Ixchelsis is pleased to announce that two abstracts relating to the results of the proof of concept trial (PEPIX) of IX-01 in men with lifelong premature ejaculation were accepted for presentation at the American Urology Association Annual Meeting.   The main efficacy and safety results of the trial were presented by the Principal Investigator, Dr Chris McMahon at a podium session on Tuesday May 16th.  The abstract reference is PD69-01 and a link to the abstract is provided here http://www.jurology.com/article/S0022-5347(17)34608-6/abstract .

The results from the combination of objective and subjective efficacy instruments used in this study  were further analysed and found to be highly correlated.  A summary of these results were presented by Dr Stan Althof at a moderated poster session on Monday May 15th.  We are very pleased to  announce that this was awarded best poster in the Sexual Dysfunction Evaluation II Poster Session. The abstract reference is MP84-07 and a link is provided here http://www.jurology.com/article/S0022-5347(17)34114-9/fulltext .

Dr Stan Althof also presented a brief overview of the development of IX-01 for PE as the Meeting of the Sexual Medicine Society of North America on Friday May 12th.

Ixchelsis CEO, Gary Muirhead attended BioTrinity in London, May 08-10 2017. Please contact us through the website for further information.

Following the positive proof-of-concept data released in 2016, Ixchelsis is pleased to announce the start of the Phase II B dose range-finding study for IX-01 in February 2017. The study is a US based, double-blind, placebo-controlled multicentre trial assessing the efficacy of IX-01 across several doses in patients with severe lifelong PE. The study is due to complete recruitment later this year. For further information please see: https://www.clinicaltrials.gov/ct2/results?term=NCT03055806&Search=Search .

London, December 5, 2016 – Pfizer Venture Investments (PVI) and TVM Life Science Ventures VII today announced that they are making an additional $12M investment in Ixchelsis Ltd, a start-up company based at Discovery Park, Sandwich, Kent, UK. This funding will enable Ixchelsis to fully fund their planned Phase 2b study of IX-01 in patients with severe lifelong premature ejaculation.

Ixchelsis Ltd had previously reported, in January 2016, that it had achieved positive clinical proof of concept (POC) for IX-01, its oral oxytocin receptor antagonist, in patients with lifelong premature ejaculation. IX-01 demonstrated significant efficacy together with a very benign safety and toleration profile in patients suffering from the most severe lifelong form of PE.

“Ixchelsis is delighted to have secured this additional funding that will enable us to continue the ongoing development of IX-01through to the completion of our planned Ph2b study, which will start dosing early next year. This funding will also support our CMC and toxicology activities enabling rapid progression to Phase 3. We really appreciate and value the continued excellent collaboration and support from the TVM Capital Life Science team and Pfizer in helping us move IX-01 closer to treating patients with this common and distressing condition.” said Gary Muirhead, CEO of Ixchelsis Ltd.

“We are very excited by the progress Ixchelsis has made with the development of IX-01 and we believe that it underpins the viability and success of our investment model. The Ixchelsis team progressed IX-01 to successful completion of proof of concept, 11 months ahead of schedule and considerably under the original budget. This additional investment further exemplifies our confidence in the asset, the market size of the PE indication and the excellence of this management team.” said Luc Marengere, Ph.D., Managing Partner of TVM Capital Life Science based in Montreal and board member of Ixchelsis Ltd. He added, “Ixchelsis remains at the heart of TVM Life Science Ventures VII strategy.  IX-01 addresses a significant unmet medical need for a sizeable proportion of the global adult male population and which can have a major impact on the quality of life for men and their partners.”

Ixchelsis Ltd was the second investment for TVM Life Science Ventures VII, a venture capital fund domiciled in Montreal QC, which follows a new investment approach to developing pharmaceutical assets, in a capital efficient fashion in single asset companies.

Barbara Dalton, Ph.D., Vice President, PVI and board member of Ixchelsis Ltd said, “Pfizer Inc. is committed to scientific innovation in the U.K., and across the globe, collaborating in new and dynamic ways with other innovators across the healthcare landscape. Pfizer Venture Investments is pleased to support the external development of 1X-01, originally discovered at the Pfizer Sandwich site in the U.K.  It’s great to see that our efforts have helped IX-01 to advance through exploratory development and into Phase 2b dosing ranging.  Our additional investment demonstrates our confidence in the Ixchelsis team and in the ongoing development of 1X-01.”

Sandwich, UK – Jan 2016

Ixchelsis Ltd, a UK based biotech company, announced today 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 randomised, 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.”

For more information about Ixchelsis Ltd, please contact:

Gary Muirhead, Chief Executive Officer:

T: +44 (0)1304 892397

E: info@ixchelsis.com

About Ixchelsis Ltd

Ixchelsis Limited is an independent biotechnology company based in Discovery Park, Sandwich, UK. Ixchelsis is developing IX-01, an investigational compound, originally discovered at Pfizer’s, Sandwich, UK, R&D site. IX-01 is an oxytocin receptor antagonist with the potential to treat the male sexual health indication, premature ejaculation (PE).

Ixchelsis is funded by TVM Life Sciences Ventures VII and is led by CEO, Gary Muirhead together with an excellent management team with extensive experience in pharmaceutical R&D, particularly in the male sexual health therapeutic area.

About Premature ejaculation

Premature ejaculation is a sexual dysfunction affecting many adult males. Men with PE have great difficulty in delaying or controlling ejaculation during sexual intercourse. As a result, sexual intercourse only lasts a short time and finishes much earlier than the couple wish. This is distressing for both the man and his partner and can lead to low self-esteem, difficulty in relationships and avoidance of intimacy.   For many men PE is a condition they have throughout their adult life, but for some men the condition can be triggered by other factors (e.g. some men with erectile dysfunction also develop PE).

 

 

Gary Muirhead, Ixchelsis CEO presented at BIO-Europe in Vienna last November 3rd-6th 2013

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Ixchelsis team, Ian Osterloh, Liz Littlewood, Gary Muirhead and Karl Gibson kick-off the IX-01 program with Chorus in Indianapolis

Montreal, August 6, 2013 – Ixchelsis Ltd and TVM Life Science Ventures VII today announced the fund’s second investment – Ixchelsis Ltd, a start-up company based at Discovery Park, Sandwich, Kent, UK. Ixchelsis plans to develop to proof-of-concept, IX-01, an investigational compound, originally discovered at Pfizer’s, Sandwich, UK, R&D site, with the potential to treat the male sexual health indication, premature ejaculation…  Read More >>

Ixchelsis retains Bonaccord as corporate legal counsel (www.bonaccord.eu), November 2011.