Ixaltis has raised €8 million ($8.9 million) to take the ex-Sanofi ($SNY) compound litoxetine through a Phase II trial. The genitourinary specialist, which lists two former CEOs of Stallergenes (EPA:GENP) among its founders, is looking to demonstrate that the properties that once saw litoxetine trialed as an antidepressant can improve symptoms in people with urinary incontinence.
Roberto Gradnik and Christian Chavy, the two aforementioned ex-Stallergenes CEOs, set up Ixaltis a few years ago with the CEO of preclinical CRO Urosphere and a pair of urology experts. Since then, the company has snagged an exclusive license to litoxetine and two other assets from Sanofi, picked up seed funding and generated data to suggest that it can reposition the candidates as treatments for genitourinary conditions.
The initial focus is on litoxetine, a serotonin reuptake inhibitor and 5-HT3 receptor antagonist that was in development as an antidepressant at Synthélabo prior to its merger with Sanofi in 1999. “We have preclinical evidence that it works for a very specific mechanism of action involving serotonin,” Gradnik, who is serving as CEO of Ixaltis, told FierceBiotech.
Ixaltis isn’t the first company to hit upon the therapeutic idea. In 2004, European regulators approved Eli Lilly’s ($LLY) serotonin and noradrenaline reuptake inhibitor Cymbalta under the brand name Yentreve as a treatment for urinary incontinence. However, Lilly and its ally Boehringer Ingelheim never persuaded the FDA to follow suit, resulting in the partners opting to pull their application for approval in the U.S. in 2005.
Armed with safety data from Sanofi, Ixaltis thinks it can improve on these earlier efforts. Gradnik and his colleagues have convinced IRDInov, iXO Private Equity, and Sofimac Partners of the merits of the idea. The French investment shops joined with Principia and Pierre-Olivier Goineau, the president of France Biotech, for an €8 million round that gives Ixaltis everything it needs to advance to the next step in its evolution.
“We are ready to start Phase II,” Gradnik said. A dose-finding study is first up, with a proof-of-concept trial set to follow in the back half of next year.
While the near-term focus is on litoxetine, Ixaltis has broader ambitions to carve out a niche in the genitourinary sector. The choice of specialization is based, in part, on a belief that the sector is rife with unmet needs. “In our opinion, it has been neglected by pharma companies,” Gradnik said.
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