NovelMed Advances Its Ocular Program, Highlighting the Potential of a Single Therapy Across Multiple Retinal Diseases
--- A Versatile Complement Therapy Across Ocular, Hematologic, Renal, Dermatological, and Inflammatory Disorders. Key
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— A Versatile Complement Therapy Across Ocular, Hematologic, Renal, Dermatological, and Inflammatory Disorders.
Key Highlights
- Commercial Precedent for One Molecule, Two Diseases: Biogen’s $5.6 billion acquisition of Apellis added EMPAVELI for PNH and SYFOVRE for GA – two commercial products containing the same C3 inhibitor, pegcetacoplan. NM5072 presents a similarly compelling multi-indication opportunity across PNH and GA, supported by preclinical efficacy in models of both diseases. Its long half-life is designed to enable extended dosing intervals, improving patient convenience and strengthening the asset’s overall value proposition.
- Single Therapy for Wet and Dry Age-Related Macular Degeneration: In rhesus monkeys, a single intravitreal administration of NM5072 reduced choroidal neovascularization (CNV), hemorrhage, and fibrosis. These findings support its development as a single therapy for wet AMD, dry AMD, and ocular inflammation and its potential to become a best-in-class treatment for ocular disorders.
- Phase I Clinical Trial Completed: NM5072 completed a Phase I study in 48 healthy volunteers, generating clinical safety, pharmacokinetic (PK), pharmacodynamic (PD), and immunogenicity (ADA) data. No treatment-emergent immunogenicity was observed among NM5072-treated participants. The FDA has granted NM5072 Orphan Drug Designation for PNH, and additional clinical protocols are currently under FDA review.
- Direct Proof of Concept in Rhesus Monkeys: A single intravitreal dose of NM5072 reduced choroidal neovascularization (CNV) lesion area and improved measures of retinal fibrosis and hemorrhage. Ocular histopathology showed no evidence of drug-related ocular toxicity under the conditions of the study.
- Cross-Species Ocular Evidence: Two independent rabbit laser-induced CNV studies using a surrogate anti-properdin antibody demonstrated reductions in CNV area and volume, including an approximately 65% reduction in CNV volume at the higher dose in one study. Together with the direct NM5072 rhesus study, these findings provide cross-species support for ocular properdin inhibition.
- Modeled Ocular Durability: A rabbit intravitreal PK/PD study yielded an estimated ocular half-life of approximately 7 days. Translational modeling projects a human ocular half-life of approximately 21 days and suggests that NM5072 could remain above AP-inhibitory levels for more than 140 days. These projections will be evaluated in clinical trials.
CLEVELAND, Aug. 11, 2026 (GLOBE NEWSWIRE) — NovelMed Therapeutics, Inc., a clinical-stage biotechnology company developing selective blockers of the Complement Alternative Pathway (AP), today announced the advancement of NM5072, a Phase I-completed anti-properdin antibody, as an ocular development candidate with the potential to address multiple retinal diseases. The ocular development rationale is supported by compelling direct data in a rhesus CNV model, supportive rabbit studies, and ocular PK/PD and translational modeling. NM5072’s ocular program remains preclinical, and intravitreal NM5072 has not been evaluated in humans.
| “NM5072 brings together 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. “The breadth of these findings supports our vision of developing a single, durable therapy that could address multiple complement-driven retinal diseases, including GA.” |
NM5072: Advancing into Ocular Clinical Development
The Phase I study generated safety, pharmacokinetic, pharmacodynamic, and immunogenicity data and demonstrated selective inhibition of the Alternative Pathway while preserving the Classical Pathway. No treatment-emergent immunogenicity was observed among NM5072-treated participants.
The favorable safety profile and clinical characterization established in Phase I provide a strong foundation for NM5072’s ocular development program. Building on this clinical experience, NovelMed’s development plan includes ocular toxicology studies followed by clinical evaluation of NM5072 in geographic atrophy and other complement-associated ocular disorders over the coming months.
Compelling Rhesus CNV Data Across Multiple Retinal Injury Endpoints
In a laser-induced CNV study conducted by Charles River Laboratories in rhesus monkeys, NM5072 was administered as a single intravitreal dose. Treatment reduced CNV lesion area and improved measures of retinal fibrosis and hemorrhage, demonstrating activity across multiple retinal injury endpoints. Ocular histopathology showed no evidence of drug-related ocular toxicity under the conditions of the study.
These findings support further investigation into whether upstream proximal AP inhibition can influence both angiographic CNV and downstream fibrotic and wound-healing pathology.
Rabbit and Rhesus Models Provide Cross-Species Support
NovelMed’s ocular program is supported by compelling cross-species preclinical efficacy data from two prophylactic laser-induced CNV studies in Dutch Belted rabbits and a direct NM5072 study in rhesus monkeys. In the rabbit studies, intravitreal administration of a surrogate anti-properdin antibody reduced CNV area and volume compared with placebo, while a single intravitreal dose of NM5072 in rhesus monkeys reduced CNV pixel area and improved measures of retinal fibrosis and hemorrhage. Ocular histopathology in the rhesus study showed no evidence of NM5072-related ocular toxicity under the conditions of the study. Collectively, these findings provide compelling support for the continued development of NM5072’s ocular program and the therapeutic potential of Alternative Pathway inhibition across retinal disease models.
