Allied Minds investment SciFluor gets nod from FDA

Life science and technology investor Allied Minds announced on Monday that one of its key subsidiaries, SciFluor Life Sciences, has achieved the necessary scientific and regulatory milestones to enter clinical trials.

The FTSE 250 company said SciFluor’s Investigational New Drug application to the Food and Drug Administration by SciFluor is now in effect for SF0166 Topical Ophthalmic Solution.

This enables the company to initiate clinical testing of SF0166 in both wet age-related macular degeneration and diabetic macular edema patients, two retinal diseases that are among the leading causes of blindness globally.

AMD and DME patients are typically treated by regular injections to the back of the eye, Allied Minds said, but SF0166 will be administered in the form of eye drops, and is intended to replace these monthly injections.

If successful, the board said it would represent a major advance in the treatment of these diseases, which today represents in excess of $8bn in annual revenue.

“Today's announcement represents a very significant commercialization milestone for SciFluor,” said Allied Minds chief executive Chris Silva.

“The team has demonstrated that their expertise in the application of fluorine creates potential novel treatments for major indications.

“With the IND application to the FDA in effect for SF0166 we will commence two Phase I/II trials in AMD and DME patient groups of up to 20 individuals each.”

Silva said AMD and DME are unfortunately prevalent conditions, with AMD the leading cause of blindness for people over 55 in the developed world.

“As sufferers are currently treated by invasive injections, we are extremely pleased to be advancing this topical eye drop alternative into trials,” Silva added.

SciFluor chief executive officer and senior vice president at Allied Minds, Omar Amirana, said the achievement marks the beginning of a new era for SciFluor as a clinical development stage company.

“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.”