COLUMBUS, OH (March 31, 2016) – Sermonix Pharmaceuticals LLC, a specialty pharmaceutical company focused on the development and commercialization of emerging late-stage women’s health products, announced today it will deliver an oral presentation related to its investigational drug, lasofoxifene, at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Disease (WCO-IOF-ESCEO) on April 15.
The meeting, held at the Palacio de Ferias y Congresos de Málaga (Fycma) in Málaga, Spain, will feature Sermonix’s presentation: “The Phase 3 Comparison of Raloxifene and Lasofoxifene (CORAL) Trial: Changes in Bone Markers and Bone Mineral Density.”
“Osteoporosis is a serious public health concern in developed countries including within Europe. The incidence of osteoporosis is rising as the population ages, and more than 40%* of postmenopausal women will experience a fracture related to the disease in their lifetime,” said Dr. Michael McClung, the study’s presenting author and Director of the Oregon Osteoporosis Center. “There is a need for effective treatments that can be used safely for many years. My presentation of the CORAL data will confirm that lasofoxifene treatment is more effective in preventing bone loss than is raloxifene. These results, coupled with the known anti-fracture effectiveness of this drug, suggest that lasofoxifene is an attractive treatment option for women with or at risk for postmenopausal osteoporosis.”
Lasofoxifene, evaluated in over 15,000 women in a comprehensive worldwide Phase 1-3 clinical development program that includes the PEARL, OPAL, GARNET and CORAL trials, is an investigational selective estrogen receptor modulator (SERM) and unique in that it has demonstrated reduction in both vertebral and non-vertebral fractures in postmenopausal osteoporosis, improvement of the symptoms of vulvovaginal atrophy (VVA), also now known as genitourinary syndrome of menopause (GSM), and decrease in the incidence of ER+ breast cancer by 83% in patients followed out to 5 years.
With over 3,200 participants, WCO-IOF-ESCEO is the largest educational event for osteoporosis, osteoarthritis and musculoskeletal diseases in Europe.
“We’re looking forward to sharing our findings with the thousands of top researchers and healthcare professionals who attend WCO-IOF-ESCEO,” said David Portman, M.D., Chief Executive Officer and Chief Medical Officer of Sermonix. “This randomized, double-blind, placebo-controlled phase 3 trial of the investigational drug lasofoxifene demonstrated greater bone mineral density (BMD) changes as well as a nearly two-fold higher rate of response, defined as no loss of BMD from baseline at 24 months, compared to raloxifene – the most widely used SERM for osteoporosis.”
More on lasofoxifene
Lasofoxifene — a SERM, also known as an estrogen agonist/antagonist — was originally developed through collaboration between Ligand Pharmaceuticals and Pfizer. Pfizer developed the oral form of lasofoxifene tartrate for osteoporosis under the proposed trade name Fablyn®. While lasofoxifene was never approved in the U.S., in 2009, it was approved in Europe for osteoporosis treatment by the EMEA. However, Pfizer never launched lasofoxifene in Europe and subsequently global rights to lasofoxifene reverted to Ligand in 2011. Sermonix obtained licensing rights to oral lasofoxifene from Ligand in February 2015 and is currently seeking regulatory approval.
Sermonix Pharmaceuticals LLC is a specialty pharmaceutical company focused on bringing new and emerging late-stage women’s health products through clinical development and regulatory approval. Founded in 2014, Sermonix has assembled considerable talent within women’s healthcare clinical development and product commercialization. Dr. David Portman, Sermonix’s founder and CEO, was principal investigator for the Phase 2 and Phase 3 lasofoxifene clinical trials and was actively involved during the drug’s clinical development. Dr. Portman has experience in all stages of the regulatory approval process. James Symons, MS, PhD, is Vice President of Clinical Development at Sermonix and was the global clinical lead for the lasofoxifene development program for vulvovaginal atrophy as well as for multiple women’s health submissions to the FDA during his tenure at Pfizer. Elizabeth Attias, MMSc, ScD, Vice President of Business Development, has experience in all stages of women’s health product assessment, market development, launch and commercialization. Miriam Portman, MD, is the Chief Operating Officer of Sermonix. She is former Co-director and Founder of the Columbus Center for Women’s Health Research and has extensive experience in clinical research, with a focus on FDA regulatory issues, patient recruitment, budgets and contracts.