Symbiomix announced positive results from the second pivotal trial of lead product candidate SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV). SYM-1219 is a potent, next-generation 5-nitroimidazole antibiotic anticipated to be the first and only single-dose oral treatment approved for BV. The company also announced a successful pre-NDA meeting with the U.S. Food & Drug Administration (FDA) to discuss the requirements for a New Drug Application (NDA) filing for SYM-1219. These milestones keep the product on track for a planned NDA filing in the fourth quarter of 2016. SYM-1219 has been designated a Qualified Infectious Disease Product (QIDP) by the FDA, which makes the product eligible for priority review and at least 10 years of market exclusivity.
The second pivotal trial of SYM-1219 for the treatment of BV was a Phase 3, randomized, double-blind, placebo-controlled trial in 189 women comparing a single, oral dose of SYM-1219 to a placebo in both infrequent sufferers and patients with recurrent BV. SYM-1219 achieved statistically and clinically significant results across all primary and secondary endpoints. These results were consistent with data from the first pivotal trial, which were presented at the 2015 Infectious Diseases Society for Obstetrics and Gynecology (IDSOG) Annual Meeting. The complete data from this Phase 3 study will be presented at an upcoming medical meeting.
“SYM-1219 is a true innovation for this common gynecological infection that can have serious health consequences,” commented Symbiomix Head of R&D and Chief Medical Officer Tom Beck, M.D. “We believe that this single-dose oral treatment will be the best option for women suffering with BV.”
Symbiomix also announced a successful pre-NDA meeting with the FDA. The company has now reached agreement with the agency on all requirements for an NDA filing.
“These milestones support our plan to file the SYM-1219 NDA in the fourth quarter of 2016,” said Robert Jacks, Symbiomix President and CFO. “We remain focused on commercial launch in 2017.”,/p>
SYM-1219 (secnidazole) is a potent, next-generation 5-nitroimidazole antibiotic with superior pharmacokinetic properties that enable efficacy with significantly less total drug exposure than first generation nitroimidazoles, leading to excellent safety, tolerability and adherence. Symbiomix has completed clinical development of SYM-1219 as a single-dose oral therapy for the treatment of BV and is on target for NDA filing in the fourth quarter of 2016 toward commercial launch in the second half of 2017.
SYM-1219 oral granules are anticipated to be the first and only single-dose oral therapy approved for BV. Because of its single-dose oral regimen, Symbiomix believes SYM-1219 will offer leading effectiveness and achieve better adherence to treatment than the current standard of care, leading to better patient outcomes. Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent. Further, 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.
SYM-1219 has been designated a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) for the treatment of BV. QIDP designation creates incentives for the development of new drugs intended to treat serious or life threatening infections. QIDP designation makes SYM-1219 eligible for certain benefits, including priority review, fast-track designation, and at least 10 years of market exclusivity.
About Bacterial Vaginosis (BV)
BV is the most common gynecological infection in the U.S. among women ages 15 to 44. Today more than four million women are treated in the US for BV annually.
The U.S. Centers for Disease Control and Prevention (CDC) has stated that BV can cause serious health risks, including the following:
- Increasing the risk of HIV transmission from an HIV infected partner;
- Increasing the risk of HIV transmission to an HIV-uninfected partner;
- In pregnant women, increasing the risk of delivering a baby too early; and,
- Increasing the risk of contracting sexually transmitted diseases, such as chlamydia and gonorrhea, which, if untreated, may lead to pelvic inflammatory disease and infertility.
BV disproportionately affects disadvantaged populations, including women of color, and may contribute to persistent disparities in women’s health outcomes.
Adherence with the current leading therapy for the treatment of BV has been shown to be only approximately 50 percent. More than 50 percent of women treated for BV have a recurrence within 12 months.