TetraLogic Pharmaceuticals Corporation announced the results of the interim analyses of two clinical studies. In a placebo controlled Phase 2 study of birinapant co-administered with azacitidine in first line higher risk patients suffering from myelodysplastic syndromes (MDS), birinapant did not demonstrate any clinical benefit over placebo on the primary endpoint of response rate after four months of therapy and met the bounds for futility. This interim analysis included the first 62 patients randomized in the trial.

This study will now be terminated. TetraLogic has undertaken an interim analysis of a randomized Phase 2 clinical study of SHAPE, the company's proprietary topical HDAC inhibitor. The clinical trial was designed to investigate the safety and efficacy of three different dosing regimens of SHAPE in patients suffering from earlier stage cutaneous T-cell lymphoma (CTCL).

All patients in the study had received prior therapy either in the form of topical steroids, UV light therapy, topical nitrogen mustard, or some other agent. Twenty-eight of 34 patients were evaluable for response at the 6 month time point. After six months of treatment, 8 of 34 patients exhibited a response to treatment as assessed by CAILS, the primary endpoint, and a further 18 had stable disease.

Using the mSWAT, a secondary endpoint in the study, 11 of 34 patients responded and a further 14 patients had stable disease at the 6 month endpoint. SHAPE also showed improvement in pruritus (itch), a significant symptom associated with CTCL. A 38% of patients demonstrated a clinically meaningful decrease in pruritus during the study as measured by a Visual Analog Scale.

The drug was well tolerated by patients in the study. The 60 patient study is now fully enrolled, and the company expects that final results will be available in mid-2016.