Symbiomix, a Newark, N.J.-based biopharmaceutical company aiming to bring innovative medicines to market for prevalent gynecological infections, announced in November presentation of data from studies of Solosec (secnidazole, also known as SYM-1219) oral granules at the 2016 American Association of Pharmaceutical Scientists (AAPS) Annual Meeting and Exposition in Denver. Solosec is described by the company as “a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties, and is anticipated to be the first and only single-dose oral therapy approved for bacterial vaginosis (BV).”
Symbiomix recently announced that it is accelerating plans for the commercial launch of Solosec, and the company is working towards a near-term submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). 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.
Robert Jacks, president and chief financial officer of Symbiomix, took a little time recently to discuss with DDNews the progress and characteristics of Solosec
DDNews: Your company describes Solosec as a “next-generation” 5-nitroimidazole antibiotic; what sets it apart, chemically and functionally, from previous antibiotics in that class?
Robert Jacks: Secnidazole is a new molecular entity with enhanced pharmacokinetics that provide prolonged antibiotic exposure for up to five days with a single oral dose. This allows for a complete regimen of secnidazole for the treatment of BV with only two grams of drug, given as a single oral dose, compared to seven grams of drug for the current CDC recommended regimen, dosed twice a day over seven days. In clinical studies, this has resulted in excellent efficacy as well as a very good safety and tolerability profile for Solosec. We also anticipate that giving an entire regimen in a single oral dose will lead to very good adherence to prescribed therapy, whereas adherence to the current CDC recommended regimen has been documented at only approximately 50 percent.
DDNews: How and why is that BV, being such a prevalent gynecological infection, also represents a significant unmet need, leading of course to the FDA granting both Qualified Infectious Disease Product designation and Fast Track designation to Solosec for the treatment of BV?
Jacks: 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. Currently, approximately 50 percent of women treated for BV will experience a recurrence within 12 months.
DDNews: The FDA New Drug Application was in your plans for the fourth quarter of 2016, but backtracking a bit, was there anything surprising or otherwise unexpected in the clinical trials results that got you to this point?
Jacks: No, Symbiomix has conducted a full preclinical and clinical development program to support the safety and efficacy of the product for NDA submission.
DDNews: Does Solosec have potential applications beyond BV? If so, which ones—and what are your future plans for Solosec if it does get approval for treating BV?
Jacks: Yes, Solosec has potential in a broad range of applications based on the spectrum of activity and enhanced pharmacokinetics of secnidazole. Symbiomix is actively pursuing a near-term indication for the treatment of trichomoniasis, also with a single oral dose. Symbiomix also is pursuing expansion of the label for the treatment of BV in pregnant women, and in postmenarchal adolescent girls. Symbiomix plans to announce other development applications in the future.
DDNews: I know you and the rest of the company are all proud of having moving from preclinical development to commercial launch plans in less than four years—to what do you attribute that?
Jacks: The preclinical and clinical program was well-defined in our interactions with FDA. The company had a very focused plan and managed the development program exceptionally well.
DDNews: Is there anything else you’d like to add about Solosec or any other therapeutics the company is working on?
Jacks: Women’s health, and specifically women’s health infections, is an area that has been devoid of innovation for too long. Symbiomix is proud to be a leading voice for women and an advocate for them to receive the healthcare they need and deserve. We believe that Solosec will have a very significant impact on women’s health, and will provide a springboard for Symbiomix to become the leading women’s health care company in the industry.