MerLion Pharmaceuticals Announces Successful FDA Type C Meeting for the Systemic Application of the Antibiotic Finafloxacin Against Infections caused by Burkholderia pseudomallei (Melioidosis)

MerLion Pharmaceuticals GmbH (MerLion), a pharmaceutical company focused on the development of novel antibiotics, reported the receipt of the final meeting minutes from the U.S. Food and Drug Administration (FDA) following a successful Type C meeting with the Agency on the development of the antibiotic finafloxacin for the treatment of melioidosis, in a naturally occurring as well as a biodefense context.

"FDA provided clear guidance and considered the program outlined by MerLion for the development of finafloxacin towards potential licensure for the treatment of infections caused by Burkholderia pseudomallei - for both a naturally occurring and biodefense-related melioidosis indication - feasible," said Dr. Andreas Vente, Managing Director of MerLion Pharmaceuticals GmbH. "The melioidosis market authorizations would be based on an NDA for the treatment of a further, though more common, infectious disease of unmet medical need requiring hospitalization," Dr. Vente stated further.

"MerLion Pharmaceuticals is in particular looking forward to continuing the collaboration with its partners from the UK`s Defence Science and Technology Laboratory (Dstl). The success of this collaboration has been and will continue to be instrumental in establishing finafloxacin as a treatment against B. pseudomallei infections, and wouldn’t have been possible so far without key funding by the U.S. Defense Threat Reduction Agency (DTRA) under project HDTRA1-12D-0003-0019," Dr. Vente expressed.

Melioidosis ("Whitmore`s disease") is a serious, often lethal infection caused by the Gram-negative bacterium B. pseudomallei, which is found in subtropical and tropical areas of the world. In 2022 the U.S. Centers of Disease Control and Prevention (CDC) announced melioidosis was endemic in parts of the southern, continental United States. Four unrelated melioidosis cases reported in the United States in 2021, caused by contaminated, imported aromatherapy sprays, further highlight the danger of B. pseudomallei as a potential biothreat pathogen.