Infectex Receives Russian Regulator’s Approval to Conduct Pivotal Clinical Trial for Sequella’s Antibiotic, SQ109, for Tuberculosis

SQ109 will be evaluated for efficacy on multi-drug resistant patients

Infectex has recently received notification from the Russian Ministry of Health for approval to begin the pivotal clinical trial associated with a drug registration submission, and can now proceed with the clinical development of SQ109 for treatment of tuberculosis (TB) in the Russian Federation.

A resident of Skolkovo Biomedical Cluster  Infectex invested by Maxwell Biotech Venture Fund, created with the participation of RVC, is engaged in the development of drug SQ109 with U.S. biotech company Sequella. This drug candidate is a is a low-molecular ethylene diamine compound, that inhibits the enzymes involved in the synthesis of mycobacterial cell wall – unique among anti-TB drugs mechanism of action.

The pivotal clinical trial financed by Maxwell Biotech Venture Fund will be conducted in multi-drug resistant (MDR)-TB patients at TB centers in three major Russian cities (Moscow, Saint-Petersburg and  Ekaterinburg) and will be managed by Infectex.

“We are extremely pleased that our corporate partner has achieved regulatory clearance to allow further study and potential commercialization of SQ109 in patients desperate for new therapeutic options,” said Dr. Carol Nacy, CEO of Sequella. “We congratulate Infectex on this success, and we look forward to the future availability of SQ109 to improve the lives of patients suffering from MDR-TB.”

According to the World Health Organization (WHO), Russia is one of the world’s “high burden” TB countries, with over 150,000 cases of active TB reported each year and over 43,000 cases of MDR-TB. In parts of Russia and the CIS, TB infection rates are over 3 times that which the WHO considers epidemic, prompting the Russian government to make TB control a top priority. The Russian market for anti-tubercular drugs is well over $150 million per year, with total TB control costs estimated to be well over $1 billion.

“We are very glad to participate in this international project in close cooperation with our partners from Maxwell Biotech Venture Fund and Sequella and hope that a new drug candidate will strengthen the efficiency of the existing treatment regimens and will be able to improve Russian and global standards of care in the future”, said Prof. Sergey Borisov, chief study coordinator, deputy director for science and clinical work at Moscow Research Center for TB control of the Moscow Department of Health.

 

Anna Zelenkova,
PR manager at Maxwell Biotech Group;
Tel.: +7 (495) 411-6992
E-mail: zelenkova@maxwellbiotech.ru