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, announced that it 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 non-exclusive rights to the data and a time-limited option to acquire worldwide exclusive ownership of the MAKO clinical trial database.
The MAKO study was a 237 patient, multicenter, randomized, double-masked, placebo-controlled clinical trial to evaluate the efficacy and safety of squalamine and Lucentis combination therapy versus Lucentis monotherapy for the treatment of wet AMD. Ohr reported in January 2018 that the study did not meet its primary endpoint.
Vitrisa is acquiring the clinical database in order 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 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 sub-analyses of the MAKO study with the retina community at future scientific meetings.”
Through an upfront payment, Vitrisa will gain initial non-exclusive access to summary data for the Lucentis monotherapy arm in the MAKO study and the option to acquire worldwide exclusive ownership of the entire clinical database for a period of 90 days following initial access. Specific financial details of the deal were not disclosed.