TorreyPines Therapeutics Inc. (Nasdaq: TPTX) announced Tuesday it has initiated a Phase 2 study as part of its development for a drug to fight a dry mouth disorder.
The company is conducting a randomized, double-blind, placebo-controlled, crossover study with a Latin square design for NGX267, a muscarinic agonist in development for xerostomia, a dry mouth disease often related to the autoimmune disorder Sjogren's syndrome, radiation treatment, HIV, side effects of medications or aging. NGX267 is particularly for xerostomia related to Sjogren’s syndrome.
Approximately 24 patients will be enrolled at three sites in the United States. In four distinct treatment periods, each patient will be randomized to receive a single dose of 10 mg, 15 mg and 20 mg of NGX267 and placebo. The order of treatment is determined by the Latin square design. The primary endpoint of the study is quantitative measure of salivary flow.
"As we previously announced, we are focusing our clinical development activities on maximizing the value of our lead compounds to take advantage of their versatility," said Neil Kurtz, M.D., president and chief executive officer of TorreyPines Therapeutics. "Three Phase 1 studies have already demonstrated the safety and tolerability of NGX267.”
In a Phase 1 multiple-dose study completed in September 2007, salivary flow increased linearly with doses of NGX267, and these increases were maintained over four days of dosing, according to the company.
Stock in TorreyPines Therapeutics remained unchanged at a $1.32 a share in morning trading.