Infectex, a resident of the Skolkovo Foundation’s biomed cluster, has completed clinical trials in Russia of its new drug for treating TB, the company announced on Friday, World Tuberculosis Day.

The drug – SQ109 – has demonstrated high efficacy against pulmonary multiple drug-resistant strains of TB-causing mycobacteria, and is now pending registration, the company said in a press release.

Infectex's TB drug, SQ109, can now be registered as a medicine and produced for sale in Russia. Photo: Infectex.

In the recently completed phase 2b-3 of the clinical trials, 140 patients completed a six-month active therapy course in a prospective, randomized, double-blind, placebo-controlled study at seven Russian clinical centres. Both cohorts of patients who received SQ109 treatment regimens – intention to treat (ITT) and per-protocol (PP) – showed statistically significant improvement.

“The test proved that by the end of the sixth month, in combination with standard therapy, the frequency of cessation of bacterial excretion in the SQ109 PP group increased to 80 percent, compared with the standard therapy regimen plus placebo (61 percent),” said Professor Sergei Borisov, the project's chief researcher and deputy director for scientific and clinical work of the Moscow Municipal Scientific and Practical Centre for Tuberculosis Control within the Moscow health department.

“It is equally important that SQ109 demonstrated its safety and high tolerability,” he said.

The drug has also completed three clinical trials in the U.S. and two in Africa, and the trials there are ongoing. In the United States, SQ109 has the status of an Investigational New Drug (IND).

“Development of a new drug to treat TB is a significant task for applied healthcare,” said Kirill Kaem, head of the Skolkovo Foundation’s biomed cluster.

“Over the last 40 years we have seen only one new drug to treat TB [before SQ109], and the existing medicines show high resistance in patients,” said Kaem.

An estimated 60,000 cases of multiple drug-resistant TB a year do not respond to standard TB drug treatment, and it is projected that up to 70 million people could die of TB in the next three decades, according to Sequella, Inc., a private U.S. company developing new drugs to treat antibiotic-resistant infections.

SQ109 is a Russian-U.S. development that belongs to a class of small molecules that were discovered by scientists at Sequella together with National Institutes of Health, part of the U.S. Department of Health. Sequella granted Infectex – which is also working on developing another anti-TB drug, Q203 – the rights to develop and commercialise SQ109 in Russia and the Commonwealth of Independent States back in 2011.

Russia is among the 27 high multidrug-resistant tuberculosis burden countries in the world, according to the World Health Organization, with an estimated 42,000 cases recorded in 2015, the last year for which data is available. The disease is particularly rife in Russian prisons, which are home to 14 percent of the country’s TB patients, according to the Federal Penitentiary Service. 

SQ109 enhances the activity of anti-TB drugs, such as isoniaside, rifampicine and bedaquiline, and shortens by over 30 percent the time required to cure experimental tuberculosis in mice. SQ109 could replace one of several currently used anti-TB drugs, simplify therapy, and shorten the treatment period, its makers say.

Dr. Carol A. Nacy, CEO of Sequella, said her company was delighted that Infectex had successfully completed the challenging research.

“SQ109 has the potential to become both a component of standard therapy and a part of the new regimen for tuberculosis treatment,” she said.

“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 around the world,” said Dmitry Popov, a managing partner at Maxwell Biotech Venture Fund, of which Infectex is a portfolio company.