Date: 2013-01-17
Type of information: Publication of results in a medical journal
phase: 1-2a
Announcement: publication of results in The American Journal of Ophthalmology (AJO).
Company: Molecular Partners (Switzerland)
Product: anti VEGF DARPin MP0112
Action
mechanism: protein. 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).
Disease: wet age-related macular degeneration (wet AMD)
diabetic macular edema (DME)
Therapeutic area: Ophtalmological diseases
Country: USA, Europe
Trial details:
Latest
news: * On January 17, 2013, Molecular Partners announced that the results of a Phase I/II study evaluating the safety and preliminary activity of MP0112, in patients with Diabetic Macular Edema (DME) have been published on-line in The American Journal of Ophthalmology (AJO). MP0112 was shown to be safe, and to suppress VEGF-A concentrations in aqueous humor after a single intraocular injection, with a pharmacokinetic half-life of about 2 weeks. These effects were accompanied by a stabilization or improvement in visual acuity and reduction of retinal edema (measured with optical coherence tomography) for up to 12 to 16 weeks. 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.
In 2011, Molecular Partners licensed the molecule under an exclusive agreement to Allergan for clinical development in retinal diseases. Allergan is currently evaluating the molecule in a phase 2b trial in 200 patients with exudative AMD based on an optimized manufacturing process and formulation (AGN-150998). Data from this study are expected in 2013.
* On April 28, 2011, Molecular Partners announced 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). These 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.
