Velicept Therapeutics has started a Phase IIb clinical, VEL2002, to evaluate solabegron for the treatment of patients with overactive bladder (OAB).
The trial will include 375 adult women aged between 18 and 80 with signs and symptoms of OAB.
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They will be enrolled from 90 centres across North America and will be given either 125mg or 175mg of solabegron twice daily, or placebo for 12 weeks.
The trial’s primary objective is to analyse the mean change in number of micturitions per day as measured by patients in an e-diary.
Velicept has also finalised a new once-daily formulation of solabegron that will be examined in a second Phase IIb study, VEL2001.
The formulation has been developed to optimise efficacy in a once-daily dosing. The VEL2001 is set to begin enrolling patients in the second quarter of this year.
Velicept Therapeutics president and CEO James Walker said: “Driving the programme forward with the novel once daily formulation of solabegron as well as expanding our intellectual property estate are key steps for Velicept as we work to deliver an optimal therapy to patients suffering from OAB.
“Many patients who suffer from overactive bladder do not achieve adequate relief on existing therapies, so we have designed our development programme to maximise potential treatment options for physicians and their patients.”
Furthermore, Velicept has received a US Patent and Trademark Office (USPTO) patent that allows the use of solabegron to treat OAB.
Solabegron is a selective beta-3 adrenoceptor agonist currently under investigation for OAB and irritable bowel syndrome (IBS).
