SciFluor Life Sciences, a subsidiary of Allied Minds, announced positive topline results of a phase 1/2 study of SF0166, the company’s lead drug in development for the topical (eye drop) treatment of patients with diabetic macular edema (DME), according to a company news release.
The phase 1/2 study assessed the safety and preliminary efficacy of SF0166 in 40 evaluable patients with DME who were randomized to one of two dose strengths (2.5% and 5.0% solutions) self-administered by patients as an eye drop twice-a-day for 28 days, with a 28 day follow-up period. Results from a trial of SF0166 in patients with age-related macular degeneration (AMD) remain pending.
The primary outcome measure of safety was achieved with no drug-related serious adverse events observed in the study throughout the 28-day course of treatment as well as during the 28-day follow-up period. Ocular adverse events were recorded in the treated eyes of 6 patients. All events were mild in severity, with one considered possibly drug-related.
SF0166 demonstrated biological activity in both patient groups (2.5% and 5% solutions), with 53% of the evaluable patients demonstrating a reduction in retinal thickness (RT), and improvements in visual acuity were also recorded. Durability of RT response to the 28-day course of therapy was observed during the month after discontinuing treatment.
There were no significant decreases in visual acuity in study eyes during treatment or follow-up and no patient required rescue treatment with an anti-VEGF injection during the treatment phase. Regular anti-VEGF injections to the eye represent current standard of care for DME (and AMD).
Based on these outcomes, SciFluor has decided to proceed to phase 2 trials for SF0166.
“The safety and biological activity, clearly demonstrated in this first-in-patient study, supports continued clinical development of SF0166,” David Boyer, MD, Retina-Vitreous Associates Medical Group of Los Angeles, said in the news release. “DME is a devastating condition that often results in vision loss. A safe and effective eye drop treatment for patients living with DME would be a major advance in the fight against this debilitating disease. A potential eye-drop treatment for DME may not only increase compliance, but also allow the opportunity to prevent vision loss by treating earlier in the disease pathway.”
“We believe SF0166 represents an important breakthrough in the treatment of retinal disease given its unique mode of action and its administration as an eye drop” Omar Amirana, MD, SciFluor’s Chief Executive Officer and Senior Vice President at Allied Minds, said in the news release. “We look forward to further advancing SF0166. We would like to thank the patients who participated in this study and the investigators and study staff who share our commitment to advancing the treatment of DME.”
Jill Smith, CEO of Allied Minds, commented “These results provide strong validation of the preclinical work undertaken at SciFluor with regard to SF0166, and a clear case for proceeding to phase 2 trials, for which SciFluor is now preparing. Results for wet-AMD phase 1/2 trials are due later this year. SF0166 is targeting a very large and growing market, with existing injectable drugs for DME and wet-AMD generating combined annual revenues exceeding $8 billion.”