Evofem Biosciences Inc. (OTCMKTS:EVFM) announced updates on October 11, 2022, regarding the recently completed Phase 3 EVOGUARD clinical trial evaluating EVO100 for the prevention of chlamydia and gonorrhea infection in women. Unfortunately, the trial didn’t accomplish its endpoints.
Trading Data
On Tuesday, EVFM stock decreased 4.71% to $0.1639 with more than 956.04K shares, compared to its average volume of 8.91 million shares. The stock moved within a range of $0.1611 – 0.1800 after opening trade at $0.1720.
Evofem Reports Top-Line Results from Phase 3 EVOGUARD Clinical Trial Evaluating EVO100 for Prevention of Chlamydia and Gonorrhea Infection in Women
Saundra Pelletier, Chief Executive Officer of Evofem, has expressed her disappointment with the outcome. She said that 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. So the 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, is what led to these results.
The product safety profile was consistent with what has been observed in prior clinical trials, and only two women, comprising 0.1%, in the study discontinued due to adverse events. Clint Dart, VP, Biostatistics and Programming at Premier Research, believes the same. As the lead statistician on both the company’s EVOGUARD trial and the earlier Phase 2b/3 STI study, he is taken aback by the study results and is confident that COVID impacted the observed infection rates.
For now, the company continues to focus on fulfilling the unmet contraceptive need of millions of women with Phexxi but will discontinue further investment in the development of this STI clinical program due to lack of financial resources.
Key Quote
“We are disappointed that EVO100 did not achieve the desired outcome in this STI clinical trial, despite the data observed in our prior study,” said Saundra Pelletier, Chief Executive Officer of Evofem. “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. 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,” added Pelletier.
Technical Data
EVFM stock is trading below the 20-Day and 50-Day Moving averages of $0.21 and $0.36 respectively. Moreover, the stock is trading below the 200-Day moving average of $2.80.
