Trabodenoson (INO 8875) fails Phase III trial for primary open-angle glaucoma.- Inotek Pharmaceuticals Corporation.

Inotek Pharmaceuticals Corporation announced top-line results of MATrX-1, the first pivotal Phase III trial of trabodenoson for the treatment of primary open-angle glaucoma (POAG) or ocular hypertension (OHT). The trial did not achieve its primary endpoint of superiority in reduction of intraocular pressure (IOP) compared with placebo at all 12 time points. This was, in part, due to a placebo response that was 2-3 mmHg greater than that observed in Phase II.

Trabodenoson, the Company�s lead clinical candidate, is a first-in-class, highly selective adenosine mimetic targeting the A1 subreceptor. Trabodenoson lowers IOP by augmenting the eye�s natural function of the trabecular meshwork, the primary outflow pathway for aqueous humor and a site of pathology in glaucoma.

According to David P. Southwell, President and Chief Executive Officer of Inotek-. "This result was driven primarily by the unexpectedly stronger placebo response at the 8AM time point. However, MATrX-1 did achieve several clinically meaningful secondary endpoints- the 6% dose was significant versus placebo in the daily IOP change from diurnal baseline at all days tested. Additionally, an analysis of responders (subjects with IOP reduction of 5mmHg or greater from baseline) indicated a statistically higher proportion of responders in the 6% trabodenoson group than the placebo group at all visits. The safety, tolerability and low discontinuation rate in MATrX-1 continues to suggest that trabodenoson is an active molecule with a unique safety profile. Later this quarter, we expect to receive additional data beyond these top-line results. Once we have the additional data, we will determine next steps in the trabodenoson monotherapy program.