SciFluor Life Sciences announced that an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) is now in effect for SF0166 Topical Ophthalmic Solution, enabling the company to begin clinical trials in patients with wet age-related macular degeneration (AMD) and diabetic macular edema (DME).
Allied Minds’ subsidiary SciFluor is developing SF0166 has a topical treatment of retinal disease administered in the form of eye drops that could possibly substitute for the monthly intravitreal injections (into the back of the eye) required with current treatments for wet AMD and DME.
SF0166 is a potent and selective small molecule inhibitor of integrin αvβ3 with an optimum balance of physiochemical properties to allow it to dispense to the retina in high concentrations following topical administration.
If successful, this would be a major advance in the treatment of these retinal disease, which currently represents more than $8 billion in annual revenue.
SF0166 has been tested in an extensive set of preclinical assays and shown to be effective in a validated in vivo model of wet-AMD. The nonfluorinated compound on which it is based distributes effectively to the back of the eye after topical administration.
“The development of SF0166 provides validation of our fluorine-centered approach to bringing new transformational therapies to patients with serious illnesses,” Ben Askew, PhD, SciFluor vice president of research and the lead on the SF0166 therapeutic program, said in a press release.
“SF0166 demonstrates how appropriately placed fluorine modifications can improve the physical properties of a molecule, and address the challenge of getting enough drug to the back of the eye when administered using much more convenient eye drops,” he said.
The company will soon begin SF0166-C-001, a multi-center, randomized Phase 1/2 clinical trial to assess the preliminary efficacy and safety of SF0166 in patients with DME in the United States. A separate Phase 1/2 multi-center, randomized clinical trial of SF0166 is planned for patients with wet AMD.
Both studies are planned to have two dose groups of up to 20 patients for the purpose of collecting safety and tolerability data and to record alterations in retinal thickness.
“This achievement marks the beginning of a new era for SciFluor as a clinical development stage company,” said Dr. Omar Amirana, MD, SciFluor CEO and senior vice president at Allied Minds. “We are pleased to have advanced SF0166 rapidly through preclinical development culminating in a successful IND filing and look forward to generating the clinical data required to advance this potential new therapy.”
AMD is a medical condition which may result in blurred or no vision in the center of the visual field. Early in the disease there are often no symptoms. Over time, however, some people experience a gradual worsening of vision that may affect one or both eyes.
DME is an ocular manifestation of diabetes in which damage occurs to the retina due to diabetes. It can eventually lead to blindness.