Oteseconazole

- VIVJOA demonstrated statistically significant and clinically meaningful superiority to fluconazole, the current standard-of-care, in treating women with severe VVC - Treatment-emergent adverse events were similar between patients treated either with VIVJOA or fluconazole DURHAM, N.C., Jan. 31, 2024 /PRNewswire/ -- Mycovia Pharmaceuticals, Inc. ("Mycovia"), an emerging biopharmaceutical company, today announced that its partner Jiangsu Hengrui Pharmaceuticals Co., Ltd ("Hengrui") has published its phase 3 study evaluating the efficacy and safety of VIVJOA® (oteseconazole) capsules versus fluconazole in the treatment of severe vulvovaginal candidiasis (VVC) in Chinese women in the journal Antimicrobial Agents and Chemotherapy. The peer-reviewed article describes the results of a multi-center, randomized, double-blinded, phase 3 study designed to evaluate efficacy and safety of VIVJOA as a two-day dosing regimen versus fluconazole in women with severe VVC. The authors concluded that VIVJOA was statistically superior to fluconazole in treating severe VVC. At Day 28, 66.88% of patients treated with VIVJOA had therapeutic cure (absence of signs and symptoms of VVC and negative culture of Candida species), compared to 45.91% of patients treated with fluconazole (p = 0.0002). Mycological cure (negative culture of Candida species) and clinical cure (absence of signs and symptoms of VVC) at Day 28 was higher in the patients treated with VIVJOA compared to patients treated with fluconazole (82.50% vs. 59.12%, p < 0.0001 and 71.25% vs. 55.97%, p = 0.0046, respectively). At Day 14, therapeutic cure and mycological cure were superior for patients treated with VIVJOA compared to those treated with fluconazole (52.50% vs. 38.36%, p = 0.0112 and 81.88% vs. 66.67%, p = 0.0019, respectively. The rates of patients who had at least one treatment-emergent adverse event (TEAE) were similar in both groups (51.3% of patients in the VIVJOA group and 42.9% of patients in the fluconazole group). Of the patients experiencing a TEAE, similar rates of treatment-related adverse events were reported (21.9% in the VIVJOA group and 19.9% in the fluconazole group). The most commonly reported TEAEs were urinary tract infection and bacterial vulvovaginitis. "These clinical data describe the first head-to-head study of VIVJOA versus fluconazole, considered to be the standard-of-care for treating VVC for over 30 years. Following its recent approval in China, VIVJOA offers health care providers and their appropriate patients with a novel, safe and efficacious oral treatment option," said Stephen Brand PhD, Chief Development Officer at Mycovia. "The results also expand on available clinical susceptibility data by demonstrating potent MIC activity of oteseconazole against wild-type and resistant Candida albicans isolates from this patient population, in addition to clinical isolates resistant to fluconazole, including Candida glabrata." 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). In June 2023, VIVJOA received approval in China from the National Medical Products Administration and is indicated for the treatment of severe VVC. About VIVJOA® VIVJOA® (oteseconazole) is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. VIVJOA is the first FDA-approved medication that provides sustained efficacy demonstrated by significant long-term reduction of RVVC recurrence through 50 weeks versus comparators. Oteseconazole is designed to inhibit fungal CYP51, which is required for fungal cell wall integrity, and this selective 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. The FDA approved VIVJOA based upon the positive results from three phase 3 clinical trials of oteseconazole – two global VIOLET studies and one U.S.-focused ultraVIOLET study, including 875 patients at 232 sites across 11 countries. Please click here for full Prescribing Information. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VIVJOA is contraindicated in females of reproductive potential. Females who are NOT of reproductive potential are defined as: persons who are biological females who are postmenopausal or have another reason for permanent infertility (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy). VIVJOA is contraindicated in pregnant and lactating women. VIVJOA is contraindicated in patients with known hypersensitivity to oteseconazole. WARNINGS AND PRECAUTIONS Based on animal studies, VIVJOA may cause fetal harm. The drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate mitigation of the embryofetal toxicity risks. Advise patients that VIVJOA is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant. ADVERSE REACTIONS The most frequently reported adverse reactions among VIVJOA-treated patients in clinical studies included headache (7.4%) and nausea (3.6%). DRUG INTERACTIONS VIVJOA is a Breast Cancer Resistance Protein (BCRP) inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates, which may increase the risk of adverse reactions associated with these drugs. 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 . About Mycovia Pharmaceuticals, Inc. Mycovia Pharmaceuticals, Inc. is an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies. VIVJOA® (oteseconazole) capsules, the first FDA-approved product for Mycovia, is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. Oteseconazole received FDA Qualified Infectious Disease Product and Fast-Track designations to become the first FDA-approved therapy for RVVC. In 2019, Mycovia licensed oteseconazole to Jiangsu Hengrui Pharmaceuticals Co., Ltd., to develop and commercialize oteseconazole in China, including mainland China, Hong Kong, Macau and Taiwan. 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 . About Jiangsu Hengrui Pharmaceuticals Co., Ltd. Hengrui Pharma is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui Pharma ranked 21st among the top 1,000 global pharmaceutical companies in 2021.1 Hengrui Pharma has been on the Pharma Exec's annual listing of the top global pharmaceutical companies for the fourth consecutive year, rising from the 47th in 2019 to the 32nd in 2021.2

