SQ109 is currently undergoing Phase II evaluation in Africa and Phase I studies in the U.S.
Maxwell Biotech Venture Fund negotiated a license to develop and commercialize Sequella’s Phase II antibiotic SQ109 for the treatment of tuberculosis (TB) in the Russian Federation and neighboring Commonwealth of Independent States (CIS) countries. Under terms of the deal Sequella could earn up to $50 million in payments resulting from an equity investment by Maxwell, the supply of clinical trials materials, milestones, and future royalties.
SQ109 is Sequella’s lead compound. It is an orally active small molecule that besides TB is also being tested in Helicobacter pylori-related duodenal ulcers and carcinomas. Additionally, the drug is in preclinical development against Candida glabrata.
Phase II trials in Africa for the TB indication are ongoing along with Phase I studies in the U.S. Earlier this month Sequella reported the award of two NIAID grants to fund the planning of Phase III studies. The money was also to be used to develop clinical sites in Russia, CIS territories, and Eastern Europe, for evaluating SQ109 in multidrug resistant tuberculosis (MDR-TB) and to investigate a new drug target in Mycobacterium tuberculosis.
SQ109 was discovered by scientists at Sequella and the NIAID working under a CRADA. Sequella claims the drug has a mechanism of action that is distinct from other antibiotics used against TB. SQ109 is in addition active against both drug-susceptible and multidrug-resistant bacteria including XDR-TB strains and has been shown to boost the activity of antitubercular drugs including isoniazid and rifampin, Sequella claims.
Use of SQ109 has been shown to reduce the time needed to cure TB in animal models by over 30%, the firm adds. The drug has been granted fast track designation by FDA for the TB indication and has orphan drug designation in the U.S. and EU.
Earlier in April Sequella was awarded a $3.8 million, five-year grant from the NIAID to fund the identification and early development of new ethylenediamine-based antibiotics against Clostridium difficile. Sequella chemists will collaborate with microbiologists at the University of Virginia to identify highly active chemical analogs of SQ109 that are effective against C. difficile. The grant will support acquisition of all nonclinical data required to advance a lead drug candidate to IND-directed preclinical studies.