Biotechnology company Infectex (resident of the Skolkovo Foundation Biomed Cluster, a portfolio company of Maxwell Biotech Venture Fund) has announced positive results of phase 2b-3 associated with clinical trials of the drug SQ109 for the treatment of pulmonary multidrug-resistant tuberculosis (MDR-TB). Now, this brand new drug which is unparalleled in the world is pending registration with subsequent release into production.
SQ109 is a Russian-American development. It belongs to a class of small molecules that were discovered by scientists of Sequella, Inc. (USA) and National Institutes of Health, USA. The drug was created by the Russian company Infectex based on the license for development and commercialization in Russia and CIS countries.
One hundred forty patients completed a six-month active therapy course in a prospective, randomized, double-blind, placebo-controlled study at 7 Russian clinical centres. Both cohorts of patients who received SQ109 treatment regimens (ITT, “Intent to treat”, and PP, “Per Protocol”) showed statistically significant improvement.
Sergey Borisov, Professor, Deputy Director for Scientific and Clinical Work of the Moscow Municipal Scientific and Practical Centre for Tuberculosis Control of the Department of Health of Moscow, chief researcher:
“The test proved that by the end of the sixth month, in combination with standard therapy, the frequency of cessation of bacterial excretion in SQ109 PP group increased to 80% compared with the standard therapy regimen plus placebo (61%). It is equally important that SQ109 demonstrated its safety and high tolerability.”
Dr. Carol A. Nacy, CEO, Sequella:
“We are delighted that Infectex has successfully completed this challenging research. SQ109 has potential to become both a component of standard therapy and a part of the new regimen for tuberculosis treatment.”
Kirill Kaem, Vice-President, Executive Director of Biomedical Technologies Cluster, Skolkovo Foundation:
“Development of a new drug to treat TB is a significant task for applied healthcare. Over the last forty years we saw only one new drug to treat TB, and the existing medicines show high resistance in patients. The Skolkovo Foundation and patients are looking forward to see the new drug SQ109 in the market”.
Dmitry Popov, Managing Partner, Maxwell Biotech Venture Fund:
“Our goal is to bring the drug to patients as soon as possible in order to increase treatment efficacy and to save thousands of lives not only in Russia, but also in the world.”