Startup Symbiomix Grabs $41 Million to Fund Trial for a Newish Old Antibiotic
May 6, 2015
By Riley McDermid, BioSpace.com Breaking News Sr. Editor
Newark, NJ-based Symbiomix is finally hitting the big time, announcing Wednesday that it has snagged $41 million in a Series A round from marquee-name investors, while successfully navigating a Phase II trial of its main drug candidate. That money will be used to fund a Phase III trial as soon as the second quarter, said the company.
Investors included OrbiMed, Fidelity BioSciences, HBM Partners and Square 1 Bank.
It now says that antibiotic, SYM-1219 for the treatment of bacterial vaginosis, will roll right into a Phase III trial by the second quarter of 2015.
“Based on discussions with the U.S. Food and Drug Administration (FDA) at an End-of-Phase 2 meeting, the Company now is planning to submit the Phase 2 trial as one of two pivotal studies for a New Drug Application (NDA) filing in 2016,” the company said in a statement.
The FDA recently designated SYM-1219 as a Qualified Infectious Disease Product (QIDP). The single-dose product contains secnidazole, an antibiotic with favorable pharmacokinetics that facilitate administration as a single-dose oral therapy.
Symbiomix said Wednesday that BV is the “most prevalent gynecological infection” in the U.S., affecting almost 30 percent of women of child-bearing age each year, and adherence to current drugs are only effective in approximately 50 percent of patients.
"There has been little innovation in the treatment of serious women's health infections for several decades," said Symbiomix Chief Medical Officer Carol J. Braun. "The results of our Phase 2 study demonstrate the potential of SYM-1219 to be the first effective, oral, single-dose treatment for BV. We believe that SYM-1219 can improve treatment outcomes for this infection that affects more than 20 million women in the U.S. each year."
That’s a lot of progress for a two-year-old company that has tried to fly below the radar for its first nascent years.
"The Symbiomix team has made great progress in a short amount of time to advance our lead drug candidate, SYM-1219, as a potential treatment for BV," said Robert Jacks, president and chief financial officer of Symbiomix, in a statement. "The achievement of these milestones keeps the program on track for NDA submission in mid-2016."
Will Hungry Pfizer Make a Play for Struggling GlaxoSmithKline?
Almost a year after its $119 billion offer for AstraZeneca PLC fell apart in the face of massive opposition from regulators and internal dissent, global drugmaker Pfizer Inc. is once again being floated as a potential buyer of another marquee-name British pharmaceutical company: GlaxoSmithKline . We at BioSpace want to know your thoughts: With cash to burn, will Pfizer go hunting for Glaxo?