SilkTech Biopharmaceuticals’ IND Submission Cleared by FDA for Dry Eye Drop
SilkTech Biopharmaceuticals announced the company has received clearance of its investigational new drug (IND) submission with the FDA for its SDP-4 eye drop product. In addition, the company has initiated a phase 2 clinical trial for its first-in-class drug to assess the safety and efficacy of the use of the product in treating the signs and symptoms of DED.
“We are proud to have initiated what we believe to be the first human clinical trial to assess a silk-derived protein biologic drug for treating an ophthalmic condition. And we are especially excited to have the opportunity to assess the impact of this compound in patients who suffer from the debilitating effects of DED,” CEO and cofounder Brian D. Lawrence, PhD, said in a company news release.
With the IND submission clearance, SilkTech has reached a new milestone that brings the company an additional $6.2 million in available venture financing from Skyview Ventures (Los Angeles) to support the phase 2 clinical trial and ongoing development work. The total available Series A funding is $11.2 million.
“As a patient who himself suffers from dry eye, I could not be more enthusiastic about seeing this novel therapeutic entering the clinic,” Alex Soltani, CEO of Skyview and a member of the SilkTech board of directors, said in a company news release. “As an investment partner, we believe this technology could represent a paradigm shift in the treatment of this disease.”
About the SDP-4 Eye Drop
SDP-4 offers a novel biotherapeutic approach that uses a naturally derived silk protein to treat DED through a dual-mechanism of action. It has been designed to inhibit the inflammatory mediators that may promote the symptoms of DED. Additionally, since SDP-4 is a protein in nature, the design of the eye drop formulation is intended to utilize the inherent spreading and wetting properties that a soluble protein may impart on the eye’s surface to stabilize the tear film and potentially improve physical comfort. The eye drop is supplied in single-unit dose containers as a preservative free, water-based formulation that is stored at room temperature.
“The SDP-4 eye drop is designed to utilize an innovative biologic approach to dealing with the inflammation and tear film instability that occurs in patients suffering from dry eye disease,” Edward Holland, MD, of the Cincinnati Eye Institute and a globally recognized expert in DED, said in the news release.