Our first focus: Surgery & trauma
Our powerful technology platform produces synthetic biologics (proteins), called Amicidins, engineered specifically for local application to wounds and exposed tissues. Devised to address the rising threat of antibiotic resistance, Amicidins’ dual mode of action combines beneficial physical properties with potent, broad microbicidal activity for enhanced local performance and safety.
Our first two Amicidins target the needs of surgery and trauma: Amicidin-α is both barrier and microbicide (“block & kill”) to protect clean tissues from contamination; Amicidin-β is surfactant and microbicide (“cleanse & kill”) to address contaminated and dirty tissues, including those with biofilms. We currently have four products in development based on Amicidin-α and Amicidin-β; two nearing clinical trials.
A new class of locally applied biologics to prevent and treat life-threatening infections
Major surgical and traumatic wounds occur 1 million times per day worldwide in a variety of healthcare settings.
Our two lead investigational products, Amicidin-α Surgical Gel and Amicidin-β Solution¹, broadly cover all wound classifications of surgery and trauma and are designed for use in operating rooms and other controlled settings. As first-in-class products intended to prevent and treat infection in surgery and trauma, both are expected to become breakthrough biological therapeutics.
In response to requests for additional products designed for special settings, we are also developing Amicidin-α PFC (Prolonged Field Care) for military use, with support from the U.S. Department of Defense, and Amicidin-β/EF (Extended Formulation) for traumatic wounds and emergency cesarean delivery, including in low- and middle-income countries, with support from the Global AMR Innovation Fund (GAMRIF) through CARB-X.¹
Four ground-breaking products in development to fight infection in surgery & trauma
(1) This work has been supported by US Army Medical Research & Materiel Command through the Military Burn Research Program under Award No. W81XWH-15-2-0065 and by the Assistant Secretary of Defense for Health Affairs through the Peer Reviewed Medical Research Program under Award No. W81XWH-16-1-0561. Opinions, interpretations, conclusions and recommendations are those of Amicrobe and are not necessarily endorsed by the Department of Defense. Ongoing support comes from CARB-X and is provided by the Department of Health & Human Services Asst. Secretary for Preparedness & Response (BARDA) and Wellcome Trust through Boston University subaward 4500002454 and the Department of Health and Social Care (U.K.) through subaward 4500003403.
Amicidins in every major surgical procedure and traumatic wound
(and some other places too)
Amicidin-α Surgical Gel
Amicidin-α Surgical Gel™ is designed for direct application by surgeons to exposed tissues. It is intended for clean (Class I) and clean-contaminated (Class II) surgical procedures, which represent 88% of operating room procedures in the United States. Amicidin-α Surgical Gel mimics the dual protective activities of skin: physical barrier (like keratins & collagens) to block and microbicidal activity (like defensins) to kill. High priority clinical targets include mastectomy with reconstruction, open colorectal surgery, and hernia repair.
Preclinical proof-of-concept has been achieved in multiple studies using three animal models. GLP toxicology studies have begun and feedback has been received from the FDA in a pre-IND face-to-face meeting. Phase 1/2a clinical trials are planned.
Amicidin-α Surgical Gel™ is intended to prevent contamination and infection in surgery.
Amicidin-α PFC™ is designed for military use in prolonged field settings. It is intended to be directly applied to wounds in the field to treat contamination and prevent infection for up to 72 hours. It is also designed to be lightweight and compact for inclusion in military packs. Amicidin-α PFC is proposed to be a dry powder formulation that will gel quickly when introduced to moisture, creating a barrier that will kill microbes already present and prevent new microbes from entering the wound.
Amicidin-α PFC™ (Prolonged Field Care) is intended for prolonged field care of injured warfighters
Amicidin-β Solution™ is designed for direct application to contaminated and infected tissues. It is intended primarily for use in contaminated (Class III) and infected/dirty (Class IV) surgical procedures in the operating room and emergency room. Amicidin-β Solution combines surfactant (detergent-like) activity to provide tissue cleansing & debridement with broad, microbicidal activity to kill. High priority clinical targets include surgical treatment of prosthetic joint infections (PJI) and osteosynthesis site infections, as well as open fractures, which have a high rate of infection.
Amicidin-β Solution™ is in late-stage preclinical development; feedback has been received from the FDA in a pre-IND face-to-face meeting. Phase 1/2a clinical trials are planned.
Amicidin-β Solution™ is intended primarily for treatment of life-threatening infections.
Amicidin-β/EF™ is being developed to prevent and treat infections in emergency settings, such as trauma and emergency cesarean delivery, including in low- and middle-income countries. It maintains the surfactant and microbicidal dual mode of action of the Amicidin-β protein, while increasing tissue coverage through specialized formulation. Amicidin-β/EF has demonstrated preclinical proof-of-concept in two animal models. High priority clinical targets include open fracture and emergency cesarean delivery.
Amicidin-β/EF™ (Extended Formulation) is intended for traumatic wounds and emergency settings, including in low- and middle-income countries.
Beyond surgery & trauma...
Our synthetic biologics platform has a host of applications across multiple industries, from breakthrough therapeutics and innovative medical devices, to enhanced consumer health products and cleaner food and water.
Due to inherent physical (materials) properties of Amicidins, wholly different products can be developed by changes in formulation and fabrication. This includes addition of inactive excipients, as well as other active pharmaceutical ingredients, or even cells. As such, a single Amicidin can yield multiple products with diverse applications in distinct markets.