Ixchelsis, a start-up company that has come out of Pfizer's former R&D site at Sandwich, UK, is progressing a treatment for premature ejaculation boosted by the backing of Eli Lilly.

Lilly, through its venture fund set up with TVM Capital Life Science, has invested in Ixchelsis, made up of former Pfizer scientists and headed by Gary Muirhead. The company is based on an oxytocin receptor antagonist called IX-01 originally discovered at Sandwich which the investors say "has the potential to be the best-in-class pharmacological approach for the treatment of PE".

Ixchelsis, which is based at the Sandwich site, now called Discovery Park, will collaborate with the autonomous early phase virtual drug discovery arm of Lilly, known as Chorus. Dr Muirhead told PharmaTimes that the TVM model will fund through to the agreed exit point, which is completion of proof-of-concept and this requires about $14 million.

There are currently no medicines approved by the US Food and Drug Admininstration to treat this condition. Italy's Menarini acquired the PE drug Priligy (dapoxetine) from Johnson & Johnson last year and the drug is now approved in over 50 countries, but not across the Atlantic.

Dr Muirhead notes that dapoxetine is a selective serotonin reuptake inhibitor, "with all of the adverse affects and safety issues that that class of drug carries". He adds that in addition, "its efficacy is limited by being given as a single administration which provides a sub-optimal effect on serotonin re-uptake".

The Ixchelsis chief told PharmaTimes it has been demonstrated that oxytocin is intrinsically linked to the ejaculatory process both in humans and animal models, so its inhibition "should provide a targeted and specific effect on ejaculation, without unwanted side effects". He added that data to date has demonstrated a very benign safety profile for IX-01.

Dr Muirhead was fulsome in his praise for Pfizer, saying that the drugs giant "has afforded continual business development, legal and venture capital advice and guidance to Ixchelsis over the past two years that we have been seeking funding". This support "has been pivotal to us getting to this point".
If the proof-of-concept results are positive, Lilly may have the opportunity to purchase the molecule. In terms of men's health, the company already markets the erectile dysfunction drug Cialis (tadalafil) and the testerone replacement therapy Axiron.