Mycovia Pharmaceuticals, Inc. today announced that Jiangsu Hengrui Pharmaceuticals Co., Ltd (“Hengrui”) received approval in June from the National Medical Products Administration for Oteseconazole Capsules, an azole antifungal, indicated for the treatment of severe vulvovaginal candidiasis (VVC).
- Oteseconazole Capsules were statistically superior to fluconazole, the current standard-of-care, - Oteseconazole Capsules were found to be safe and more effective than fluconazole - China commercial launch of Oteseconazole Capsules expected in late 2023 DURHAM, N.C., Aug. 21, 2023 /PRNewswire/ -- Mycovia Pharmaceuticals, Inc. (“Mycovia”), an emerging biopharmaceutical company, today announced that Jiangsu Hengrui Pharmaceuticals Co., Ltd (“Hengrui”) received approval in June from the National Medical Products Administration for Oteseconazole Capsules, an azole antifungal, indicated for the treatment of severe vulvovaginal candidiasis (VVC). Oteseconazole Capsules is contraindicated for females of reproductive potential, pregnant and lactating women, patients with known hypersensitivity to active ingredients, excipients and azoles. The approval of Oteseconazole Capsules for the treatment of severe VVC in China is an important milestone under Mycovia’s exclusive agreement with Hengrui to develop and commercialize oteseconazole in China, including Mainland China, Hong Kong, Macau and Taiwan, for the treatment or prevention of a range of fungal conditions. The approval of Oteseconazole Capsules was based on a Phase 3 study with 322 patients at 27 sites. The primary study endpoint was the proportion of subjects with therapeutic cure (defined as the absence of symptoms and signs of VVC with negative fungal culture candidiasis) at Day 28. In a randomized Phase 3 clinical study to evaluate the efficacy and safety of a two-day dosing regimen of SHR8008 (oteseconazole capsules) versus the current standard-of-care fluconazole in patients with severe VVC, therapeutic cure at Day 28 was significantly higher in the SHR8008 group than in the fluconazole group (66.88% vs 45.91%), p = 0.0002. Mycological cure at Day 28 was higher in the SHR8008 group than in the fluconazole group (82.50% vs 59.12%), p < 0.0001. Therapeutic cure and mycological cure at Day 14 were also statistically superior for subjects receiving SHR8008 compared to those receiving fluconazole. Reported adverse events were similar between treatment groups. “We celebrate and congratulate our partner, Hengrui, on receiving its approval for Oteseconazole Capsules for the treatment of severe VVC,” said Patrick Jordan, CEO of Mycovia and Managing Partner at NovaQuest Capital Management. “The disease burden in China is significant and the approval of Oteseconazole Capsules gives another treatment option for those women suffering with VVC.” Vulvovaginal candidiasis is an exceedingly common mucosal infection usually caused by Candida albicans but can occasionally be caused by other Candida species or yeasts. Typical symptoms include vulvovaginal itching, irritation, burning, soreness, fissuring, redness, vaginal discharge, and dyspareunia. Approximately 70% to 75% of women in all strata of the society will experience at least one episode during their lifetime. Oteseconazole is designed to selectively inhibit fungal CYP51, which is required for fungal cell wall integrity, and this interaction is also toxic to fungi, resulting in the inhibition of fungal growth. Due to its chemical structure, oteseconazole has a lower affinity for human CYP enzymes as compared to fungal CYP enzymes. In April 2022, the U.S. Food and Drug Administration (FDA) approved VIVJOA® (oteseconazole) Capsules, as the first medication for Recurrent Vulvovaginal Candidiasis (chronic yeast infection). About Recurrent Vulvovaginal Candidiasis About VIVJOA® Please click here for full Prescribing Information. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VIVJOA is contraindicated in pregnant and lactating women. VIVJOA is contraindicated in patients with known hypersensitivity to oteseconazole. WARNINGS AND PRECAUTIONS ADVERSE REACTIONS DRUG INTERACTIONS Please see full Prescribing Information and Patient Information. To report SUSPECTED ADVERSE REACTIONS, contact Mycovia Pharmaceuticals, Inc. at 1-855-299-0637 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. About Mycovia Pharmaceuticals, Inc. Mycovia also recognizes a tremendous potential for its oral fungal inhibitors and a growing need to treat a range of multi-drug resistant fungal pathogens. For more information, please visit www.mycovia.com. About Jiangsu Hengrui Pharmaceuticals Co., Ltd. 1. https://torreya.com/publications/pharma-1000-report-torreya-2021-11-08.pdf; page 49 and 56. 2. https://www.pharmexec.com/view/2022-pharm-exec-top-50-companies; page 24 About NovaQuest Capital Management View original content to download multimedia:https://www.prnewswire.com/news-releases/mycovia-pharmaceuticals-inc-announces-partner-jiangsu-hengrui-pharmaceuticals-co-ltds-approval-of-oteseconazole-capsules-for-the-treatment-of-severe-vulvovaginal-candidiasis-vvc-in-china-301904626.html SOURCE Mycovia Pharmaceuticals, Inc. |