Symbiomix Therapeutics announces positive results from SYM-1219 Phase 1 clinical program

Symbiomix Therapeutics, LLCMar 4 2015

Symbiomix Therapeutics, a late-stage, privately held biopharmaceutical company developing innovative medicines for serious women's health infections, today announced results from its Phase 1 clinical program demonstrating that its lead product candidate, SYM-1219, was safe and well tolerated and had predictable pharmacokinetics (PK), and that contraceptive efficacy for birth control pills would not be altered by SYM-1219 administration.

These results will be presented on March 6^th at the annual meeting of the American Society of Clinical Pharmacology and Therapeutics (ASCPT), which takes place in New Orleans from today through March 7^th. Following are the details for the two posters presenting the study results:

• Poster (#42) is entitled, "A Phase 1 Study to Determine the Single Dose Safety and Pharmacokinetics of SYM-1219 (Secnidazole) in Healthy Female Volunteers."
• Poster (#92) is entitled, "A Phase 1, Open-label Study to Determine the Effect of SYM-1219 on the Pharmacokinetics of Ethinyl Estradiol (EE2) and Norethindrone (NET) in Healthy Female Volunteers."

Data from 28 healthy women demonstrated that single, oral, 1- and 2-gram doses of SYM-1219 were safe and well tolerated. The drug has a long half-life and there was consistent PK with low variability between the study subjects.

In addition, data were collected from 54 healthy women who took a single oral dose of SYM-1219 combined with a single dose of an ethinyl estradiol/norethindrone combination birth control pill. The data show that the contraceptive efficacy of birth control pills would not be altered by single-dose SYM-1219 administration.

"These data support the advancement of SYM-1219 into later-stage clinical trials to evaluate a single oral dose as a treatment for bacterial vaginosis (BV) and other women's health infections," said Helen S. Pentikis, Ph.D., Chief Scientific Officer of Symbiomix and first author on these abstracts. "Left untreated, BV can cause serious health risks to women. We believe that SYM-1219, as a single-dose oral regimen, will achieve significantly better adherence to treatment than current leading therapies, leading to better health outcomes."

Symbiomix is executing a rapid drug development program to gain U.S. Food & Drug Administration (FDA) approval for SYM-1219. The company recently completed a Phase 2 clinical trial in women with BV, and is targeting a New Drug Application (NDA) filing in mid-2016. If approved by the FDA, SYM-1219 would be the first single-dose, oral therapy for the treatment of BV, which currently impacts more than 20 million women in the United States each year.