Affinium Pharmaceuticals, Ltd. Announces the Initiation of an Oral, Multiple-Ascending-Dose Phase I Clinical Trial of AFN-1252, its Novel Anti-staphylococcal Antibiotic
Austin, Texas, October 12, 2010 — Affinium Pharmaceuticals announced today the clinical completion of the first of three cohorts in a multiple-ascending-dose Phase I study in the United States for its novel, selective-spectrum, anti-staphylococcal agent, AFN-1252. Preliminary results in terms of safety and pharmacokinetics are excellent. This study follows the successful performance of a new, optimized oral tablet formulation of AFN-1252 in a single-ascendingdose study conducted earlier this year.
"We were very pleased with the safety and pharmacokinetic performance from the single-ascending dose study using the new oral formulation of AFN-1252, and we are very excited to be moving forward to the next stage of trials," commented Dr. Barry Hafkin, Chief Medical Officer of Affinium Pharmaceuticals. "Tolerability and safety in both the single dose study and the initial cohort of our multiple dose study have met our high expectations, and studies to date support moving ahead with the development of AFN-1252 as a potent once-a-day therapeutic."
Dr Nachum Kaplan, Vice President of Microbiology added that "Clinical results continue to support our premise that a highly-potent, selective-spectrum antibiotic would have fewer adverse events than typical broad-spectrum agents, and also continue to show AFN-1252 exposure levels that support once a day oral dosing. We’re excited about the opportunity for AFN-1252 to be perceived as the best-in-class, selective-spectrum agent to treat staphylococcal infections."
Oral MAD studies are expected to be completed by year end.
About Affinium Pharmaceuticals
Affinium Pharmaceuticals is a specialty pharmaceutical company focused on discovery and development of novel anti-infective medicines. The Affinium FASII antibacterial programs constitute a new antibiotic franchise with the potential for multiple products targeting the FASII pathway. These programs include a broad base of long-term intellectual property: issued and pending composition of matter patents on potent orally available small molecule inhibitors of a new class of antibiotics with a unique mechanism of action, targeting an underexploited pathway.
About AFN-1252
AFN-1252, the lead clinical candidate from Affinium’s FASII program, is designed to selectively target the staphylococcal FabI enzyme. AFN-1252 provides exceptional nanomoler potency against all drug-resistant phenotpyes of staphylococci, including hospital- and community-acquired methicillin-resistant Staphylococcus aureus (MRSA) and coagulasenegative staphylococci. Extremely low propensity for microbial resistance development has been observed in microbiological studies. The antibiotic has also shown excellent in vivo efficacy in animal models of infection. Oral bioavailability and excellent safety & tolerability have been demonstrated in three previous Phase 1 single dose clinical trials and in human microdosing studies. An injectable formulation is advancing through pre-clinical development.
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