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news.The US Food and Drug Administration (FDA) has accepted Velicept Therapeutics' Investigational New Drug (IND) application to initiate a Phase I pharmacokinetic study for a once-daily formulation for solabegron.
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Solabegron is a highly potent and selective beta-3 adrenoceptor agonist that is being developed for the treatment of overactive bladder (OAB).
Moreover, solabegron has already demonstrated efficacy for the treatment of OAB having met all primary endpoints in a prior Phase II study conducted with the twice-daily formulation. Solabegron has been tested in more than 800 study subjects.
“Since our acquisition of solabegron in the fourth quarter of 2015, we have executed on our plan to optimize the formulation of solabegron into a once-daily dose and we intend to initiate a Phase I study of this novel candidate in OAB this month,” said James C. Walker, Velicept President and Chief Executive Officer.
“Our newly formed seasoned management team and advisory board are excited in the potential for solabegron to offer an improvement in treatment alternatives for this large patient population. Twice-daily solabegron has shown statistically significant improvement over placebo in the first Phase II study for overactive bladder and this enhanced formulation is designed to provide patient convenience as well as further clinical benefit.”
A Phase II study of solabegron in OAB, previously conducted by GlaxoSmithKline, evaluated a twice-daily dose in 258 patients with moderate to severe incontinence experiencing an average of 4.5 wet episodes per day.
Results demonstrated a statistically significant improvement with solabegron as compared to placebo. Furthermore, the Phase II study also indicated a safety and tolerability profile for solabegron that was similar to placebo.