Amicidin-α and Amicidin-β are synthetic proteins with a lysine-leucine block architecture that combine three qualities into each molecule: (1) broad microbicidal activity (non-antibiotic); (2) optimized physical properties; and (3) safety. Both are purpose-built for direct application to the exposed tissues of surgery and trauma.<br/><br/>Amicidin-α (rel. MW ~35kDa by SEC) at 2wt% in water forms a shear-thinning hydrogel that is easily spread on tissues to form a protective barrier (like collagens and keratins in skin) and brings microbicidal activity to help eliminate contaminating organisms. Amicidin-β (rel. MW ~26kDa by SEC) forms micelles in aqueous media and acts as a biosurfactant for enhanced wound debridement and anti-biofilm properties. Both are manufactured by a robust, four-step process involving ring-opening polymerization of first block, second block, deprotection, and purification. In-process controls and release analytics have been established and GMP manufacturing is underway. Both Amicidins have demonstrated rapid microbicidal activity against gram-positive and gram-negative bacteria, as well as yeast, including multidrug-resistant strains. Both have shown a high level of effectiveness and safety in clinically relevant animal models, including a deep tissue rodent orthopedic model of microbial contamination / infection.<br/><br/>Amicidin-α Surgical Gel and Amicidin-β Solution are investigational products headed toward clinical trials. The clinical development plan (CDP) of the former focuses on intraoperative use to protect against microbial contamination and decrease the risk of surgical site infection in Class I (clean) and Class II (clean-contaminated) surgical procedures. The CDP of the latter focuses on intraoperative and post-operative use to decrease microbial load and treat extant infections, such as periprosthetic joint infection. If successful, these products should help prevent and treat life-threatening infections in the era of antibiotic resistance.

Amicidin-α and amicidin-β: Amino acid block copolymers in development for prevention and treatment of infection in surgery and trauma

2019 Fall National Meeting

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