Evofem’s approved birth control gel flops PhIII for STI prevention, early 2023 filing plans ditched

A biotech with an approved non-hormonal birth control gel had hoped it would be at the FDA’s doorsteps in early 2023 to request a label expansion into STI prevention.

But those ambitions were squashed Wednesday morning as Evofem said its gel, marketed as Phexxi for contraceptive use, failed a Phase III study testing it as a way to stop the spread of chlamydia and gonorrhea infection.

The company did not release the topline data. Asked for the data, chief commercial officer Katherine Atkinson told Endpoints News in an emailed statement: “There was insufficient separation between the active and the placebo arm. A full report on the data will be available via the FDA in the near future.”

CEO Saundra Pelletier, trial investigator Brandi Howard and study statistician Clint Dart all blamed the loss on Covid-19’s impact on infection rates and patients’ “risk behavior” in a press release.

With that, Evofem is ending further investment in the STI clinical program “due to financial resources,” the San Diego biotech said in a statement.

“The impact of the public health response to the COVID pandemic included universal recommendations for social distancing, individual and household quarantines, and clinic visits for health emergencies only,” Pelletier said in prepared remarks. “We believe changes in clinical site operations, subject behavior and actions including deviations from following the clinical study protocol requirements related to STI acquisition, detection, and prevention contributed to this outcome.”

The study began in October 2020 and wrapped up in July of this year. More than 1,700 patients were enrolled in the US study, which compared placebo to 5 g of the vaginal gel, known investigationally as EVO100 and comprised of lactic acid, citric acid and potassium bitartrate.

Evofem had planned to ask for FDA approval in the first quarter of next year, according to its website. Pelletier previously told Endpoints that the company would try to keep its ambassador and TV ad spokesperson, Annie Murphy of “Schitt’s Creek” fame, past the September 2022 contract end-date “because we are then going to potentially have the prevention of chlamydia and gonorrhea added to the Phexxi label.”

The late-stage roadblock represents another setback for the penny stock company, which has faced uphill battles in getting the contraceptive on the market, delisting from Nasdaq in August and switching over to the OTC Pink Open Market and then OTCQB last week. In September, the company restructured its debt.

Read More