Molecular Partners AG Progresses Darpin Into First-In-Humans Clinical Studies
Zurich-Schlieren, Switzerland, April 30, 2010. Molecular Partners AG, the global leader in the development of DARPins as unique next generation protein therapeutics, announced today that it has enrolled the first cohorts of patients in two separate Phase I trials in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The trials are investigating the safety and tolerability of a single intravitreal injection of MP0112, a DARPin which inhibits all relevant forms of vascular endothelial growth factor A (VEGF-A) with high potency. The studies will also allow a preliminary assessment of efficacy and the duration of action of MP0112. MP0112 was engineered to have a long ocular half-life but fast systemic clearance. Thus, it has the potential to become the best-in-class inhibitor of neovascular diseases of the eye and to reduce the number of intravitreal injections needed as compared to current approved standard of care. Dr. Michael Stumpp, CSO commented: “The need for frequent intravitreal injections is the main limitation of current approved standard of care for wet AMD. We have optimized MP0112 to reduce ocular injections to ease the burden on both patients and physician practices. We are excited to see the first ever DARPin entering clinical development. This is an important step for the development of DARPin-based therapies, and through our internal pipeline we expect to see more DARPins entering the clinic for areas of unmet clinical need." Dr. Christian Zahnd, CEO added: “We are delighted to start clinical development of MP0112 just 2.5 years after the initiation of the program. This is a great showcase for the capabilities of the DARPin platform and further validates its potential to fill pipelines with differentiated products." About wet Age-Related Macular Degeneration and Diabetic Macular Edema Age-related macular degeneration (AMD) is the leading cause of blindness in patients over 50. The wet form of AMD is caused by growth of abnormal blood vessels or choroidal neovascularisation (CNV) under the central part of the retina. Leakage of fluid and blood from these vessels can cause scarring of tissue leading to severe vision loss. Inhibition of VEGF-A has been shown to be very effective in slowing down disease progression in the majority of patients and to restore vision in a proportion of patients. A key limitation of the currently licensed inhibitors is the need for frequent intraocular injections. Diabetic macular edema (DME) is the leading cause of vision impairment in diabetic patients, especially those younger than 60 years. Clinically significant DME occurs when neovascularisation occurs and fluid leaks into the central part of the retina. While standard of care, laser photocoagulation therapy, is able to slow disease progression, clinical studies with VEGF inhibitors have shown promising results with the potential to improve the vision of patients. About Molecular Partners (www.molecularpartners.com): Molecular Partners is a privately held biotech company focusing on the commercialization of a novel class of biological drugs known as DARPins. The company is committed to create medicines for diseases with unmet medical need and to dramatically improve existing therapies. DARPins combine the high specificity, selectivity and safety of monoclonal antibodies with many advantages of small molecules, including high stability and low-cost production. Molecular Partners has established a strong DARPin pipeline which is well differentiated from standard therapeutic approaches. Next to MP0112, Molecular Partners is focusing on DARPin drugs in inflammation, oncology and other disease areas. The internal pipeline is expanded by partnered programs with leading pharmaceutical companies. Molecular Partners has established collaborations with F. Hoffmann-la Roche, Centocor Research & Development Inc. and Bayer Schering Pharma. The company is backed by a strong syndicate of investors and holds a strong patent estate covering all DARPin applications.