ONL101 is a first-in-class small molecule peptide currently under development to protect photoreceptors in retinal detachment, a condition for which the product has been granted orphan disease designation.
The SBIR grant will be used to support the remaining ONL101 preclinical development activities required to submit an investigational new drug (IND) application.
The company received this funding after the completion of a Phase I SBIR project which focused on showing the feasibility of its approach to block photoreceptor apoptosis in retinal detachment animal models.
The NEI-funded research showed that the company could deliver the target molecule intravitreally and achieve sufficient retinal concentrations to block apoptosis.
ONL Therapeutics chief executive officer John Freshley said: "This funding will allow for continued evaluation of ONL101’s ability to protect photoreceptors in cases of retinal detachment and, ultimately, preserve vision.
"Illustrating this mechanism of photoreceptor protection not only helps advance ONL101 as a treatment for retinal detachment but also provides rationale for the technology’s application to other important retinal diseases such as wet and dry age-related macular degeneration."
Apart from the SBIR grant, the company has also raised $1m through a convertible bridge loan from a syndicate led by the Capital Community Angels of Lansing, Michigan.
Currently, the company is preparing for IND-enabling preclinical activities for ONL101 with a plan of submitting an IND application in late 2015 to support the initiation of a Phase I clinical trial in retinal detachment.