Zurich-Schlieren, Switzerland, April 28, 2011. Molecular Partners AG, a leader in the development of next generation therapeutics, announced today that it has completed two phase I/IIa clinical trials with MP0112, its lead molecule targeting VEGF-A. The DARPin molecule was shown to be safe and well tolerated in two separate Phase I/IIa trials in wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME).
Patients were recruited globally in the US and several European countries. The detailed results will be presented at the annual meeting of the Association for Research in Vision and Ophthalmology (ARVO) in Fort Lauderdale, FL (May 1st – 5th).
Two parallel trials, together including 50 wet AMD or DME patients, have shown that MP0112 is safe and well tolerated when given as a single intravitreal injection. Overall, the studies have indicated that MP0112 has high efficacy and long duration of action. The therapeutic effect was demonstrated to be dose dependent and to last for most of the patients of the higher dose cohorts for 16 weeks and beyond after a single injection of MP0112.
MP0112 was engineered to have a long ocular half-life and fast systemic clearance. Thus, it has the potential to become the best-in-class treatment of neovascular diseases of the eye, reducing the number of intravitreal injections needed as compared to current approved standard of care and possibly omitting the need for monthly loading doses.
Prof. Dr. Dr. Sebastian Wolf, Director of the Dep. of Ophthalmology, Inselspital, University Berne, Switzerland and Principal Investigator for the MP0112 wet AMD study commented: “MP0112 has been shown to be safe and well tolerated – and the potential for quarterly dosing is highly encouraging, especially without the need for monthly loading doses.”
Dr. Christian Zahnd, CEO of Molecular Partners added: “We are very pleased with the strong results and the fast progress of MP0112 bringing value to patients in less than four years from initiation of the program. The high safety and low-immunogenic potential seen in 50 patients validates the DARPin platform in general as a rich source of differentiated drugs.”
For further details please contact:
College Hill Life Sciences
Tel: +44 (0) 20 7866 7855
Dr. Christian Zahnd, CEO
Dr. Michael Stumpp, CSO
Tel: +41 (0) 44 755 77 00
MP0112 is a DARPin-based, small therapeutic protein, which inhibits all relevant forms of vascular endothelial growth factor A (VEGF-A) with high potency and selectivity. The molecule is under development for the treatment of wet age-related macular degeneration (AMD) and diabetic macular edema (DME). Its high efficacy has been demonstrated in various preclinical models. MP0112 has shown the potential to show significantly longer therapeutic effects in various animal models potentially leading to a drug with the need for less frequent dosing as compared to standard of care.
Wet 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.