A formulation of AbbVie’s blockbuster wrinkle treatment, acquired through its buyout of Allergan, has failed a mid-stage trial as a potential fix for overactive bladder and urinary incontinence.
The FDA in 2013 approved the use of onabotulinumtoxinA (Botox) via injection into the bladder as a treatment for overactive bladder in adults who can’t take or whose condition doesn’t respond to anticholinergic medications. In 2016, Allergan struck a deal with UroGen Pharma (NASDAQ: URGN) that gave it rights to the biotech’s reverse-thermal hydrogel, or RTGel, technology to test in combination with Botox and other toxins produced by the Clostridium family of bacteria. The gel is meant to extend the length of exposure patients get to existing drugs and by doing so, potentially make local delivery of therapies more effective.
On Thursday Princeton, NJ-based UroGen said the first experimental therapy the companies jointly created, which is administered via catheter, did not meet a Phase 2 study’s main goal of reducing episodes of urgency incontinence. Some patients with overactive bladder, which is characterized by frequent and sudden urges to urinate, experience such episodes.
The potential of so-called Botox therapeutics was among the drivers of the AbbVie (NYSE: ABBV) tie-up with Allergan, according to a 2019 investor presentation. The segment was highlighted as one of five growth assets the company would bring to its acquirer, trailing only its medical aesthetics offerings.
UroGen asserted that preliminary data, which it did not make public, reflects the active ingredient’s failure to permeate the urothelium—the tissue that lines the lower urinary tract, including the bladder.
“In our own research experience, we have clearly demonstrated the ability of RTGel to successfully deliver active molecules to the urothelium resulting in a therapeutic effect,” said Mark Schoenberg, UroGen’s chief medical officer, in a prepared statement.
UroGen said the combination was well tolerated compared to a placebo, and that its gel, as anticipated, extended the drug’s “dwell time” for up to 10 hours. A full evaluation of the results is underway, and that their exploration of combinations of the UroGen tech and toxin proteins owned by AbbVie will continue, the smaller company said. Shares UroGen fell nearly 11 percent Thursday, slipping under $20 for the first time since April to close at $19.86.
Earlier this year UroGen received FDA approval for its first drug, a formulation of mitomycin (Jelmyto) for patients with low-grade urothelial cancer of the upper urinary tract, a form of bladder cancer. Now the company is poised to move a second investigational treatment that uses the RTGel technology, UGN-102, into late-stage testing in patients with low-grade non-muscle invasive bladder cancer in patients at intermediate risk for recurrence and progression. The drugs under development by the New Jersey firm, which also has operations in Israel, are intended to provide a non-surgical option for treating forms of bladder cancer and urologic disease.
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