Curapath is pleased to acknowledge the significant progress achieved by Macro Biologics, Inc., whose IND application for Amicidin‑α Surgical Gel has been accepted by the FDA, enabling the initiation of the Phase 1 clinical trial. This milestone marks a decisive step in the evolution of the Amicidin‑α platform toward clinical validation and represents a shared achievement resulting from a long‑standing technical and strategic collaboration.
Amicidin‑α Surgical Gel is a synthetic biomaterial designed to protect vulnerable tissues in surgical and traumatic wounds and reduce the risk of infection through a dual mechanism of physical barrier and microbicidal activity. The authorized study, “A Phase 1 Study to Assess Safety and Tolerability of Intrawound Application of Amicidin‑α Surgical Gel in Adult Patients,” will evaluate the safety and tolerability of the gel when applied directly to clean (Class I) and clean‑contaminated (Class II) surgical wounds.
A collaboration driving innovation
As a CDMO specializing in polymer‑ and lipid‑based therapies, drug delivery systems, and nanoparticle technologies, Curapath has supported Macro Biologics across multiple stages of the Amicidin‑α program. The collaboration has spanned early process optimization through GMP manufacturing of both the Amicidin‑α active pharmaceutical ingredient and the Amicidin‑α Surgical Gel drug product.
Curapath has also provided advanced analytical services and performed the fill‑finish operations required to produce the clinical material for the Phase 1 study. This joint effort has supported the program from its earliest development stages through GMP manufacturing, facilitating the IND submission and the supply of clinical trial material for the upcoming Phase 1 study, integrating Curapath’s technical expertise with Macro Biologics’ scientific vision.
“The advancement of Amicidin‑α Surgical Gel into its first‑in‑human study is a source of shared pride. At Curapath, our mission is to support visionary companies like Macro Biologics as they transition from development to the clinic,” said Philippe Clavel, CEO of Curapath. “This milestone reflects the strength of our collaboration and the commitment of both teams to biomedical innovation. We look forward to continuing to support the evolution of this technology as it progresses through clinical development.”
About Macro Biologics
Macro Biologics, Inc. designs, patents, and produces advanced biomaterials for safer healthcare, cleaner water and food, and improved packaging solutions. Its flagship Amicidin‑based programs are designed to protect at‑risk patients by safeguarding vulnerable tissues that serve as gateways for infection. The company’s technology platform and product portfolio are supported by a robust intellectual property estate.
About Curapath
Curapath is a contract development and manufacturing organization (CDMO) specializing in polymer‑ and lipid‑based therapies, drug delivery systems, and nanoparticle technologies. The company supports pharmaceutical and biotechnology partners through process development, analytical services, GMP manufacturing, and fill‑finish operations, helping accelerate the path from early development to clinical and commercial supply.
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