UroGen presses ahead with RTGel after Botox pairing stumbles in overactive bladder trial

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UroGen in April revealed promising interim data from a phase 2 of its RTGel platform plus its investigational drug UGN-102 in bladder cancer patients. (UroGen).

With a recent phase 2 flop for UroGen's hydrogel version of AbbVie's Botox, the biotech may have hit a wall with that particular pairing. But that doesn't mean UroGen has given up on its gel technology's promise for delivering drugs to the bladder.

After making waves earlier this year with the launch of its first drug, Jelmyto—the only approved non-surgical treatment option for a rare form of cancer—UroGen said last week that its reverse thermal hydrogel (RTGel) in combination with Botox failed to curb urinary incontinence episodes in overactive bladder patients.

AbbVie, which ran the phase 2 trial, has yet to release top line data, but suggested the results were linked to Botox's failure to effectively permeate the urothelium, which lines the lower urinary tract. 

The RTGel itself was well-tolerated compared to placebo, and patients reported excreting the gel during urination up to 10 hours after administration, spotlighting the drug's safety and efficacy as an extended-release delivery method for urinary diseases, UroGen CMO Mark Shoenberg, M.D., said in an interview.

The Israeli-New Jersey pharma's polymer-based hydrogel assumes a liquid form when cooled, allowing it to be mixed with drugs. Patients then receive an RTGel treatment via a standard urinary catheter. Once the mixture warms to body temperature, it becomes a soft gel that remains in a body cavity, such as the bladder or kidney, for around six to eight hours, allowing for extended release of drugs, Schoenberg said. 

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While AbbVie has yet to divulge next steps for RTGel with Botox, the company has said it's interested in continuing to combine its suite of protein toxins with UroGen's RTGel delivery platform, Schoenberg added. 

UroGen has also tested the delivery method in combination with the chemo drug mitomycin in patients with low-grade intermediate risk non-muscle invasive bladder cancer.

Urogen in April unveiled interim data from its phase 2 Optima II trial of the combination, dubbed UGN-102, showing that RTGel-delivered mitomycin triggered a complete response in 65%—or 41 out of the 63 patients treated—three months after treatment. The company's now plotting a phase 3 to test it further.

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Urothelial cancers are common, Schoenberg said, citing an estimated 700,000 people in the U.S. walking around with a diagnosis. Those patients are often older, too, with an average age at diagnosis of 74 years. Right now, the main treatment option is surgery, which can be painful and repetitive given the high rate of recurrence. UroGen hopes its RTGel will offer a less invasive option.

Meanwhile, the company scored a win in April with the approval of its first drug, Jelmyto, in upper tract urothelial cancer (UTUC)—the first non-surgical option approved to treat the disease. It typically requires multiple surgeries, including kidney removal, an especially risky option for UTUC patients, who are often over the age of 70. 

For Jelmyto's June 1 launch, UroGen built out a team of 48 sales staff and embraced digital communication to chat virtually with physicians who treat UTUC.