and tolerability of these agents used concomitantly to optimize progression-free survival,” said Dr. David Portman, Sermonix founder and chief executive officer. “We are delighted to have promptly completed enrollment and thank our participants, their families and clinical centers for supporting our efforts.”
The open-label, multi-center study is evaluating the safety of lasofoxifene in combination with abemaciclib for the treatment of pre- and postmenopausal women with locally advanced metastatic estrogen receptor-positive (ER+)/HER2- breast cancer and an ESR1 mutation. It is Sermonix’s second Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study and is known as ELAINE 2.
Sermonix partnered with Tempus, a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare, to assist in identifying and enrolling patients in the ELAINE 2 study. Leveraging Tempus’ AI capabilities and the TIME Trial® program, Sermonix was able to find patients in real-time, especially eligible ESR1+ patients who are treated in the community setting.
Preclinical models of invasive breast cancer at the University of Chicago – recently published in the journal Breast Cancer Research – identified synergy between lasofoxifene, a selective estrogen receptor modulator (SERM), and a CDK 4 and 6 inhibitor in the presence of ESR1 mutations.
“The completion of ELAINE 2 enrollment marks an important preparative step toward conducting a larger efficacy study of lasofoxifene in combination with a CDK 4/6 inhibitor,” said Dr. Paul Plourde, Sermonix vice president of clinical development. “We are delighted with the fast study enrollment – particularly given the challenges of the pandemic – and the momentum of lasofoxifene and our ELAINE program as we look to share initial data early in 2022.”
For more information about the ELAINE studies, visit https://www.elainestudy.com.
Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator (SERM), which Sermonix licensed globally 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 bioavailability and activity in mutations of the estrogen receptor could potentially hold promise for patients who have acquired endocrine resistance due to ESR1 mutations, a common finding in the metastatic setting and an area of high unmet medical need. Lasofoxifene’s novel activity in ESR1 mutations was discovered at Duke University and Sermonix has exclusive rights to develop and commercialize the product in this area. Lasofoxifene, a potent, oral SERM could, if approved, play a critical role in the targeted precision medicine treatment of advanced ER+ breast cancer.
Abemaciclib (trade name Verzenio®) is a CDK4 and 6 inhibitor and the first and only oral tablet of its kind that can be taken every day for the treatment of HR+, HER2– metastatic breast cancer. It is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer, in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy; in combination with fulvestrant for women with disease progression following endocrine therapy; or as a single agent for adult patients with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Sermonix Pharmaceuticals Inc. is a privately held biopharmaceutical company focused on the development of female-specific oncology products and is currently undertaking two Phase 2 clinical studies of lasofoxifene, its lead investigational drug. Sermonix Pharmaceuticals 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. 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, has many decades of experience in the oncology drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in SERM biology. Miriam Portman, M.D., is chief operating officer. Elizabeth Attias, M.M.Sc., Sc.D., chief strategy and development officer, 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. 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 https://sermonixpharma.com/.