SHANGHAI, CHINA, April. 1, 2022– Zhongze Therapeutics, a clinical stage biotech company focused on the discovery, development and commercialization of innovative and transformative therapies for both psychiatric and neurological disorders announced today the successful completion of the first-in-human dose escalating study of ZZ6398 (SIPI6398) in healthy volunteers.
“We are thrilled that top line results indicate ZZ6398 is safe and well tolerated in healthy volunteers with better than expected PK parameters which will be presented in future international scientific conferences” commented Xianbo Zhou, M.D. and Ph.D., Co-Founder and CEO of ZHONGZE. “These results place us in a great position to rapidly progress ZZ6398 to address the huge unmet medical needs of schizophrenia patients, especially the cognitive impairment symptoms. We are grateful for the contribution of the healthy volunteers, our collaborators, especially our PI Dr. Gang Wang and his wonderfully staff and our CRO Giant Med-Pharma Service Group to accomplish this quickly despite the COVID-19 interference.”
“It’s great that ZZ6398 is safe and well tolerated in heathy volunteers. Given the unique mechanism of action of ZZ6398 with potential to address the cognitive symptoms while simultaneously addressing the positive and negative symptoms, I am very excited and look forward to leading the future clinical development of ZZ6398 that has the potential to transform the clinical management of schizophrenia patients” commented Principal Investigator Gang Wang, M.D. and Ph.D., President of Anding Hospital in Beijing.
ZZ6398 is an investigational new drug for schizophrenia developed by ZHONGZE. ZZ6398 is the first pan-antagonist of D2, D3, 5-HT1A and 5-HT2A receptors designed especially for the treatment of cognitive impairment associated with schizophrenia through fine-tuning the D2/D3 selectivity and 5-HT1A antagonism while simultaneously addressing the positive and negative symptoms. Cognitive impairment associated with schizophrenia is an unmet medical need with no approved therapy. The First-In-Man dose of ZZ6398 was administered on Sept. 12, 2021. In preclinical studies, ZZ6398 demonstrated efficacies in animal models of positive, negative and cognitive symptoms of schizophrenia.
Zhongze Therapeutics, with offices in Shanghai China and Victoria Australia, is a clinical stage biotech company focused on the discovery, development and commercialization of innovative and transformative therapies for both psychiatric and neurological disorders. A pioneer in neuroplasticity hypothesis-based drug discovery and precision neurology, Zhongze Therapeutics integrates target- and phenotypic-based drug discovery with precision neurology approaches to discover and develop CNS therapies more efficiently and precisely. Our current leading assets are a phase II combo drug for substance use disorders, a phase I small molecule for schizophrenia and a phase I gut-acting and gut-restricted small peptide drug targeting the gut-brain axis through vagus nerve.
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