Bacterial vaginosis (BV) infects about 20 million women in the U.S. every year. As a result of contracting the gynecological disease, those women have an increased chance of contracting sexually transmitted diseases and spreading HIV.
“It’s really a big problem among populations that are underserved in this country,” said Robert Jacks, the president of Symbiomix Therapeutics,
Right now, the most-used drug is metronidazole. For full treatment, patients must take two doses of the antibiotic a day for seven days straight.
"For a long time it was considered a nuisance condition. A lot of the more recent literature is showing that BV actually causes very serious health risks in women."
But, underscoring the many issues with treating patients from underserved communities, people often don’t take the full dosage.
Symbiomix is working on a drug that’s designed to offer treatment in a single dose.
The company, which is based in Newark, N.J., and has seven employees working out of Emerging Technology Centers in Baltimore, is working to introduce a new antibiotic called SYM-1219.
With $19.5 million in backing from three venture capital firms and a primary focus on the BV drug, the late-stage company is working toward getting its product to market by 2017.
Last week, the company presented the results of Phase I trials of the treatment at the American Society of Clinical Pharmacology and Therapeutics conference in New Orleans. The trials showed the drug to be “safe and well-tolerated” in 28 healthy women. Another 54 healthy women took the BV treatment with a birth control pill, and the study found that the effects of the birth control were not altered by SYM-1219.
“The reason the Phase 1 data is significant is it really shows the long half-life of the drug,” Jacks said.
The company already completed Phase 2 trials, but has yet to release results. Phase 3 results, as well as a New Drug Application (NDA) to the U.S. Food and Drug Administration, would be required after that.
Along with business aims, the company’s urgency is motivated by public health. BV is the most common gynecological disease in the U.S.
While not an STD itself, the diseases it can lead to create even more urgency. A 2012 Johns Hopkins study found that black women in cities like Baltimore had a higher HIV infection rate than the national average, while earlier reports placed the city’s infection rates as a whole on par with numbers seen in Sub-Saharan Africa.
“For a long time it was considered a nuisance condition,” Jacks said. “A lot of the more recent literature is showing that BV actually causes very serious health risks in women.”
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