ARCHAMPS TECHNOPOLE and TOULOUSE, France, March 15, 2017 /PRNewswire/ --
Following successful fundraising with French and foreign investors, the start-up specializing in developing treatments for Urogenital Disorders launches its first phase II clinical study on Litoxetine.
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IXALTIS, SA with capital of €538 784, is specialized in Genitourinary and kidney disease, with their primary activity in experimental research and development of innovative compounds. IXALTIS has acquired rights to three molecules, including Litoxetine (IXA-001) under exclusive license from Sanofi. The first pre-clinical trials, conducted by private and academic institutes, have yielded positive results in treating urinary incontinence. This condition affects about 400 million worldwide and up to 50% of women over 50, for an estimated growth of 21% by 2018.
Launch of Phase II study on Litoxetine (IXA-001)
Ixaltis is launching its first phase II clinical study with Litoxetine, and has obtained approval from European Health Authorities through the Voluntary Harmonization Procedure (VHP), which will be followed by national authority and ethics approval is France, UK and Poland, and has also obtained approval from Health Canada and Canadian Central Ethics Committee and Health Authorities and Ethics Committee in Georgia to start. The study will include 240 Female subjects aged 18 to 75 years suffering from mixed urinary incontinence, a condition for which there is no successful treatment, from 25 centres in six countries (Canada, France, Georgia, Ukraine, United Kingdom and Poland). The first patient, from Georgia, has entered the study.
Efficacy of the treatment will be assessed by reduction in numbers of urinary incontinence episodes, the change in Patient Perception of Bladder Condition (PPBC), and the Patient Global Impression of Improvement (PGI-I questionnaires, as well as other). The safety and tolerance of Litoxetine compared to placebo will be also estimated.
If successful, this study will pave the way for further development of litoxetine, with the ultimate goal to bring the first medical treatment to patients suffering from mixed urinary incontinence.
Professor François Haab, an urologist surgeon specialized in functional urology and in particular in the treatment of the urinary incontinence of men and women, will be the principal / coordinating investigator of this study as medical expert.
For more information: http://www.ixaltis.com