Otitopic, Inc., founded in 2012, is a privately funded drug development company with a track record of success in biopharmaceutical product development. Otitopic has changed the route of administration of an approved reference listed drug product and intends to file a 505(b)(2) NDA for sale and marketing in the U.S. OTI-0726 is intended to reduce the risk of vascular mortality in patients with suspected acute myocardial infarction (MI).
Otitopic has completed their 28 day nonclinical studies and are preparing for a dose range study (first-in-man trial) expected to start in Q2 2019. This trial will immediately be followed by a pivotal PK/PD study to establish bioequivalence. The data required for approval is expected to be obtained by Q4 2019.