Key Takeaways
- NovelMed is advancing the Alternative Pathway inhibitor NM5072 toward clinical development for geographic atrophy and other complement-associated retinal diseases
- A single intravitreal dose reduced CNV lesion area and measures of fibrosis and hemorrhage in a rhesus monkey model, while rabbit studies provided additional efficacy data.
NovelMed Therapeutics is advancing NM5072 as an ocular development candidate for geographic atrophy (GA) and other complement-associated retinal diseases, supported by preclinical efficacy findings and phase 1 clinical safety data.
NM5072 is designed to selectively inhibit the complement "Alternative Pathway" (AP), an inflammatory pathway implicated in several retinal diseases. NovelMed said it plans to conduct ocular toxicology studies before moving the candidate into clinical evaluation for GA and potentially other ophthalmic indications.
“NM5072 combines phase 1 clinical experience, selective Alternative Pathway inhibition, and compelling primate data showing activity across CNV, fibrosis, and hemorrhage,” said Rekha Bansal, PhD, chief executive officer of NovelMed Therapeutics. “These findings support our vision of developing a durable therapy for multiple complement-driven retinal diseases, including geographic atrophy.”
In a laser-induced choroidal neovascularization (CNV) study in rhesus monkeys, a single intravitreal dose of NM5072 reduced CNV lesion area and improved measures of retinal fibrosis and hemorrhage, according to NovelMed. The company reported no evidence of drug-related ocular toxicity in the study.
NM5072 also reduced CNV area and volume in rabbit studies, providing efficacy findings across 2 preclinical species.
Pharmacokinetic data may also support extended dosing intervals. In a single-dose intravitreal rabbit study, NM5072 had an estimated ocular half-life of approximately 7 days. NovelMed said translational modeling projects an ocular half-life of approximately 21 days in humans.
Based on that modeling, the company estimates NM5072 could remain above concentrations required for AP inhibition for approximately 140 days, or more than 4 months. If confirmed clinically, the pharmacokinetic profile could potentially support dosing intervals exceeding 4 months.
NovelMed is positioning NM5072 as a potential treatment across a range of retinal disorders in which complement activation may contribute to disease progression.
NovelMed is also pursuing ophthalmology partnerships for NM5072, including potential out-licensing, co-development, regional licensing, commercialization, and other strategic collaborations. The company's broader complement portfolio includes NM8074, a clinical-stage antibody targeting complement Factor Bb. NovelMed views that program as additional clinical validation of its Alternative Pathway platform.
