SBIR Award, $1M Investment Get ONL Therapeutics to Clinical Trials

ONL Therapeutics, a University of Michigan spin-out biopharmaceutical startup working on sight-preserving therapies for retinal diseases, announced today that it has won a $1.3 million Small Business Innovation Research (SBIR) Phase II award from the National Eye Institute.

The SBIR funding will go toward the development of ONL101, a small-molecule peptide initially created for the protection of photoreceptors in retinal detachment—a condition that has earned an orphan disease designation from the FDA—and getting the drug to human clinical trials.

Photoreceptors, which are cells in the eye that process light, don’t replicate in the body after a person is born. The ONL101 therapeutic works by protecting photoreceptors against the programmed cell death (apoptosis) that happens during the course of certain retinal diseases and conditions, says John Freshley, ONL’s CEO. Apoptosis is the leading cause of blindness, he adds.

“What’s unusual and what’s got me excited is that nobody else is working specifically on this problem—the underlying cause of photoreceptor death,” Freshley says, adding that ONL’s drug can function as a complement to retinal disease treatments being developed by other companies. “We can keep photoreceptors alive until other therapies can be tried. People in the (retinal disease) community are very excited about what we’re doing. The potential is tremendous.”

ONL Therapeutics launched in 2011 and the technology behind ONL101 was developed at U-M by David Zacks. Based in Ann Arbor, the company has two full-time employees and a host of consultants. Freshley estimates the market for a therapeutic capable of safely and effectively preventing photoreceptor death in age-related macular degeneration, diabetic retinopathy, and other retinal diseases is worth as much as $15 billion globally.

ONL snagged the Phase II SBIR award after successfully completing a Phase I project that focused on demonstrating the feasibility of the company’s approach to blocking photoreceptor apoptosis in animals with retinal detachment. Freshley says the company hopes to file an investigational drug application, the first step toward human clinical trials, with the FDA by late next year.

ONL Therapeutics also announced today that it has raised $1 million from a syndicate led by the Capital Community Angels of Lansing, MI.  Additional investors include the Biosciences Research and Commercialization Center at Western Michigan University (with funds from the Michigan Economic Development Corporation), ONL management, and other undisclosed investors. ONL plans to raise a Series A round to get through clinical trials.

“The combination of the SBIR grant and investment provides sufficient funds to get us to our Series A,” Freshley says. “We’re also talking with potential pharmaceutical partners. We’ll begin raising our Series A next year, which will allow us to go full speed into clinical trials.”

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