IX-01, an investigational compound, was originally discovered at Pfizer’s Sandwich research and development site in the UK.
Under the randomized, double-blind, placebo controlled phase 2a study, Ixchelsis investigated the efficacy and safety of orally administered IX-01 in 88 patients with various lifelong PE in the US and Australia.
The drug was evaluated at doses of 400mg and 800mg, taken as needed before sexual intercourse.
The study showed that patients receiving IX-01 clinically and statistically significantly enhanced their intra vaginal ejaculatory latency times by over 3.5 fold compared to placebo.
Patients receiving IX-01 also reported statistically significantly greater improvements in their feelings of control and distress compared to placebo.
Ixchelsis said the proportion of patients rating their PE as slightly better, better or much better, as determined by the Clinical Global Impression of Change, was statistically greater for IX-01 compared to placebo.
The drug was also demonstrated to be well tolerated with a safety and adverse event profile same as for placebo.
Ixchelsis CEO Gary Muirhead said: "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. "