Symbiomix Presents New Data On Solosec
Published: Aug 10, 2017
- Three presentations on Solosec™ (secnidazole) oral granules to be presented at IDSOG 2017
- NDA for Solosec™ for the treatment of bacterial vaginosis (BV) undergoing priority review by FDA
- If approved, Solosec™ will be the first and only single-dose oral therapy for BV
PARK CITY, Utah--(BUSINESS WIRE)--Symbiomix Therapeutics today announced the presentation of new data on single-dose Solosec™ at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) 2017 Annual Meeting. Solosec™ is a next-generation, investigational 5-nitroimidazole antibiotic with unique pharmacokinetic properties, and is the first and only single-dose oral therapy in development for bacterial vaginosis (BV).
BV is the most prevalent gynecological infection in the United States among women ages 15 to 44, with more than 4 million women treated annually. [1,2,3] More than 50 percent of women treated for BV have a recurrence within 12 months. 
“The presentations at this year’s IDSOG meeting reinforce our commitment to bringing innovative medicines to market for women’s health infections, such as BV, that can have serious health consequences,” said Helen Pentikis, Ph.D., Chief Scientific Officer of Symbiomix.
At IDSOG 2017, the following data will be presented:
- A post hoc analysis of secnidazole 2 g for the treatment of bacterial vaginosis: effect of 2016 FDA guidance on clinical response rates in a subpopulation of patients 
- Sensitivity of trichomonas isolates to secnidazole and metronidazole 
- A review of the pharmacokinetic properties of SYM-1219, a single oral dose granule formulation containing 2 g of secnidazole, for the treatment of bacterial vaginosis 
“The most commonly prescribed oral BV treatment regimen today requires twice-a-day dosing for seven days, and adherence has been shown to be only approximately 50 percent,” said Jane Schwebke, M.D., Professor of Medicine and Infectious Diseases at the University of Alabama at Birmingham. “The new Solosec™ data presented at IDSOG this year are encouraging and a single-dose therapy for BV would be most welcome.”
The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for Solosec™ in March 2017. In accordance with the FDA's priority six-month review designation, the Agency has established a user-fee goal date under the Prescription Drug User Fee Act (PDUFA) of September 2017.
About Bacterial Vaginosis (BV)
BV is the most prevalent gynecological infection in the U.S. among women ages 15 to 44. [1,2] The U.S. Centers for Disease Control and Prevention (CDC) has stated that BV can cause serious health risks, including:
- In pregnant women, increasing the risk of delivering a baby too early;
- 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
- Increasing the risk of HIV transmission. 
BV has a significant impact on the work productivity and quality-of-life of affected women, with 60 percent of recurrent sufferers reporting a negative impact on work attendance, job performance and productivity, and 95 percent reporting a severe restriction in intimate partner relations. [8,9]
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 healthcare 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 https://symbiomix.com/ and follow the Company on LinkedIn and Twitter for more information.
|1.||Allsworth, J.E., Peipert, J.F. (2007). “Prevalence of Bacterial Vaginosis: 2001-2004 National Health and Nutrition Examination Survey Data.” Obstetrics & Gynecology 109:114-20.|
http://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm. Accessed August 7, 2017.
|3.||IMS Health, 2014.|
|4.||Bradshaw, C.S., 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. Jun 1;193(11):1478-86.|
|5.||Nyirjesy P, Amprey J, Padula M. A post hoc analysis of secnidazole 2 g for the treatment of bacterial vaginosis: effect of 2016 FDA guidance on clinical response rates in a subpopulation of patients. Presented at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) 2017 Annual Meeting; August 10, 2017; Park City, Utah.|
|6.||Ghosh A. Susceptibility of trichomonas vaginalis isolates to secnidazole and metronidazole. Presented at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) 2017 Annual Meeting; August 10, 2017; Park City, Utah.|
|7.||Pentikis H. A review of the pharmacokinetic properties of SYM-1219, a single oral dose granule formulation containing 2 g of secnidazole, for the treatment of bacterial vaginosis. Presented at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) 2017 Annual Meeting; August 10, 2017. Park City, Utah.|
Payne S.C. et al. Evidence of African-American women’s frustrations with chronic, recurrent bacterial vaginosis. JAANP. 2010;22:101-108.
|9.||Bilardi J.E. et al. The burden of bacterial vaginosis: women’s experience of the physical, emotional, sexual and social impact of living with recurrent bacterial vaginosis. PlosOne. 2013; vol. 8, issue 9.|
|10.||Kardas P. Once-daily dosage secures better compliance with antibiotic therapy of respiratory tract infections than twice-daily dosage. Presented at the WONCA Europe 2002 Conference; June, 2002; London.|
Kardas P, Bishai W. Compliance in anti-infective medicine. Adv Stud Med. 2006; 6(7C): S652-S658.
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