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Investing.com — Ocugen, Inc (NASDAQ:OCGN) told investors Monday that it has submitted an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) to start a phase 1/2 trial of of its drug to treat inherited retinal degeneration.
Despite the announcement, Ocugen shares fell over 7%, to $9.52 on Monday.
“This important milestone brings us one step closer towards achieving our company’s vision of fostering a future where no one feels hopeless in the face of disease,” said Dr. Shankar Musunuri, the CEO and co-founder of Ocugen.
Ocugen’s modifier gene therapy platform intends to target nuclear hormone receptors (NHRs) that regulate multiple functions within the retina, giving it the possibility of addressing many different gene mutations – and, in turn, numerous retinal diseases.
The proposed phase 1/2 clinical study will assess the safety and proof-of-concept of the drug, called OCU400. The company has already completed manufacturing to support clinical studies.
Ocugen said it plans to follow the phase 1/2 trial with a phase 3 study once the data are further reviewed.
Last week the company submitted a request for emergency use authorization to the FDA for its Covid-19 vaccine for pediatric use.
