ONL Therapeutics has been awarded a $1.37 million Small Business Innovation Research (SBIR) phase II contract from NIH’s National Eye Institute (NEI) to advance development of ONL101, a first-in-class small molecule peptide. ONL101 was initially being developed for the protection of photoreceptors in retinal detachment, a condition for which the product was granted orphan disease designation last year. The company said the SBIR grant will be used to support the remaining preclinical development activities required for submission of an IND application.
This funding comes after the successful completion of a phase I SBIR project, which focused on demonstrating the feasibility of the company’s approach to blocking photoreceptor apoptosis in retinal detachment animal models. The research showed that ONL could deliver the target molecule intravitreally and achieve sufficient retinal concentrations to block apoptosis.
According to ONL, the therapeutic candidate works by protecting photoreceptors against the programmed cell death that occurs during the course of a broad range of retinal diseases and conditions. Preclinical data demonstrates ONL101’s ability to protect photoreceptors against the apoptosis process triggered by retinal detachment. In in vivo retinal detachment models, up to 80% of the photoreceptor cells that would normally die without treatment were kept alive following administration of ONL101, the company reported.
“Receipt of this second SBIR grant from the National Eye Institute provides further validation for our foundational photoreceptor protection technology, as well as our ONL101 product,” said John Freshley, CEO. “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.”