Complement Inhibitors for Macular Degeneration

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R43EY019191-01A1
Agency Tracking Number: EY019191
Amount: $212,118.00
Phase: Phase I
Program: SBIR
Awards Year: 2009
Solicitation Year: 2009
Solicitation Topic Code: N/A
Solicitation Number: PHS2009-2
Small Business Information
NOVELMED THERAPEUTICS, INC., 2265 ENTERPRISE PKWY, TWINSBURG, OH, 44087
DUNS: 190155171
HUBZone Owned: Y
Woman Owned: Y
Socially and Economically Disadvantaged: N
Principal Investigator
 REKHA BANSAL
 (440) 477-9874
 REKHA@NOVELMED.COM
Business Contact
 REKHA BANSAL
Phone: (440) 477-9874
Email: rekha@novelmed.com
Research Institution
N/A
Abstract
DESCRIPTION (provided by applicant): Age-related macular degeneration (AMD) affects nearly 10 million people in the U.S (Research to Prevent Blindness Foundation). Recently approved anti-VEGF therapy is the only cure for wet AMD as of today. Recent studies have demonstrated the role of the alternative pathway (AP) in AMD. Gradual loss of vision eventually resulting in blindness is the key symptom of AMD in the adult population. Using the mouse AMD model, Bora et al demonstrated that complement factor B of the alternative pathway plays an important role in the disease. With the use of siRNA techniques, Dr. Bora demonstrated that silencing of the factor B gene prevents the induction and persistence of AMD. Encouraged by these results, we decided to evaluate the effect of our blocking anti-factor B monoclonal antibody (Bikaciomab) in inhibiting the development and progression of AMD. Bikaciomab binds factor B protein in human blood and blocks its function in AP mediated complement activation. Bikaciomab prevents alternative pathway mediated formation of C3a, C5a, and C5b-9, the key anaphylatoxins responsible for the inflammatory responses. We will test the effect of this blocking anti-factor B antibody in prophylaxis and established models of the disease to provide direct clinical relevance of the drug under testing. PUBLIC HEALTH RELEVANCE: Age-related macular degeneration (AMD) affects nearly 10 million people in the U.S (Research to Prevent Blindness Foundation). Recently approved anti-VEGF therapy is the only cure for wet AMD as of today. There is an unmet medical need in the area of macular degeneration. NovelMed's current approach focuses on neutralizing factor B function and providing disease benefit. Using the previously developed animal models of AMD, NovelMed intends to test its lead complement inhibitor for the treatment of AMD. Potent activity of Bikaciomab in vitro, ex vivo and in vivo makes the drug as a potential therapeutic for not only AMD but also for several diseases where alternative pathway plays an important role in disease pathology.

* Information listed above is at the time of submission. *

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