Oncobiologics Advances ONS-5010 into wet AMD Clinical Trial

Oncobiologics (NASDAQ:ONS) today announced that it has begun dosing patients in its first clinical trial for ONS-5010, a proprietary ophthalmic bevacizumab product candidate, in patients with wet age related macular degeneration (wet AMD).

As quoted in the press release:

This first clinical study for ONS-5010, the Company’s lead product candidate, is being conducted outside of the United States and is designed to serve as the first of two adequate and well controlled studies for wet AMD.  The U.S. portion of the second study is scheduled to begin in early 2019 upon the submission of an investigational new drug (IND) application. The Company’s wet AMD clinical program was reviewed at a successful end of Phase 2 meeting held with the U.S. Food and Drug Administration (FDA) conducted earlier in 2018.  If the program is successful, it will support the Company’s plans to submit for regulatory approval in multiple markets in 2020.  The Company is developing ONS-5010 as an innovative therapy and not using the biosimilar drug development pathway.

“The commencement of the ONS-5010 clinical program targeting ophthalmic indications is a major achievement and I am extremely proud of the team for reaching this key milestone so quickly,” said Lawrence A. Kenyon, President, CEO and CFO. “We were able to enter the clinic in less than 12 months from the start of the project. ONS-5010 presents an exciting opportunity to meet the need for affordable critical therapeutic options for patients and we are planning to build on the progress achieved to date.”

Click here to read the full press release.