Affinium Pharmaceuticals, Ltd. Announces the Initiation of a Phase I Clinical Trial Using an Optimized Oral Formulation of AFN-1252, its Novel Anti-staphylococcal Antibiotic
Austin, Texas, April 9, 2010 — Affinium Pharmaceuticals announced today the commencement of a Phase I study in the United States for its novel molecular entity, AFN-1252 , a first in class antibiotic candidate focused on the oral and IV treatment of susceptible and highly resistant strains of Staphylococcus aureus ( MRSA). The study will evaluate the safety and tolerability of a new, oral tablet formulation.
Dr. Barry Hafkin, Chief Medical Officer of Affinium Pharmaceuticals, noted , "We have previously documented good oral bioavailability and excellent tolerability of the drug candidate in two previous clinical studies using simple oral formulations, and we are very pleased to move a newly developed oral formulation that we expect will optimize the pharmacokinetic profile of AFN-1252. We anticipate that the trial will be completed in the third quarter of this year, and that AFN-1252 will continue to demonstrate the excellent tolerability and safety seen in previous studies."
About Affinium Pharmaceuticals
Affinium Pharmaceuticals is a specialty pharmaceutical company focused on the discovery and development of novel anti-infective medicines. Affinium's 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 FabI enzyme found in staphylococci. AFN-1252 provides exceptional potency against all drug-resistant phenotpyes of staphylococci including hospital- and community-acquired methicillin-resistant Staphylocuccus aureus (MRSA) and coagulasenegative staphylococci. Extremely low propensity for microbial resistance development has been observed in microbiological studies. Oral bioavailability and excellent safety & tolerability have been demonstrated in two previous Phase 1 clinical trials and in human microdosing studies. The antibiotic has also shown excellent in vivo efficacy in animal models of infection. An injectable formulation is in pre-clinical development.
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