Canadian-based pharmaceutical company Antibe Therapeutics has successfully completed its Phase II clinical trial of ATB-346 to treat osteoarthritis (OA).
ATB-346 is a non-steroidal, anti-inflammatory drug (NSAID) consisting of a hydrogen sulfide-releasing derivative of naproxen, which has been validated as gastrointestinal-safe derivative of aspirin.
The Phase II clinical trial involved 12 patients with OA of the knee who were administered with 250mg of ATB-346 for ten days on a daily basis.
The ATB-346 dosage contained one-sixth of the typical daily dose of naproxen generally used to treat OA.
The patients kept a record of the intensity of their pain before starting the study and on the fourth and the tenth day of the treatment.
The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain scale, which is considered as the gold standard in arthritis clinical trials, was used to measure the benefit offered by ATB-346.
The dosage was proven effective in reducing pain and exhibited equal or better therapeutic ability than the existing treatment of naproxen or celecoxib.
The drug had also demonstrated safety and tolerability after being administered to the patients.
Antibe chief scientific officer John Wallace said: “In this trial, a once-daily dose of ATB-346 produced a reduction of the WOMAC pain score of 4.3 units on day four, increasing to 7.6 units on day ten, with a very high level of statistical significance in comparison to baseline pain (p<0.001).
“The enhanced effectiveness of ATB-346 as compared to the market-leading drugs for osteoarthritis was a pleasant surprise, particularly considering the low dose of ATB-346 that was used.”
According to Antibe CEO Dan Legault, the company is planning to undertake clinical trials to test the efficacy of ATB-346 against OA while being administered in lower dosages.