Sequella to develop SQ109 further with EDCTP, LMU, and TB experts in PanACEA

Sequella, Inc., a clinical-stage company focused on commercializing novel drugs for treatment of life-threatening infectious diseases, announced it has signed an agreement with the Ludwig-Maximilians-University (LMU) of Munich to coordinate a European Union grant for Phase 2 clinical trials of SQ109 in adult pulmonary tuberculosis (TB) in seven sites in Africa.

“We are excited by the opportunity to work with EDCTP, the LMU, and the very talented group of TB experts in PanACEA to further the clinical development of SQ109.”

The Phase 2 studies, which will support international regulatory submissions, will be performed by the Pan African Consortium for Evaluation of Antituberculosis Antibiotics (PanACEA). The studies will be funded by a €12 million grant by the European and Developing Countries Clinical Trials Partnership (EDCTP) and a €3 million commitment by Sequella for in-kind and corporate funding. The multi-year clinical program will be directed by Professor Michael Hoelscher, Department of Infectious Diseases and Tropical Medicine, University Hospital of LMU, in conjunction with Sequella.

"TB is a global health problem that will only be solved by international cooperation and focus on improvement in patient care," said Dr. Carol A. Nacy, CEO of Sequella. "We are excited by the opportunity to work with EDCTP, the LMU, and the very talented group of TB experts in PanACEA to further the clinical development of SQ109."

PanACEA members include TB experts from six European research institutions, twelve sub-Saharan Africa clinical trial sites, and two pharmaceutical companies. The SQ109 Phase 2 trials will be conducted in clinical sites located in South Africa, Tanzania, Gabon, and Zambia.

"The EDCTP is pleased to have an important role in supporting the development of SQ109, a promising new antibiotic to treat tuberculosis," said Charles S. Mgone, Executive Director, EDCTP. "This is part of the ongoing series of cooperative clinical trials conducted by PanACEA, the EDCTP funded network that aims at simplifying and shortening tuberculosis treatment. We look forward to the results of the clinical studies."

"LMU and PanACEA are enthusiastic to have SQ109 in our drug evaluation portfolio as the preclinical data look very promising." said Michael Hoelscher, PanACEA Chief Investigator. "We are therefore looking forward to start the first SQ109 study in Cape Town before the end of this year."