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.”