AltheRx Pharmaceuticals, a privately-held clinical development company, today announced the United States Patent and Trademark Office issued a Notice of Allowance for the company's U.S. Patent Application claiming a method of use for solabegron, a beta 3-adrenergic receptor agonist, in combination with all commercially available antimuscarinics at both therapeutic and sub-therapeutic doses for the treatment of overactive bladder (OAB). Upon issuance, the patent will provide AltheRx a strong position through the early 2030s.
"The grant of this patent is transformational for AltheRx," said Jim Bennethum, Chief Executive Officer of AltheRx. "Data indicates that the combination of solabegron and antimuscarinics has a synergistic effect on the bladder. This effect has the potential to improve treatment outcomes and satisfy the unmet needs of millions of patients suffering from OAB symptoms."
According to Roger R. Dmochowski, M.D., Department of Urology, Vanderbilt University, "Clinical data indicates that solabegron has the potential to become a highly effective and competitive mono-therapy that does not have the dry mouth and constipation complications evident in many current treatments. AltheRx's discovery of the synergy created by the combined use of solabegron with an antimuscarinic is significant because it holds the promise of a new standard of pharmaceutical treatment for overactive bladder."
AltheRx is currently developing solabegron, a novel beta 3-adrenergic receptor agonist with high affinity and selectivity, for the treatment of OAB. Phase II clinical results demonstrated a statistically significant improvement with solabegron as compared to placebo, with favorable tolerability. Solabegron is poised to enter Phase III clinical studies in the EU and the US and AltheRx is in active business development discussions to progress the drug through late stage clinical development and eventually into global commercialization.
"AltheRx discovered that combining solabegron with existing antimuscarinics, whether in therapeutic or sub-therapeutic doses, generates a breakthrough level of effectiveness while improving the tolerability of the treatment," said Dr. Eliot Ohlstein, AltheRx Chief Scientific Officer and Head of R&D.
"This addition to our IP portfolio uniquely positions AltheRx to deliver the benefits of a fixed dose combination to underserved patients with OAB and substantively improves the solabegron value proposition," concluded Mr. Bennethum.