Ixchelsis Ltd has announced that it has achieved positive clinical proof of concept (POC) for IX-01, its oral oxytocin receptor antagonist being developed for the treatment of premature ejaculation (PE).
The Phase 2a study (PEPIX) was a randomized, double–blind, placebo controlled study, designed to investigate the efficacy and safety of orally administered IX-01 at doses of 400mg and 800mg, taken as required prior to sexual intercourse, in 88 patients with severe lifelong PE in the U.S and Australia.
The study demonstrated that patients receiving IX-01 clinically and statistically significantly (P<0.01) improved their intra vaginal ejaculatory latency times (IELT) by more than 3.5 fold compared to those patients receiving placebo.
Patients receiving IX-01 also reported statistically significantly greater improvements in their feelings of control (P <0.05) and distress (P <0.05) compared to patients receiving placebo. In addition, the proportion of patients rating their PE as slightly better, better or much better, as determined by the Clinical Global Impression of Change (CGIC), was statistically significantly greater for IX-01 compared to placebo (P <0.01).
The drug was also shown to be extremely well tolerated with a safety and adverse event profile similar to that seen for placebo.
Gary Muirhead, Chief Executive Officer of Ixchelsis, commented: “We are delighted to have achieved clinical proof of concept for IX-01. We are particularly pleased that we have demonstrated significant efficacy together with a very benign safety and toleration profile in patients suffering from the most severe lifelong PE. We are now progressing into a Phase 2b dose ranging study to fully evaluate the dose response relationship. We believe that, based on these data and the current lack of safe and effective treatments, IX-01 has the potential to be a blockbuster treatment for PE.”
Dr Chris McMahon, Director of the Australian Centre for Sexual Health in Sydney, Australia and the Principal Investigator for the study, said “These results are very exciting, we had hypothesised that a centrally acting oxytocin receptor antagonist should be effective in treating PE and these clinical data confirm that hypothesis. The treatment options for PE are extremely limited and IX-01 offers the potential to be first-line pharmacological treatment for men with this common and distressing condition.”
The proof of concept study was conducted by New England Research Institutes, an independent contract research organization in Watertown, Massachusetts. Dr. Raymond Rosen, Chief Scientist of New England Research Institutes and international thought leader in sexual medicine, commented: “Along with its unique mechanism of action, IX-01 has an excellent profile of efficacy and tolerability. This may be an ideal treatment for many millions of men worldwide who suffer from premature ejaculation.”