NEWARK, N.J., Oct. 25, 2016 /PRNewswire/ -- Symbiomix, a biopharmaceutical company bringing innovative medicines to market for prevalent gynecological infections, today announced that data recently presented at the International Society for Quality of Life Research 23rd Annual Conference in Copenhagen, Denmark are the results of a Symbiomix-sponsored study examining perspectives on bacterial vaginosis (BV) among clinicians and patients. The conference took place October 19-22, 2016.
The study, conducted and presented by Optum and Pharmerit and based on interviews with 20 women with BV as well as 10 clinicians, demonstrated some congruence of symptoms and quality of life impacts of vaginosis based upon clinician and patient reports. The study revealed unique patient insights into symptoms and treatment experiences and the impact on their work/life function, risk of social isolation, and negative influence on intimacy. In addition, researchers found that many patients did not have a high degree of knowledge about the disease, including how to recognize BV symptoms, which led to prolonged suffering.
"This study found important information about common symptoms and social, functional and emotional impacts reported by both clinicians and patients, and supports the need for more research to improve treatment regimens and outcomes," said Joseph L. Amprey, MD, PhD, Symbiomix Co-Founder, Head of Medical Affairs, and Chief Business Officer. "Patient education strategies are important, given the prolonged suffering, potential worsening of symptoms, and risks of BV when treatment is delayed."
Poster Number 2112. Qualitative Investigation of Patient and Clinician Perspectives on Symptoms and Quality of Life Burden of Bacterial Vaginosis, a Common Vaginal Infection in Women of Reproductive Agei. Friday Poster Session 2 – Women's Health.
The poster presentation comes as Symbiomix accelerates plans for the commercial launch of Solosec™ (secnidazole) oral granules. Symbiomix has completed clinical development of Solosec™ as a single oral dose therapy for the treatment of BV – the most prevalent gynecological infection in the U.S.
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:
- Increasing the risk of HIV transmission;
- Increasing the risk of contracting other sexually transmitted diseases, such as chlamydia and gonorrhea, which, if untreated, may lead to pelvic inflammatory disease and infertility; and,
- In pregnant women, increasing the risk of delivering a baby too early .
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.
- Allsworth J.E., Peipert, J.F. Prevalence of bacterial vaginosis: 2001-2004 National Health and Nutrition Examination Survey data. Obstetrics and gynecology 2007;109:114-20.
- IMS Health, 2014
- Bradshaw CS, et al. (2006). "High recurrence rates of bacterial vaginosis over the course of 12 months after oral metronidazole therapy and factors associated with recurrence" J Infect Dis. 2006 Jun 1;193(11):1478-86.
- Fiscella, K. (1996). "Racial disparities in preterm births. The role of urogenital infections." Public Health Rep 111(2): 104-113.
- Payne et al. (2010). "Evidence of African-American women's frustrations with chronic, recurrent bacterial vaginosis." Jn AANP 22(2010) 101-108.
- Bilardi et al. (2013). "The Burden of Bacterial Vaginosis: Women's Experience of the Physical, Emotional, Sexual and Social Impact of Living with Recurrent Bacterial Vaginosis." PlusOne Sept 2013, vol 8, issue 9.
- Bartley, J.B., et al. (2004). "Personal digital assistants used to document compliance of bacterial vaginosis treatment." Sex Transm Dis 31(8): 488-491.
- Kardas, P. (2002). "Once-Daily Dosage Secures Better Compliance With Antibiotic Therapy of Respiratory Tract Infections Than Twice-Daily Dosage." WONCA Europe 2002 Conference, London.
- Kardas, P., Bishai, W., (2006). "Compliance in anti-infective medicine." Adv Stud Med 2006; 6(7C):S652:S658.
i Dhatt H, Bayliss M, Stroupe A, Horodniceanu EG, Brigaitis J, Miller K, Lasch K. Qualitative Investigation of Patient and Clinician Perspectives on Symptoms and Quality of Life Burden of Bacterial Vaginosis, a Common Vaginal Infection in Women of Reproductive Age. Quality of Life Research: Volume 25, Issue 1 Supplement, October 2016
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SOURCE Symbiomix Therapeutics, LLC