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news.Debiopharm Group and Affinium Pharmaceuticals have announced the acquisition by Debiopharm of Affinium's clinical and preclinical assets as well as its technology platform to identify and develop targeted antibiotics.
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The clinical assets include AFN-1252, a FabI inhibitor designated by the FDA as a Qualified Infectious Disease Product (QIDP) which has successfully completed a Phase 2a study for the treatment of acute bacterial skin and skin structure infections (ABSSSI), and its prodrug AFN-1720, currently in Phase 1 clinical development.
Both compounds are highly potent agents that are selectively active against all Staphylococcus species and strains tested thus far (5400 strains) including all known resistant strains such as methicillin-resistant S. aureus (MRSA) and vancomycin-intermediate S. aureus (VISA).
In clinical trials, AFN-1252 has demonstrated an excellent efficacy, safety and tolerability profile in over 250 subjects.
The possibility to treat staphylococcal infections with a molecule that allows for an intravenous-oral switch will be a major advance to address difficult-to-treat infections.
Through its expertise of molecular diagnostics, Debiopharm will develop concomitantly with the clinical trials a diagnostic test that will allow to select Staphylococcus-infected patients, and increase the success of treatment.
"This acquisition is a strategic choice for Debiopharm and represents a massive continuing investment in antibiotic development. In September 2013, we entered the antibiotics arena by signing an agreement with TCG Life Sciences Ltd (India) to develop a novel class of antibiotics," said Thierry Mauvernay, Delegate of the Board of Debiopharm Group.
"In 2013, the scientific community has shown that the gut microbiome plays vital roles in determining how the body responds to challenges as different as malnutrition, autoimmune diseases and cancer. Thus, as highlighted in the 2013 Science Breakthrough of the Year, 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".
"The purchase of Affinium’s assets is a unique opportunity to develop a targeted antibiotic having demonstrated excellent efficacy and safety in clinical trials as well as the potential to preserve gut flora diversity and thus to prevent acquired resistance. We are very happy about this achievement and are confident that Affinium’s novel platform will yield additional, new, first-in-class antibiotics in the near future," commented Andres McAllister, Chief Scientific Officer, Debiopharm International SA.
"We are delighted to transfer the subsequent development of Affinium’s clinical lead antibiotic, AFN-1720, as well as the promising platform in selective antibiotics, to our colleagues at Debiopharm, stated Ed Mascioli, MD, CEO of Affinium.
"We wish them every success in bringing AFN-1720 through regulatory approvals to serve the serious medical needs of an increasing patient population suffering from life-threatening Staphylococcal infections. We look forward to Debiopharm’s unlocking the very promising potential of the platform in generating more specific, targeted antibiotics against other serious infectious pathogens. We are also very pleased that Drs. Nachum Kaplan and Barry Hafkin will continue with the program’s development. Their collective decades of expertise in microbiology and infectious diseases as well as with this program will ensure its future success."