Aceragen’s wholly-owned subsidiary, Arrevus, awarded $45 million funding agreement from the Department of Defense’s Defense Threat Reduction Agency for Development of ACG-701 as Medical Countermeasure Against Melioidosis
Agreement supports development, manufacturing, and Phase 2 clinical development
Program provides significant value to Aceragen’s overall development of ACG-701 for the treatment of life-threatening orphan infectious diseases
RALEIGH-DURHAM, NC – January 05, 2022 – Arrevus, Inc., a clinical-stage biopharmaceutical company developing therapies for orphan infectious diseases with high unmet medical need, today announced it has been awarded an agreement under which the Defense Threat Reduction Agency (DTRA) has committed up to $45 million in funding to support the development and clinical investigation of Arrevus’ proprietary formulation of sodium fusidate, ACG-701, as a medical countermeasure against Burkholderia pseudomallei, the pathogen that causes melioidosis, for which there are currently no FDA-approved therapies.
“Sodium fusidate has a distinct antimicrobial activity profile with potency that dramatically increases in the low-pH intracellular environment where Burkholderia pseudomallei tends to hide. We believe this novel characteristic, combined with ACG-701’s patented oral formulation that rapidly achieves steady state in circulation, will greatly increase the opportunity for clinical effectiveness against this pathogen,” said Carl Kraus, MD, Chief Medical Officer of Aceragen and the principal investigator of the program.
The DTRA funding will cover manufacturing and supply for clinical execution of a Phase 2 program, and other associated clinical and non-clinical development activities for the treatment and post-exposure prophylaxis (PEP) of melioidosis.
“Sodium fusidate is first line treatment for a number of indications outside the United States, demonstrating broad utility and a remarkable safety profile. Arrevus’ formulation offers the opportunity to treat poorly served or neglected orphan indications, and to meet the US Government’s need for a potent countermeasure against melioidosis,” said Erin Reicher, PhD, Chief of the Vaccines and Therapeutics Division of the Chemical and Biological Technologies Directorate at DTRA.
Arrevus, a wholly-owned subsidiary of Aceragen, Inc., is planning to initiate clinical development in the first half of 2022.
“This is a terrific opportunity to collaborate with DTRA to fill a long-standing gap in the biodefense armamentarium. Leveraging the significant work that has already gone into ACG-701’s development has provided an excellent basis for advancing the program. We are looking forward to 2022 as we start an array of clinical studies for the product, including for melioidosis and cystic fibrosis.” added John Taylor, Chief Executive Officer of Aceragen.
Aceragen is a biopharmaceutical company developing innovative therapeutics for rare and orphan diseases. The Company is advancing ACG-801 (rhAC) as an investigational enzyme replacement therapy for the treatment of patients with Farber disease and potentially other diseases associated with the dysregulation of ceramide metabolism, including cystic fibrosis. Via its Arrevus subsidiary the Company is developing a patented oral formulation of sodium fusidate, ACG-701, as a medical countermeasure for melioidosis in partnership with DTRA, as a treatment for cystic fibrosis-associated pulmonary exacerbations and potentially other severe, orphan infectious diseases.
The Defense Threat Reduction Agency (DTRA), an agency within the United States Department of Defense (DoD), is the official Combat Support Agency for countering weapons of mass destruction (chemical, biological, radiological, nuclear, and high explosives). The Defense Threat Reduction Agency enables DoD, the U.S. Government, and International Partners to counter and deter Weapons of Mass Destruction and Improvised Threat Networks. Under the auspice of the Chemical and Biological Defense Program, DTRA has the responsibility to manage and integrate the DoD chemical and biological defense science and technology programs. DTRA’s continued effort to enhance the combat support mission also advances public health services by developing innovative technologies that protect against biological threats. For more information, visit http://www.dtra.mil/.