IXALTIS has already in-licensed, with an exclusive worldwide deal, three molecules from SANOFI, IXA-001, IXA-002, and IXA-003.
Litoxetine (IXA-001) is a selective serotonin (5-HT) reuptake inhibitor (SSRI) and mixed serotonin agonist-antagonist which will be taken in capsules twice a day. SSRIs affect the chemicals that nerves in the brain use to send messages to one another.
These chemical messengers, called neurotransmitters, are released by one nerve and taken up by other nerves.
Neurotransmitters that are not taken up by other nerves are taken up by the same nerves that released them. This process is termed « reuptake. » SSRIs work by inhibiting the reuptake of serotonin, an action that allows more serotonin to be available to be taken up by other nerves.
In addition to these effects, litoxetine has a direct agonist or antagonist effect on specific subtypes of serotonin receptors which makes it particularly appropriate for treating continence dysfunctions.
Scientific data suggests that serotonin is involved in the control of micturition and continence, and this study explores if the specific actions of litoxetine on the serotoninergic system can improve urinary continence.
Indications: Mixed Urinary Incontinence (UI) in women .
March 2017 – 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 in 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.
For more information:
IXA-002 and IXA-003
IXA-002 is an MAO A-B inhibitor. IXA-003 is an MAO B inhibitor. Both products were previously studied through Phase I. Additional preclinical proof of concept is anticipated for 2017 in urological disease models.