Bend Research Inc. (www.bendresearch.com), a leading independent drug-formulation development and manufacturing company, today announced a licensing agreement with Affinium Pharmaceuticals, Ltd. (www.afnm.com).
Bend Research has licensed its proprietary spray-dried dispersion (SDD) technology to the biotechnology firm. The SDD technology, which is used to improve the bioavailability of compounds with low aqueous solubility, has been instrumental in advancing oral formulations of Affinium's promising novel antibiotic, AFN-1252, to Phase 2 human efficacy trials.
"We are excited about this opportunity to strengthen our relationship with Affinium and we'd like to congratulate them on advancing AFN-1252 into Phase 2 clinical studies," said Rod Ray, Bend Research CEO. "This is one more demonstration of the effectiveness of the technologies and tools Bend Research has developed to solve our clients' toughest problems."
In many cases, he said, the SDD technology has proven to be an enabling technology in developing oral dosage forms for difficult-to-formulate compounds.
The licensing agreement is the culmination of a body of work Bend Research performed to ready AFN-1252 oral dosage forms for clinical testing. Bend Research performed feasibility testing, formulation and dosage-form development, and process development, as well as manufacturing clinical supplies of SDD and tablets for the Phase 2 study.
AFN-1252 is the first of a new class of antibiotics being developed by Affinium for the treatment of infections associated with Staphylococcus spp, including methicillin-resistant Staphylococcus aureus (MRSA). Affinium's current Phase 2 study in acute bacterial skin and skin structure infections is the first human efficacy study of this new class of antibiotic. It follows recently completed Phase 1 trials, in which the oral formulation of AFN-1252 showed excellent safety, tolerability, and pharmacokinetics.
"AFN-1252 shows tremendous promise and fits well with our commitment to bring the best new medicines to patients," said Jim Nightingale, Bend Research President.
Dr. Barry Hafkin, Chief Medical Officer of Affinium Pharmaceuticals, said, "Bend's level of science and corporate commitment to produce an oral solid formulation is unsurpassed in my decades of experience working with formulation experts. Bend's contributions have allowed Affinium to achieve our corporate goal of starting the Phase 2 trial in January of this year. We are confident that the Phase 2 trial will confirm the effectiveness of the AFN-1252 SDD oral dosage form in combating staphylococcalinfections."
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