The FDA has lifted its 19-month clinical hold on vaginal yeast infection drug Brexafemme (ibrexafungerp), according to the treatment's developer Scynexis.
In its first-quarter report, the Jersey City, N.J., company revealed that the U.S. regulator lifted the suspension late last month.
In September of 2023, a phase 3 trial of ibrexafungerp was put on hold shortly after Scynexis issued a voluntary recall of Brexafemme tablets due to the potential for cross-contamination.
The concern stemmed from a review by GSK, shortly after the British pharma giant entered a licensing deal with Scynexis in early 2023. GSK found that the equipment used to produce Brexafemme also was used to manufacture a beta-lactam substance. Beta-lactam compounds can trigger allergic reactions in some individuals.
“The lifting of the clinical hold for ibrexafungerp was an important achievement for our company,” David Angulo, M.D., Scynexis’ CEO, said in the company's quarterly release.
Angulo added that—despite the intention of GSK to terminate the delayed study—Scynexis is “moving forward” with the MARIO trial, which is investigating Brexafemme as a treatment for invasive candidiasis. The company plans to have subjects enrolled in the “coming weeks.”
Scynexis also said in its release that it “does not believe that GSK currently has the right to unilaterally terminate the MARIO study under the license agreement.”
"We continue to work with Scynexis to commercialize Brexafemme," a GSK spokesperson said. "With rates of resistance to other antifungal treatments rising, Brexafemme addresses a clear unmet need for new oral treatments and is an important asset of our growing anti-infectives portfolio."
When Brexafemme was approved in 2021 for vulvovaginal candidiasis (VVC), it brought a new class of antifungal drugs to the indication, which had few attractive treatment options.
Some analysts projected it had blockbuster potential, but entering the commercial realm was a challenge for Scynexis, which cut 40% of its staff in 2022.
After reporting sales of just $5 million for 2022, Scynexis struck the licensing deal with GSK in March of 2023, receiving $90 million up front with $503 million available in milestones. The deal was a lifeline of sorts for Scynexis, which was founded in 1999.
Last year, GSK amended its deal with Scynexis, reducing the potential milestone payments.