Brexafemme Ibrexafungerp tablets are effective in treating vaginal yeast infections

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Today Scynexis announced the publication of its Phase 3 study VANISH-306 in the International Journal of Obstetrics and Gynecology (BJOG). The results show that oral ibrexafungerp is safe and effective for treating vulvovaginal candidiasis (VVC; vaginal yeast infection) when compared to placebo.

Patients who received oral ibrexafungerp for one day had significantly higher rates of clinical healing, mycological eradication, and clinical improvement than those who received placebo.

On day 25, 73.9% of patients treated with ibrexafungerp achieved complete elimination of signs and symptoms.

David Angulo, MD, Scynexis Chief Medical Officer, said, “Ibrexafungerp is a premier one-day oral therapy that blocks glucan synthase, an enzyme essential in maintaining the cell wall of fungi that has been shown to have antifungal activity in vitro several different candidateSpecies strains, including those resistant to echinocandin and azole. “

VANISH-306 was a global, multicenter, randomized, double-blind, placebo-controlled study investigating oral ibrexafungerp in women 12 years of age and older with VVC. At the test-of-cure (TOC) visit on day 10, the patients who received ibrexafungerp had statistically significant clinical cure rates compared to the placebo group (63.3% [119/188] vs. 44.0% [37/84]). “Clinical cure” was defined as complete resolution of vulvovaginal signs and symptoms without the need for further antifungal treatment or topical medication prior to or at the day 10 TOC visit. The TOC visit also showed higher rates for ibrexafungerp than placebo for mycological eradication (58.5% [110/188] compared to 29.8% [25/84]) and clinical improvement (72.3% [136/188] vs. 54.8% [46/84]).

Ibrexafungerp demonstrated statistical superiority over placebo on the primary endpoint and on the vital secondary endpoints. It was generally well tolerated, with the majority of side effects reported being mainly gastrointestinal and mild to moderate side effects.

The successful VANISH Phase 3 clinical trials (VANISH-303 and VANISH-306) resulted in the US Food and Drug Administration (FDA) approving Brexafemme Ibrexafungerp tablets in June 2021.

Brexafemme is a triterpenoid antifungal drug used to treat adult and postmenarchal pediatric women with VVC. The recommended dose of Brexafemme is 2 150 mg ibrexafungerp tablets twice a day for one day (total dose 600 mg).

“We believe that the publication of the results of our VANISH-306 trial will provide clinicians with valuable insight into the efficacy and safety of this breakthrough treatment as a potent therapeutic option for potentially millions of women across the country,” said Angulo.


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