Russian biotechnology company Infectex has reported positive results from a Phase IIb-III clinical trial of SQ109 to treat patients with multidrug-resistant pulmonary tuberculosis (MDR-TB).
Discovered by scientists at US anti-infectives firm Sequella and the National Institutes of Health (NIH), SQ109 is a new 1,2-ethylene diamine small molecule drug.
Results from the trial showed that patients in both the intent to treat (ITT) and per protocol (PP) experienced statistically significant improvement in clearance of lung bacteria.
The prospective, randomised, double-blind, placebo-controlled Phase IIb-III trial evaluated the efficacy, safety and tolerability of SQ109 combined with a standard regimen in 140 patients in seven clinical centres in the country.
Sequella chief executive officer Dr Carol Nacy said: "Now our goal is to bring the product to patients as soon as possible to increase the effectiveness of treatment and save thousands of lives of patients with tuberculosis not only in Russia, but also throughout the world."
It was found that the sputum culture conversion rate of PP patients was 80% by the end of six months treatment period, which is significantly higher compared with patients treated with the standard regimen and placebo combination.
In 2011, Infectex licensed the rights to develop and commercialise SQ109 from Sequella in the Russian Federation and Commonwealth of Independent States.
Currently, the product is under Sequella's US investigational new drug (IND) and has undergone three Phase I trials in the US and two Phase II trials in drug-sensitive TB patients in Africa.
Image: TB causing bacteria found in sputum. Photo: courtesy of TimVickers.