Key Highlights
- Multi-indication precedent: Biogen’s approximately $5.6 billion acquisition of Apellis added EMPAVELI for PNH and SYFOVRE for GA, both of which contain pegcetacoplan.
- Primate proof of concept: A single intravitreal dose of NM5072 reduced CNV, hemorrhage, and retinal fibrosis in a rhesus monkey model.
- Phase I clinical experience: NM5072 completed a Phase I study in 48 healthy volunteers and received FDA Orphan Drug Designation for PNH.
- Potential extended durability: Rabbit PK/PD data estimated an ocular half-life of seven days. Translational modeling projects approximately 21 days in humans, with therapeutic levels maintained for up to 140 days.
CLEVELAND, Aug. 11, 2026 (GLOBE NEWSWIRE) — NovelMed Therapeutics, Inc., a clinical-stage biotechnology company, announced that it is advancing NM5072 as an ocular development candidate for multiple complement-associated retinal diseases. The program is supported by efficacy findings in rhesus monkey and rabbit models, as well as Phase I clinical safety data.
| “NM5072 combines Phase I 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.” | |
Ocular Efficacy and Durability
NovelMed plans to conduct ocular toxicology studies before evaluating NM5072 clinically in geographic atrophy and other complement-associated ocular disorders.
In a laser-induced CNV study in rhesus monkeys, a single intravitreal dose reduced CNV lesion area and improved measures of retinal fibrosis and hemorrhage, with no evidence of drug-related ocular toxicity. In rabbit studies, treatment with NM5072 also reduced CNV area and volume, providing cross-species support for the program.
A single-dose intravitreal study yielded an estimated ocular half-life of approximately 7 days in rabbits. Translational modeling projects a human ocular half-life of approximately 21 days and suggests that the drug could remain above AP-inhibitory levels for 140 days (>4 months), potentially supporting dosing intervals of more than four months.
Potential Across Multiple Retinal Diseases
Wet AMD involves abnormal blood-vessel growth, leakage, hemorrhage, and fibrosis, while dry AMD and geographic atrophy involve progressive retinal degeneration. Complement activation can amplify inflammation and promote downstream mediators, including VEGF, PDGF, and inflammatory cytokines.
By acting upstream of these mediators, NM5072 may offer a broader disease-modifying approach than therapies that target a single downstream pathway. Potential applications include:
- Wet and dry AMD
- Diabetic retinopathy and diabetic macular edema
- Retinal vein occlusion-associated macular edema
- Uveitis and retinal vasculitis
NovelMed’s objective is to determine whether NM5072 could ultimately address multiple complement-associated ocular diseases.
Figure caption: A retina specialist administering an intravitreal antibody injection.
Development and Partnership Strategy
Biogen’s acquisition of Apellis highlights interest in complement-based ophthalmology and multi-indication platforms. NM5072 represents a broad multi-indication opportunity, supported by preclinical efficacy in both PNH and retinal models and the potential for extended dosing intervals.
| “NM5072 offers a compelling multi-indication opportunity supported by preclinical efficacy and a long half-life,” said Joseph Jankowski, PhD, Vice President of Business Development at NovelMed. | |
NovelMed is seeking ophthalmology partnerships for out-licensing, co-development, regional licensing, commercialization, and other strategic collaborations. Its broader portfolio includes NM8074, a clinical-stage anti-Factor Bb antibody providing additional clinical validation of its Alternative Pathway platform.
About NovelMed
NovelMed Therapeutics, Inc. is a privately held, clinical-stage biotechnology company developing antibodies that selectively target the Complement Alternative Pathway while preserving Classical Pathway function. The company is developing NM5072 as a selective Complement Alternative Pathway therapy with potential applications across ocular, hematologic, renal, dermatologic, and inflammatory disorders.
NovelMed is seeking out-licensing, co-development, regional commercialization, and other strategic collaborations to accelerate the development of its programs. For more information, visit www.novelmed.com.
Media Contact
Ya Gao, MS | NovelMed Therapeutics, Inc.
[email protected] | (216) 440-2696
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/ccefb52b-955f-4efe-8028-55ee212c026d
