VISEN Pharmaceuticals Announced the Successful Completion of Patient Enrollment in Phase 3 Study for TransCon PTH

June 17 2022, SHANGHAI VISEN Pharmaceuticals, an innovative biopharmaceutical company focused on endocrine diseases, announced that it has successfully completed the enrollment of patients on June 16, 2022 in a phase 3 China clinical trial (PaTHway China Trial) for its innovative investigational new drug TransCon PTH (palopegteriparatide) that evaluates the efficacy and safety for treating Hypoparathyroidism(HP). PaTHway China Trial is a randomized, double-blind, placebo-controlled, parallel, multi-center phase 3 study to assess the potential of TransCon PTH as a hormone replacement therapy. The primary endpoints of the study include evaluating the safety, tolerability, and efficacy of once-daily subcutaneous injection of TransCon PTH in adults with HP. The aim is to enable patients to have serum calcium (sCa) within the normal range and, in the meanwhile, independent from conventional therapy. It obtained the investigational new drug (IND) approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) on May 31, 2021, to initiate clinical research in China. HP is the last endocrinedeficiency state, where hormone replacement so far has not been established as standard management. Conventional therapy with calcium supplements and active vitamin D could not fully control the progression of the disease and could lead to risks of long-term complications, such as chronic kidney diseases. The once-daily subcutaneous injection of TransCon PTH enables sustained exposure within normal physiological range of PTH concentrations, namely mimic continuous PTH infusion. It’s expected to become the first hormone replacement treatment targeting HP in China. Pony LU, CEO and Board Member of VISEN Pharmaceuticals, said: ” HP patients often require lifelong treatment, which seriously impact their quality of life. Currently the conventional therapy of HP only reduces short-term symptoms, and is not able to address the underlying cause of HP.” “Completing the patient enrollment of the phase 3 trial means we have moved a step closer towards the success of our research efforts for China’s first hormone replacement therapy targeting HP. We look forward to bringing new treatment options to Chinese HP patients as soon as possible, so that Chinese endocrine patients can have better treatment processes and outcomes results in living better lives." It’s also noteworthy that the key secondary efficacy endpoint in PaTHway China include two patient-reported outcomes (PROs), which are “Hypoparathyroidism Patient Experience Scale (HPES)” and “36 Item Short Form Health Survey (SF-36)” reported by HP patients receiving TransCon PTH. Due to the lack of patient reported data regarding Chinese HP patients’ quality of life, employment status and the disease’ impact on their daily work, the PaTHway China trial will also assess their life quality through the patient-reported outcome measures. VISEN Pharmaceuticals also signed a strategic cooperation agreement with the Clinical Research Institute of Peking University in 2021 to launch PaTHway R, China's first large-scale HP registry study program to complement the lack of data in the field of hypoparathyroidism in the country. It's aimed at better understanding the status of treatment of hypoparathyroidism, the dangers and burden caused by the disease, and to offer guidance for further medical education and treatment strategies. ******************************* About VISEN Pharmaceuticals VISEN is an innovative biopharmaceutical company focused on endocrine diseases. We are dedicated to providing innovative therapies and compassionate, patient-centric care, because we believe that achieving better treatment processes and outcomes results in living better lives. Putting patients' need first, VISEN is committed to providing first-in-class or best-in-class products and treatments for endocrine diseases. Our therapeutic areas cover endocrine diseases in adults and children, and rare endocrine diseases. VISEN comprises seasoned professionals with multinational pharmaceutical experiences and leverages cutting-edge technologies and leading resources across the world. We are focused on the Chinese market, and have established offices in Shanghai, Beijing, Hong Kong and Taipei. We have also launched our Greater China R&D and Manufacturing Campus in Suzhou to enhance R&D, manufacturing and commercialization efforts. Our goal is to enable Chinese endocrine patients to benefit from the world's most advanced and reliable treatment solutions earlier. For more information, please visit our website: http://www.visenpharma.com/ Media Contact VISEN Pharmaceuticals [email protected]

The release as fetched from its publisher. visenpharma.com ↗