- Oteseconazole Capsules were statistically superior to fluconazole, the current standard-of-care, in treating women with severe VVC - 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 RVVC is a debilitating, chronic infectious condition that affects 138 million women worldwide each year. RVVC, also known as chronic yeast infection, is a distinct condition from vulvovaginal candidiasis (VVC) and defined by the Centers for Disease Control and Prevention as three or more symptomatic acute episodes of yeast infection in 12 months. Primary symptoms include vaginal itching, burning, irritation and inflammation. Some women may experience abnormal vaginal discharge and painful sexual intercourse or urination, causing variable but often severe discomfort and pain. About VIVJOA® VIVJOA® (oteseconazole) is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. VIVJOA is the first FDA-approved medication that provides sustained efficacy demonstrated by significant long-term reduction of RVVC recurrence through 50 weeks versus comparators. Oteseconazole is designed to inhibit fungal CYP51, which is required for fungal cell wall integrity, and this selective 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. The FDA approved VIVJOA based upon the positive results from three phase 3 clinical trials of oteseconazole – two global VIOLET studies and one U.S.-focused ultraVIOLET study, including 875 patients at 232 sites across 11 countries. Please click here for full Prescribing Information. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS VIVJOA is contraindicated in females of reproductive potential. Females who are NOT of reproductive potential are defined as: persons who are biological females who are postmenopausal or have another reason for permanent infertility (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy). VIVJOA is contraindicated in pregnant and lactating women. VIVJOA is contraindicated in patients with known hypersensitivity to oteseconazole. WARNINGS AND PRECAUTIONS Based on animal studies, VIVJOA may cause fetal harm. The drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate mitigation of the embryo-fetal toxicity risks. Advise patients that VIVJOA is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant. ADVERSE REACTIONS The most frequently reported adverse reactions among VIVJOA-treated patients in clinical studies included headache (7.4%) and nausea (3.6%). DRUG INTERACTIONS VIVJOA is a Breast Cancer Resistance Protein (BCRP) inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates, which may increase the risk of adverse reactions associated with these drugs. 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 . About Mycovia Pharmaceuticals, Inc. Mycovia Pharmaceuticals, Inc. is an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies. VIVJOA® (oteseconazole) capsules, the first FDA-approved product for Mycovia, is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. Oteseconazole received FDA Qualified Infectious Disease Product and Fast-Track designations to become the first FDA-approved therapy for RVVC. In 2019, Mycovia licensed oteseconazole to Jiangsu Hengrui Pharmaceuticals Co., Ltd., to develop and commercialize oteseconazole in China, including mainland China, Hong Kong, Macau and Taiwan. 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 . About Jiangsu Hengrui Pharmaceuticals Co., Ltd. Hengrui Pharma is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui Pharma ranked 21st among the top 1,000 global pharmaceutical companies in 2021.1 Hengrui Pharma has been on the Pharma Exec's annual listing of the top global pharmaceutical companies for the fourth consecutive year, rising from the 47th in 2019 to the 32nd in 2021.2 1. ; page 49 and 56. 2. ; page 24 About NovaQuest Capital Management Founded by a team of accomplished industry professionals in 2010, NovaQuest Capital Management is a premier biopharma and life sciences investment firm. NovaQuest pioneered a Product Finance solution for the industry, providing at-risk, nondilutive funding that enables partner companies to advance pivotal clinical trials, launch new brands, license products, and acquire accretive products or companies. NovaQuest has invested in scores of biopharmaceutical assets across therapeutic areas with a clinical success rate significantly higher than the industry average. NovaQuest is actively evaluating and investing into global opportunities with financing needs that range from $30-100 million. For more information, please visit . SOURCE Mycovia Pharmaceuticals, Inc.