RegeneRx, a Rockville, MD-based biopharmaceutical company, has decided to put most of its resources for the near term into its dry eye treatment, RGN-259, the company announced in a news release. This shift in focus comes after some recent encouraging data on the drug, a preservative-free topical eye drop.
The company cites two recent studies in mice that resulted in "statistically significant improvement of corneal healing." Previous studies have shown that RGN-259 can repair the cornea even after it's been damaged by chemicals. So, based on the new data, RegeneRx has decided to go with this and plan a Phase II clinical trial to measure safety and efficacy in addition to ongoing physician-sponsored clinical trials in patients with dry eye.
"Because of the new positive data that complement our earlier human and animal ophthalmic data, the relatively short timeframe in which we believe we can generate human dry eye data in a Phase II trial, and the significantly reduced cost as compared with the Phase II AMI trial, we believe it is in the best interest of the company and our stockholders to place our highest priority on the clinical development of RGN-259," RegeneRx CEO J.J. Finkelstein said in a statement. "We are fortunate to have several drug candidates in development and the ability to quickly reprioritize our clinical focus."
The change in focus comes a month after RegeneRx was forced to halt a study on RGN-352, its injectable formulation of Thymosin beta 4 for acute myocardial infarction, because its contract manufacturer wasn't compliant with good manufacturing standards.
- read RegeneRx's release