Sermonix Pharmaceuticals LLC, a specialty pharmaceutical company focused on the development and commercialization of emerging late-stage women’s health products, today announced researchers will present a scientific poster about its investigational drug, lasofoxifene, at the upcoming American Society for Bone and Mineral Research Annual Meeting (ASBMR). The meeting takes place in Seattle, Washington from October 9 to 12.
The scientific poster titled, “Lasofoxifene 0.25 mg Compared with Raloxifene 60 mg for Effects on Bone Mineral Density and Markers of Bone Turnover: Results from the
Phase III Comparison of Raloxifene and Lasofoxifene (CORAL) Trial,” will be presented by Dr. Michael McClung, M.D., Director of the Oregon Osteoporosis Center.
“These results confirm the superiority of investigational lasofoxifene over raloxifene on skeletal endpoints and, combined with the vertebral and non-vertebral fracture protection of lasofoxifene shown in the PEARL trial, could make lasofoxifene an attractive treatment option for younger postmenopausal women at risk for osteoporosis or fracture,” stated Dr. McClung.
Lasofoxifene has been evaluated in more than 15,000 women in a comprehensive worldwide phase I-III clinical development program that includes the PEARL, OPAL, GARNET, CORAL and other trials. In addition to its positive impact on VVA, clinical studies have shown that lasofoxifene reduces the risk of vertebral fractures by 42 percent and non-vertebral fractures by 25 percent compared to placebo. Sermonix plans to seek FDA approval – and approval in other territories – for several women’s health indications, including postmenopausal osteoporosis and symptoms of vulvovaginal atrophy.
“This head-to-head comparison 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 month, compared to raloxifene,” said David Portman, M.D., Chief Executive Officer of Sermonix. “Lasofoxifene could potentially provide a more effective alternative to the most-widely used and currently available SERM.”
Lasofoxifene – a SERM, also known as an estrogen agonist/antagonist – was originally developed through a collaboration between Ligand Pharmaceuticals and Pfizer. Pfizer developed the oral 0.5 mg form of lasofoxifene tartrate for osteoporosis under the proposed trade name Fablyn®. In 2009, it was not approved by the FDA, however in Europe that year lasofoxifene was approved for osteoporosis treatment by the EMEA. While pursuing FDA approval, Pfizer acquired Wyeth and its Conbriza® (bazedoxifene), a similar SERM product. Pfizer never marketed lasofoxifene in Europe and subsequently all rights to lasofoxifene reverted back to Ligand in 2011. Sermonix obtained licensing rights to oral lasofoxifene from Ligand in February 2015.
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 II and Phase III 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.