NEWARK, N.J., Sept. 28, 2016 /PRNewswire/ -- Symbiomix, a biopharmaceutical company bringing innovative medicines to
The educational reception comes on the heels of Symbiomix recently announcing that it is accelerating plans for the commercial launch of Solosec™ (secnidazole) oral granules following the presentation of clinical results from its second pivotal trial with the drug candidate at last month's Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting. Symbiomix has completed clinical development of Solosec™ as a single oral dose therapy for the treatment of bacterial vaginosis (BV) – the most prevalent gynecological infection in the U.S. – and is on target to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2016 in support of a planned commercial launch in the second half of 2017.
In a short presentation during the reception entitled, "The ABCs of Bacterial Vaginosis (BV): Abnormal Flora, Bothersome Symptoms, Chronicity, and More," Alisa Pascale, DNP, WHNP-BC, Nurse Practitioner for the Vulvovaginal Disorders Program & Gynecology at Massachusetts General Hospital (MGH) and Clinical Instructor at the MGH Institute of Health Professions, will discuss the prevalence of BV and its relevance in women's healthcare, as well as treatment needs.
"NPWH is a perfect venue for building educational awareness about BV," said Ms. Pascale. "BV affects more than 20 million women in the United States annually, so every nurse practitioner will encounter patients with this infection at some point in his/her career. It's essential that we are educated on its prevalence and impact, as well as how to treat this widespread infection and how to manage recurrences."
The Symbiomix medical team will also present three posters during the educational reception on topics pertaining to BV and clinical data with Solosec™.
"Nurse practioners are often on the front line of patient care, and we want to help ensure that more of them are aware of the immense impact of BV, particularly if it is left untreated or is improperly treated," said Joseph L. Amprey, MD, PhD, Symbiomix Co-Founder, Head of Medical Affairs, and Chief Business Officer.
Solosec™, previously known as SYM-1219, is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties. Solosec™ is anticipated to be the first and only single-dose oral therapy approved for BV, which may lead to better adherence to therapy and therefore better patient outcomes. In clinical trials Solosec™ demonstrated efficacy for the treatment of BV with only a single, oral, two-gram dose, thereby additionally providing excellent safety, tolerability and adherence.
Solosec™ has been designated a Qualified Infectious Disease Product (QIDP) by the FDA for the treatment of BV and received Fast Track designation from the agency in 2015. QIDP designation makes Solosec™ eligible for Priority Review and at least 10 years of market exclusivity.
About Bacterial Vaginosis (BV)
BV is the most prevalent gynecological infection in the U.S. among women ages 15 to 44 [1,2]. Today more than four million women are treated in the US for BV annually . More than 50 percent of women treated for BV have a recurrence within 12 months .
The U.S. Centers for Disease Control and Prevention (CDC) has stated that BV can cause serious health risks, including:
BV disproportionately affects disadvantaged populations, including women of color, and may contribute to persistent disparities in women's health outcomes [5,6].
BV has a significant impact on the work productivity and quality-of-life of affected women, with 60% of recurrent sufferers reporting a negative impact on work attendance, job performance and productivity, and 95% reporting a severe restriction in intimate partner relations [7,8].
The current recommended regimen of a first-generation nitroimidazole requires twice-a-day dosing for seven days for a total administration of seven grams of drug. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent . Poor adherence to anti-infective therapy is a problem that increases with the length and complexity of the drug regimen, and can lead to treatment failures, recurrent disease and the more rapid development of resistant microorganisms . These, in turn, may lead to higher health care costs, including increased out-of-pocket expenses, increased office visits and tests, additional treatment costs, and lost productivity .
About Symbiomix Therapeutics, LLC
Symbiomix (sim-bye-OH-mix) is a biopharmaceutical company bringing innovative medicines to market for prevalent gynecological infections that can have serious health consequences. The Company's lead investigational drug Solosec™ (secnidazole) oral granules, a potent, next-generation 5-nitroimidazole antibiotic, is anticipated to be the first and only single-dose oral treatment approved for bacterial vaginosis (BV). Symbiomix was founded in 2012 by a team of experienced industry professionals and entrepreneurs and is backed by three of the world's leading healthcare venture capital firms: OrbiMed, F-Prime Capital Partners, and HBM Partners. Symbiomix is based in New Jersey, with additional offices in Maryland and Connecticut. Please visit www.symbiomix.com and follow the Company on LinkedIn and Twitter for more information.
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SOURCE Symbiomix Therapeutics, LLC
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