Evofem Biosciences Inc (NASDAQ: EVFM) received fast track designation from the US FDA for its EVO100 to prevent gonorrhea in women.
The US FDA offers fast track designation to develop and expedite new therapies review and cure severe medical conditions.
Over 600,000 gonorrhea cases are reported in 2019, according to CDCP (Centers for Disease Control and Prevention) published report. It is the sixth consecutive year to report gonorrhea cases. FDA-approved drugs to prevent gonorrhea are not available in the market at present.
CMO of Evofem, Kelly Culwell, said FDA understood the need for products like EVO100 to eliminate sexually transmitted infections (STI), which are gaining resistance to antibiotics. Around 78 million sexually active females in the US are prone to STIs such as gonorrhea. If Evofem gets FDA approval for its EVO100, it could open a new chapter in the physician’s armamentarium to cure STIs.
EVO100 receives fast track designation to cure Chlamydia
The US FDA already granted fast track designation for EVO100 previously to prevent Chlamydia in females. Evofem also obtained QIDP (Qualified Infectious Disease Product) for this innovative formulation from FDA to prevent gonorrhea in females. The QIDP designation provides 5-year marketing exclusivity for Evofem’s EVO100.
Enrolls 1,730 females in Phase 3 clinical study
Evofem is enrolling 1,730 females in its phase 3 clinical trials (EVOGUARD) in the US to evaluate EVO100 to prevent gonorrhea and chlamydia in women. It will complete enrollment by the end of this year and expects to publish top-line trial results in mid-2022.
The positive data readout from the clinical trial allows the company to submit NDA to the US FDA for these potential indications by the end of next year. Evofem targets PDUFA date in Q3 2023.
Raises $46.6 million
Evofem closed its UPO (underwritten public offering) of 50 million shares and two-year warrants to acquire additional 50 million common shares. The underwriters also received a 30-day option to purchase additional 7.5 million common shares. At the end of closing the deal, the company gained net proceeds of $46.6 million.
The company will use the proceeds to continue the commercialization activities of Phexxi comprising digital channels, streaming, and advertising in TV. It will also use part of the proceeds for EVOGUARD.
