Proof-of-concept trials evaluating fosmidomycin-piperaquine therapy are scheduled to start in Thailand this year.
German biopharma firm Jomaa Pharma is teaming up with Medicines for Malaria Venture (MMV) for the clinical development of its antimalarial drug candidate fosmidomycin. Jomaa is developing fosmidomycin primarily as a component in non-artemisinin-based combination therapy (NACT) for the treatment of P. falciparum malaria. The firm says a proof-of-concept study combining fosmidomycin in combination with piperaquine is scheduled to start in Thailand later this year. This study will be followed by Phase II studies in children and toddlers in sub-Saharan Africa.
The collaboration with MMV has been triggered by reports of the emergence of artemisinin resistance on the Thai-Cambodian border, Jomaa explains. “We are also collaborating with the European and Developing Countries Clinical Trials Partnership (EDCTP) to develop NACT products based on fosmidomycin under an existing contract,” notes David Hutchinson, M.D., Jomaa’s managing director.
Jomaa is owned by life sciences financial, consulting, and brokering services organization BioAgency. The firm has commercial rights to a drug combination, Fosclin™, which combines fosmidomycin and clindamycin. Jomaa says both substances have been evaluated separately and as a combination in man, with Phase II combination studies showing encouraging results in terms of high efficacy versus low adverse effects.
Fosmidomycin was originally isolated in the 1970’s by Fujisawa Pharmaceuticals, as a naturally occurring antibiotic produced by Streptomyces lavendulae. The molecule was originally investigated in Phase II studies as a potential treatment for urinary tract infections but was not taken any further for this indication. Jomaa claims its collaborative research subsequently demonstrated that fosmidomycin acts through inhibition of the biosynthesis of isoprenoids through blockade of a metabolic pathway on which the malaria parasite is dependent.