‘Significant and clinically meaningful’ results support Sermonix’s plans to study oral lasofoxifene’s impact on VVA in women with mBC being treated in ELAINE-3 trial
  COLUMBUS, Ohio, April 29, 2024 (GLOBE NEWSWIRE) — Sermonix Pharmaceuticals Inc., a privately held biopharmaceutical company developing innovative therapeutics to specifically treat metastatic breast cancers (mBC) harboring ESR1 mutations, today announced that an article on the effects of its lead investigational drug, oral lasofoxifene, on moderate to severe vaginal atrophy in postmenopausal women was published April 23, 2024 in Menopause: The Journal of The Menopause Society. The article, “Oral lasofoxifene’s effects on moderate to severe vaginal atrophy in postmenopausal women: two phase 3, randomized, controlled trials,” examined the results of two Phase 3 trials that aimed to demonstrate whether orally administered lasofoxifene improves vaginal signs/symptoms of genitourinary syndrome of menopause. It concluded that “oral lasofoxifene 0.25 and 0.5 mg/d provided significant and clinically meaningful improvements in vaginal signs/symptoms with a favorable safety profile, suggesting beneficial effects of lasofoxifene on genitourinary syndrome of menopause.” “We are very pleased that Menopause, a prestigious peer-reviewed journal, recognizes the significance of these results and lasofoxifene’s potential benefit with respect to vaginal and sexual health,” said Dr. Risa Kagan, the article’s lead author, a clinical professor of obstetrics, gynecology & reproductive sciences at the University of California, San Francisco, and menopause and sexual health consultant at Sutter East Bay Medical Foundation in Berkeley, California. The results support Sermonix’s plans to study oral lasofoxifene’s impact on vulvovaginal atrophy (VVA) during its currently recruiting third Evaluation of Lasofoxifene in ESR1 Mutations (ELAINE) study, known as ELAINE-3. A global registrational Phase 3 study, ELAINE-3 is assessing the efficacy of oral lasofoxifene and Eli Lilly and Company’s CDK4/6 inhibitor abemaciclib (Verzenio®) compared to fulvestrant and abemaciclib in 400 pre- and post-menopausal subjects with locally advanced or metastatic ER+/HER2- breast cancer with an ESR1 mutation. In addition to the primary endpoint of progression-free survival, secondary endpoints will assess the impact of lasofoxifene on urogenital symptoms utilizing the well-studied and validated Functional Assessment of Cancer Therapy – Endocrine Symptoms scale (FACT B-ES). “Women with metastatic breast cancer frequently suffer from debilitating urogenital symptoms, most commonly vaginal dryness and painful intercourse, so we have included patient-reported outcome scales in our ELAINE-3 trial to better understand oral lasofoxifene’s potential benefit in this regard,” said Dr. David Portman, Sermonix founder and chief executive officer. “Clearly, the results demonstrated in the Menopause article are encouraging and supportive, and we are excited to continue this quality-of-life investigation.” To learn more about Sermonix Pharmaceuticals and lasofoxifene, visit https://sermonixpharma.com. For more information about the ELAINE studies, visit https://elainestudy.com and https://DiscoverElaine.com.  
About Sermonix 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. The Sermonix management team, led by founder Dr. David Portman, has significant experience in all stages of the drug development, regulatory and commercialization processes. Paul Plourde, M.D., vice president of oncology clinical development, has many decades of experience at AstraZeneca in the breast cancer drug development arena. Barry Komm, Ph.D., chief scientific officer, is recognized for his expertise in nuclear receptor biology. Miriam Portman, M.D., is co-founder and chief operating officer, with expertise in clinical trial conduct and patient recruitment. 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 SermonixPharma.com. Sermonix Contact: Elizabeth Attias, Sc.D. Chief Strategy and Development Officer EAttias@sermonixpharma.com (973) 723-7832