Debiopharm Group™ will buy Affinium Pharmaceuticals’ clinical and preclinical antibacterial compounds and its technology platform, which is intended to identify and develop targeted antibiotics, for an undisclosed price, the companies said today.
The deal comes just five months after Debiopharm expanded into antibiotic drug development. In September 2013, Debiopharm signed an agreement with India’s TCG Life Sciences to develop a new class of antibiotics.
“This acquisition is a strategic choice for Debiopharm and represents a massive continuing investment in antibiotic development,” Thierry Mauvernay, delegate of the board of Debiopharm Group, said in a statement. “We are convinced that it is crucial to develop innovative targeted antibiotics which preserve indigenous gut microbiota and overcome resistance to broad-spectrum antibiotics. Debiopharm intends to make additional investments in this promising field and become a key player in this therapeutic area and associated diagnostics.”
Clinical assets acquired by Debiopharm include AFN-1252, a FabI inhibitor that has successfully completed a Phase IIa study for the treatment of acute bacterial skin and skin structure infections (ABSSSI). In clinical trials, AFN-1252 has demonstrated efficacy, safety, and tolerability in more than 250 subjects. AFN-1252 has been designated by the FDA as a qualified infectious disease product (QIDP), which entitles developers to faster agency reviews and five additional years of market exclusivity.
AFN-1252 and its prodrug AFN-1720, another Debiopharm-acquired clinical compound, are selectively active against all roughly 5,400 Staphylococcus species and strains tested thus far, including all known resistant strains such as methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA). Now in Phase I development, AFN-1720 is expected to preserve the human gut microbiota resulting in minimal antibiotic-associated side-effects, such as antibiotic-induced diarrhea or C. difficile overgrowth.
Clinical data observed to date strongly support that expectation, according to Debiopharm, which adds that no resistance pressure on other bacterial species, the development of multiple drug-resistant organisms such as ancomycin-resistant enterococci (VRE) is unlikely. Oral and IV AFN-1720 formulations are being developed for clinical use in several serious infections.
Debiopharm also said it will develop concomitantly with the clinical trials a molecular diagnostic test that will allow for selection of staphylococcus-infected patients, with the goal of increasing the likelihood of successful treatment. The company reasons that the possibility to treat staphylococcal infections with a molecule allowing for an intravenous-oral switch will be a major advance in addressing difficult-to-treat infections.
As part of the deal, Affinium CMO Barry Hafkin, M.D., and CSO Nachum Kaplan, Ph.D., will continue with development of the antibiotic program after its acquisition by Debiopharm, “Their collective decades of expertise in microbiology and infectious diseases as well as with this program will ensure its future success,” said Affinium CEO Ed Mascioli, M.D.
Founded in 1979, Debiopharm is a global biopharmaceutical group of four companies specializing in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments. The drug development company focuses on infectious disease treatments as well as treatments for immunology and metabolism indications.