AltheRx Pharmaceuticals has received a notice of allowance for its patent application from the US Patent and Trademark Office (USPTO) for the use of solabegron, a beta 3-adrenergic receptor agonist, in combination with antimuscarinics at both therapeutic and sub-therapeutic doses, for the treatment of overactive bladder (OAB).
According to the clinical data, the combination of solabegron and antimuscarinics has a synergistic effect on the bladder, as well as has the potential to improve treatment outcomes and satisfy the unmet needs of millions of patients suffering from OAB symptoms.
Vanderbilt University professor of urology Roger Dmochowski said clinical data shows that solabegron has the potential to become a highly effective and competitive mono-therapy.
"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," Dmochowski said.
The company is currently involved in the development of solabegron, a novel beta 3-adrenergic receptor agonist with high affinity and selectivity, for the treatment of OAB patients.
Phase II clinical results showed a significant improvement with solabegron compared to placebo, with favourable tolerability.
Solabegron is mpw ready to enter Phase III clinical trials in the European Union and the US, while the company is in discussions to progress the development of the drug through late stage clinical development and finally into global commercialisation.
AltheRx chief scientific officer Eliot Ohlstein said: "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."
According to the company, Solabegron relaxes the bladder smooth muscle by stimulating beta 3-adrenoceptors, a novel mechanism compared to currently available treatments.
Solabegron, which was originally discovered by GlaxoSmithKline, was later acquired by AltheRx in March 2011.
Solabegron has previously completed and demonstrated positive results in Phase II clinical programs for the treatment of OAB in women and irritable bowel syndrome.
AltheRx believes solabegron has the potential to improve treatment outcomes for OAB patients as well as enhance the value of its IP portfolio.
