In the little more than two years since its launch, Symbiomix Therapeutics has successfully navigated a midstage study for a sole-asset antibiotic, positioning it for a Phase III start in Q2. And now it's ready to jump out of stealth mode as it prepares for a make-or-break move for an anti-infective that has been in use for years--just not in the U.S.
Operating quietly with some deep-pocketed support at two A-list venture groups, Orbimed and Fidelity Biosciences, the company president says Newark, NJ-based Symbiomix snagged U.S. rights to an antibiotic that's already gone generic in a roster of other nations but was never introduced here. And now the last tranche of its $41 million A round is in place to take Symbiomix through a confirmatory pivotal study by the end of this year and on to a prospective new drug application at the FDA in the middle of next year.
HBM Partners stepped in alongside Orbimed and Fidelity as a new investor last year.
Symbiomix was founded on the basis of SYM-1219, otherwise known as secnidazole, a last-generation, 5-nitroimidazole antibiotic that has a long track record in the clinic. A simple Google search is enough to find that a single dose of the drug spurred a high cure rate among women with bacterial vaginosis (BV) way back in 2004. The antibiotic is sold as Flagentyl in countries like the Congo and Vietnam. It also has a close structural resemblance to metronidazole--sold as Flagyl to treat bacterial infections--which is one of the standard antibiotics used for BV.
|Symbiomix President Robert Jacks|
What makes secnidazole particularly attractive, says Symbiomix President and co-founder Robert Jacks, is that a single oral dose has been shown to be effective against BV in a high percentage of cases, making it a superior drug to metronidazole, which requires multiple dosing and therefore has only a relatively low adherence rate among patients. A study in 2010 established that the antibiotic was noninferior to metronidazole, he adds. (Symbiomix says it's holding its Phase II data for a future scientific conference.) That makes their drug a likely favorite among practitioners treating the common gynecological infection in the U.S., affecting "almost 30 percent of women of child-bearing age each year."
According to Jacks, John Gregg, now CEO at BalinBac Therapeutics in New York, initially helmed the company. But he left in 2013, says Jacks, for other opportunities. Asked why he left, Jacks responded that Gregg might be the best person to answer that.
Jacks also isn't saying which manufacturer they in-licensed the antibiotic from.
Symbiomix and its backers say that for whatever reason, even though the antibiotic was approved and in use in a number of countries, it never made its way to the FDA. That gives the startup biotech a clean shot not just at a near-term approval, but armed with a new designation as a Qualified Infectious Disease Product, there's an extra 5 years of market exclusivity on the table, part of the U.S. government's new list of incentives to encourage developers to develop new antibiotics.
In a normal world, the company and its venture backers would soon look to sell their sole asset after a relatively modest investment and move on. Jacks, though, says that's not the current plan.
"We're planning to go ahead and commercialize the drug ourselves," says Jacks. "However, we've received already quite a bit of strategic interest," he adds, leaving the 10-person company open to all possibilities.
No matter how preferential it may be on the adherence side, selling a drug like this as a branded treatment against a long-established generic could run into a wall of opposition from payers, who appear increasingly willing to trade less convenient dosing for patients in return for lower prices.
- here's the release