Symbiomix Therapeutics Accelerates Commercial Launch Preparation for Solosec™ Following Presentation of Results from Second Pivotal Trial at IDSOG

NEWARK,N.J., Aug. 17, 2016 /PRNewswire/ -- Symbiomix today announced it is accelerating plans for the commercial launch of Solosec™ (secnidazole) oral granules following the presentation of clinical results from the second pivotal trial for the treatment of bacterial vaginosis (BV) with the hiring of Taunia Markvicka, PharmD, MBA, as Chief Commercial Officer. Symbiomix had a significant presence at the Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting in Annapolis, Maryland this past weekend with both the oral data presentation and sponsorship of a panel discussion on emerging diagnosis and treatment recommendations for BV. In addition, the company announced that the U.S. Food and Drug Administration (FDA) issued conditional acceptance of the proprietary name Solosec™. Solosec™ was previously known as SYM-1219.

Symbiomix has now completed clinical development of Solosec™ as a single oral dose therapy for the treatment of BV and is on target to submit a New Drug Application (NDA) to the FDA in the fourth quarter of 2016 in support of a planned commercial launch in the second half of 2017. 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.

"Symbiomix has brought a potential game-changing product from preclinical development to the doorstep of commercial launch in less than four years," commented Robert Jacks, President and CFO. "The milestones announced today mark a turning point for Symbiomix from a drug development company to a commercially focused enterprise."

Solosec™ has now achieved high statistical significance across all primary and secondary endpoints (p-value less than 0.001) in two pivotal trials for the treatment of BV. The Phase 3 trial results presented at IDSOG this year were from study 301, a randomized, double-blind, placebo-controlled study in 189 women comparing a single, oral dose of Solosec™ to a placebo for the treatment of BV at 21 clinical and academic centers in the United States. Study 301 enrolled both infrequent BV sufferers and women with recurrent BV.

New Chief Commercial Officer Dr. Markvicka joins Symbiomix from Pacira Pharmaceuticals where she was most recently Senior Vice President, Chief Commercial Officer, and Commercial Strategy. At Pacira, she led a successful acute care launch for EXPAREL® and supported the company's IPO as the commercial management team leader. She has led commercial strategy and execution across several categories including women's health, cardiovascular, and dermatology. Dr. Markvicka, also serves on the Board of Directors for CorMedix.

"Few people recognize the scale of the unmet need in the treatment of BV," commented Dr. Markvicka. "BV is even more prevalent than vaginal candida (yeast) infection, puts infected women at risk of serious health problems such as HIV transmission and pre-term birth, and has a major impact on work productivity and quality of life. Innovation in the treatment of this important women's health infection is long overdue. We plan to bring BV out of the shadows where millions of women are needlessly suffering in silence."

About Solosec™

Solosec™ 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.

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 [3]. More than 50 percent of women treated for BV have a recurrence within 12 months [4].

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 [2].

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 [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 [10]. 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 [11].

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.

REFERENCES

1. 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.
2. http://www.cdc.gov/std/bv/stdfact-bacterial-vaginosis.htm
3. IMS Health, 2014
4. 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.
5.  http://www.cdc.gov/std/bv/stats.htm
6. Fiscella, K. (1996). "Racial disparities in preterm births. The role of urogenital infections." Public Health Rep 111(2): 104-113.
7. Payne et al. (2010). "Evidence of African-American women's frustrations with chronic, recurrent bacterial vaginosis." Jn AANP 22(2010) 101-108.
8. 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.
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.
10. 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.
11. Kardas, P., Bishai, W., (2006). "Compliance in anti-infective medicine." Adv Stud Med 2006; 6(7C):S652:S658.

SOURCE Symbiomix Therapeutics, LLC

Related Links

http://www.symbiomix.com