Hansoh Pharma's High-Value In-Licensed Broad-Spectrum Antifungal Ibrexafungerp Granted Approval for Phase III Clinical Trial in China

Source: PharmaCube Info

Author: Sunshine

On December 16, Hansoh Pharma announced that the Phase III clinical trial of Ibrexafungerp tablets had been approved by the CDE for the treatment of vulvovaginal candidiasis (VVC).

In February 2021, Hansoh Pharma signed an agreement with Scynexis to obtain the exclusive license for the research, development, and commercialization of ibrexafungerp in China (including Hong Kong, Macao, and Taiwan). Hansoh Pharma also paid Scynexis an upfront payment of US$10 million, with potential milestone payments and royalties.

Vaginal Yeast Infection is a type of fungal infection, with symptoms including vulvar itching and burning pain, significantly affecting patients' lives. Globally, about 70%-75% of women experience at least one vaginal yeast infection in their lifetime, but there has been no innovative therapy in this field since 1990.

In June 2021, ibrexafungerp (brand name: Brexafemme) was approved by the U.S. FDA for marketing to treat vulvovaginal candidiasis, becoming the first newly approved antifungal class in over two decades and the first and only non-azole therapy for vaginal yeast infections. Previously, ibrexafungerp had received FDA Qualified Infectious Disease Product (QIDP) designation, Fast Track designation, and Orphan Drug designation.

Ibrexafungerp is a first-in-class, novel triterpenoid-structured glycogen synthase inhibitor with a completely new mechanism of action. It exhibits broad-spectrum antifungal activity and can be used to treat infections caused by drug-resistant strains, including azole and echinocandin resistance. The drug has been proven to effectively inhibit glycogen synthase activity, fully leveraging the therapeutic advantages of both intravenous and oral formulations.

Currently, Ibrexafungerp is in the late-stage clinical development for multiple indications, including hospital-acquired infections mainly caused by fungi such as Candida (including Candida auris) and Aspergillus.