March 21, 2017
Infectex Announces Positive Phase 2b-3 Clinical Trial Results of SQ109 for the Treatment of Multidrug-Resistant Pulmonary Tuberculosis
Moscow, Russia and Rockville, MD, USA -- Infectex Ltd., a Russian portfolio company of Maxwell Biotech Venture Fund (MBVF), today announced positive results of a Phase 2b-3 clinical study of SQ109 added to the standard drug therapy regimen in patients with multidrug-resistant pulmonary tuberculosis (MDR-TB). SQ109 is a new small molecule drug discovered by scientists at Sequella, Inc. (USA) and the US National Institutes of Health.
A total of 140 patients were enrolled in a prospective, randomized, double-blind, placebo-controlled study conducted in 7 clinical centers in Russia. The main objective of the study was to assess efficacy, safety, and tolerability of SQ109 in combination with a standard regimen for MDR-TB treatment. Both the Intent to Treat (ITT) and Per Protocol (PP) patients treated with SQ109-containing regimens showed statistically significant improvement in clearance of lung bacteria.
“The sputum culture conversion rate (cessation of Mycobacteria excretion) of PP patients treated with SQ109 plus the standard regimen was 80%, significantly higher than patients treated with the standard regimen plus placebo (61%) by the end of 6 months of treatment,” said Prof. Sergey Borisov, M.D., Deputy Director for Scientific and Clinical Work of Moscow City Research and Practical Center for Tuberculosis Control, principal study investigator, “Furthermore, SQ109 was both safe and well tolerated.”
“We are delighted that Infectex has successfully completed this important study. SQ109 has the prospect of becoming both a part of a new tuberculosis regimen and a component of standard treatment”, said Dr. Carol A. Nacy, CEO of Sequella.
“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”, said Dmitry Popov, Managing Partner of MBVF.