Vitrisa Therapeutics, a company focused on developing a suite of platform technologies optimized for ocular therapeutics and an associated pipeline of therapeutics in sight-threatening ocular diseases, has entered into an option agreement with Ohr Pharmaceutical for certain rights to the data from the MAKO study in wet AMD. Under the terms of the newly announced deal, Vitrisa will initially receive nonexclusive rights to the data and a time-limited option to acquire worldwide exclusive ownership of the MAKO clinical trial database.
The phase 3 MAKO study was a 237-patient, multicenter, randomized, double-masked, placebo-controlled clinical trial to evaluate the efficacy and safety of topical squalamine and ranibizumab (Lucentis; Genentech) combination therapy vs ranibizumab monotherapy for the treatment of wet AMD. Ohr Pharmaceutical reported in January 2018 that the study did not meet its primary endpoint. Vitrisa is acquiring the clinical database to use the clinical data set to run virtual clinical trials and evaluate innovative clinical strategies in wet AMD.
“We are excited to gain access to the rigorously collected data from the MAKO study in order to better inform our clinical strategy for our programs in wet AMD,” said Carl Erickson, CEO of Vitrisa. “Despite not meeting the primary endpoint, the MAKO study was a well designed and well run study in wet AMD that included a gold standard anti-VEGF monotherapy arm. With access to the clinical database, we will be able to de-risk our programs through virtual clinical trials using the Lucentis monotherapy arm and simulated treatment effects based on our programs in wet AMD. In addition, we are pleased to be able to have the option to share the results of our subanalyses of the MAKO study with the retina community at future scientific meetings.”