Russian company Infectex has announced the completion of clinical trials of SQ109, a world-unique drug to treat TB
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.
Infectex TB drug
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.”
For reference
About SQ109
SQ109 is a brand new anti-TB drug. It is a small molecule (1,2-Ethylenediamine), which has three unique mechanisms of action different from the mechanisms of action of other antibiotics used for tuberculosis treatment. In laboratory studies, SQ109 demonstrated high efficacy against tuberculosis-causing mycobacteria, both drug sensitive and having multiple drug resistance including extensive drug resistance.
SQ109 enhances the activity of anti-TB drugs, such as isoniaside, rifampicine and bedaquiline, and shortens by over 30% the time spent for curing experimental tuberculosis in mice. SQ109 could replace one or several currently used anti-TB drugs, simplify therapy, and shorten the treatment period. In 2011, Infectex licensed the rights to develop and commercialize SQ109 in Russia and CIS from Sequella. In the United States, SQ109 has the status of an Investigational New Drug (IND). In addition to studying the 2b-3 phase in Russia, there were completed three studies of the drug in the United States (phase 1) and two studies in Africa for patients with tuberculosis caused by anti-TB drug-sensitive mycobacteria (phase 2).
About Infectex
Infectex LLC (Moscow, Russia) is a biotechnology company founded in 2011 with the aim of developing and introducing on the Russian market the drugs for MDR-TB treatment. Currently, the company is developing two anti-TB drugs: SQ109 and Q203. Infectex is a resident of the Skolkovo Foundation Biomed Cluster.
www.infectex.com
About Sequella
Sequella (USA) is a private company engaged in the development of brand new drugs for antibiotic-resistant infections treatment. The company was founded 19 years ago. It is currently conducting the phase 2 clinical study of a drug against Helicobacter pylori for gastritis treatment and an anti-TB drug, as well as IND preclinical studies of a drug for the treatment of infections caused by Clostridium difficile. Sequella uses its international contacts, research platform and expert position in infectious diseases to actively address emerging health threats. Sequella intends to commercialize a broad portfolio of drugs for the treatment of diseases posing global health threats and having significant market potential. Website: www.sequella.com
Media Contacts:
Alicia Moran, AM Media and Marketing
+1-410-991-7027
aliciamoranmedia@gmail.com
Carol A. Nacy, Ph.D., CEO, Sequella, Inc.
+1-202-321-8178
carolnacy@sequella.com
About Maxwell Biotech Venture Fund
Maxwell Biotech Venture Fund is the first Russian Venture Fund fully focusing on investments in biomedical technology. It was supported by the RVC equity. Portfolio companies of the Venture Fund are developing nine innovative drugs, four of which are now in late stages of clinical development. Website: www.maxwellbio.com
Media Contacts: Edward Kanalosh
+7 (495) 726-52-53
kanalosh@ammaxwell.ru
About the Skolkovo Foundation
The Skolkovo Foundation is a non-profit organization founded in September 2010 by the Russian government with the objective of accelerating Russia’s transformation from a resource-intensive to an innovation-based economy. To achieve this objective, the Foundation is overseeing the creation of the Skolkovo Innovation Center, composed of more than 1,500 high-tech startups, Skolkovo Technopark, the Skolkovo Institute of Technology (Skoltech) - a new graduate research University established in collaboration with the Massachusetts Institute of Technology - and Skolkovo city, located near Moscow. Together, these entities establish a vibrant ecosystem of technology innovation and entrepreneurship. The cumulative revenue of Skolkovo’s startups through June 2016 reached $1,6 billion. They brought in more than $350 million in investment, creating 21,800 jobs and filing over 1,900 patent applications along the way. By 2020 over 2 million square meters of residential and office space will be built in Skolkovo with 35,000 people working daily in the Innovation Center. For more information: http://www.sk.ru/en
Press Contact
Skolkovo
Taisiya Yarmak
+79166948826
tyarmak@sk.ru