Head of Research Ovoca Bio Dublin 2, Dublin, Ireland
The preclinical developability of Orenetide a small peptide (5 amino acids) against a previously unused target in a CNS-based disorder will be presented in this talk. The therapeutic is intended for premenopausal women with hypoactive sexual desire disorder (HSDD). The mechanism of action and studies related to identifying the target in the brain needed further elucidation which will be described in this talk. The early process-related challenges pertaining to the synthesis of a small peptide and establishing control specifications for a CMC package will be covered. The nonclinical safety studies and findings from early phase clinical studies will be presented to provide the challenges faced in understanding the impact on exposure, safety and efficacy for CNS-based novel target.
Learning Objectives:
The audience will be able to understand the novel mechanisms and unused targets related to CNS based targets
The participants will get an understanding of the steps needed during preclinical stage to develop a package for IND enabling studies and FIH trials
The attendees will learn about the unique challenges related to small peptide- based therapies and their delivery through intranasal route of delivery