Modeled Ocular Durability Could Support Extended Dosing Intervals
NovelMed’s ocular PK/PD and translational modeling package includes the following projections:
• Rabbit ocular PK/PD: A single-dose intravitreal study yielded an estimated ocular half-life of approximately 7 days in rabbits.
• Projected human ocular half-life: Translational modeling projects a human ocular half-life of approximately 21 days.
• Projected therapeutic coverage: Modeling suggests that intravitreal NM5072 could remain above AP-inhibitory levels for 140 days (>4 months).
These projections have not been confirmed in humans and should not be interpreted as an established clinical dosing interval. Clinical studies will be required to characterize ocular pharmacokinetics, pharmacodynamics, safety, dose, efficacy, and duration of effect.
A Single-Therapy Strategy Across Multiple Retinal Diseases
Wet AMD is characterized by CNV, vascular leakage, and hemorrhage, while dry AMD involves progressive retinal tissue loss. The AP amplification loop can drive C3a- and C5a-mediated signaling, activate retinal pigment epithelial cells and immune cells, and promote downstream mediators, including VEGF, PDGF, and inflammatory cytokines. NovelMed’s antibodies are designed to intervene upstream of these mediators.
NovelMed’s development hypothesis is that selective AP inhibition may provide a broader disease-modifying approach than neutralizing an individual downstream mediator alone. The ocular strategy is focused on three related therapeutic and strategic priorities:
- Wet and Dry AMD: Complement biology and the potential for durable AP inhibition support evaluation of NM5072 in ocular disorders. Direct preclinical findings with NM5072 in a rhesus CNV model, including reductions in CNV, retinal fibrosis, and hemorrhage measures, provide a rationale for further evaluation in neovascular retinal disease.
- Broader ocular potential: Because complement-mediated inflammation and tissue injury contribute to multiple ocular disorders, NovelMed’s complement-targeted compounds may also have therapeutic potential in diabetic retinopathy, diabetic macular edema, retinal vein occlusion-associated macular edema, uveitis, and retinal vasculitis.
- Single-therapy objective: NovelMed plans to prioritize NM5072 as its lead ocular molecule and use translational and clinical data to determine whether a single AP-selective therapy could ultimately address both wet and dry AMD.
Figure Caption: A retina specialist administering an intravitreal antibody injection.
Development Strategy and Next Steps
Biogen’s 2026 acquisition of Apellis Pharmaceuticals for approximately $5.6 billion added Syfovre and Empaveli to its commercial portfolio and underscores strategic interest in complement-based ophthalmology and multi-indication platforms.
| “Biogen’s $5.6 billion acquisition of Apellis demonstrates the value of a single complement inhibitor serving both PNH and geographic atrophy,” said Joseph Jankowski, PhD, VP of Business Development at NovelMed. “NM5072 offers a similarly compelling multi-indication opportunity, supported by preclinical efficacy in models of both diseases and a long half-life that will enable extended dosing intervals.” |
NovelMed is seeking ophthalmology partners to support the development and commercialization of its ocular programs and remains interested in out-licensing, co-development, regional licensing, and other strategic partnership opportunities.
The Company’s broader alternative pathway portfolio includes multiple complement inhibitors, including the clinical-stage anti-Factor Bb antibody NM8074, which provides additional clinical validation of the Company’s alternative pathway platform.
Complement Dysregulation Across Multiple Retinal Diseases
Age-related macular degeneration (AMD), geographic atrophy (GA), diabetic retinopathy, macular edema, uveitis, retinal vasculitis, and other inflammatory retinal disorders involve varying degrees of complement activation, inflammation, vascular injury, and retinal tissue damage. In wet AMD, abnormal blood vessel growth, leakage, hemorrhage, and fibrosis contribute to vision loss, while dry AMD and GA are characterized by progressive degeneration of retinal cells and supporting tissue. Complement-mediated inflammation has also been implicated in diabetic retinal disease, retinal vascular disorders, uveitis, and retinal vasculitis.
By selectively inhibiting the Alternative Pathway upstream of multiple inflammatory and angiogenic mediators, NM5072 has the potential to provide a single therapeutic approach across multiple complement-associated ocular diseases, addressing both vascular and inflammatory mechanisms of retinal injury.
About NovelMed Therapeutics
NovelMed Therapeutics, Inc. is a privately held, clinical-stage biotechnology company developing antibodies that selectively target the Complement Alternative Pathway. NovelMed is advancing NM5072, a monoclonal antibody that has completed a Phase I clinical trial in paroxysmal nocturnal hemoglobinuria (PNH) and is now being developed for potential use across multiple retinal diseases. The company’s approach is designed to inhibit Alternative Pathway amplification while preserving Classical Pathway function. NovelMed is seeking out-licensing, co-development, regional commercialization, and other strategic collaborations that can accelerate the development of its programs. For more information, visit www.novelmed.com.
Media Contact
Ya Gao, MS | NovelMed Therapeutics, Inc.
media@novelmed.com | (216) 440-2696
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cf042b5d-b4ef-4840-acbb-70a17345f288
