Aceragen Announces Recommendation of Data Monitoring Committee in Terra Study
DURHAM, N.C. and EXTON, Pa., Feb. 06, 2023 (GLOBE NEWSWIRE) -- Aceragen, Inc. (Nasdaq: ACGN) a clinical-stage biopharmaceutical company committed to transforming the care of people living with rare pulmonary and rheumatic diseases, today announced the recommendation of its independent Data Monitoring Committee (DMC) in regard to the on-going TERRA Phase 2 study of ACG-701 in patients with melioidosis. The DMC is responsible for providing oversight of safety and efficacy for this study and has recommended the TERRA study continue without modification.
The DMC review was a planned meeting held in order to monitor the safety of the seriously ill subjects participating in the TERRA study.
“This safety review represents an important milestone for ACG-701, as it allows the TERRA study to continue to evaluate ACG-701 in these hospitalized melioidosis patients. We are very pleased that the DMC recommended that the trial continue. We look forward to delivering the data from the study later this year,” stated Carl Kraus, M.D., Aceragen’s Chief Medical Officer.
ACG-701 for Melioidosis
Aceragen has executed an ~$50 million development partnership with the Department of Defense’s Defense Threat Reduction Agency (“DTRA”) to investigate ACG-701 as a potential medical countermeasure for melioidosis, a life-threatening infection caused by the B. pseudomallei pathogen. This program is centered around a Phase 2 trial, the TERRA study (NCT05105035), which is a randomized double-blind, placebo-controlled trial conducted in hospitalized melioidosis patients. TERRA was initiated in May 2022 and continues to actively enroll patients with a data read-out expected in the fourth quarter of 2023.
About Aceragen, Inc.
Aceragen is a clinical-stage biopharmaceutical company committed to transforming the care of people living with rare pulmonary and rheumatic diseases. Our lead product candidate, ACG-701, is an oral, loading dose formulation of sodium fusidate that is in development for the treatment of melioidosis and acute pulmonary exacerbations associated with cystic fibrosis. ACG-701 has received Fast Track Designation, Orphan Drug Designation, and Qualified Infectious Disease Product (QIDP) from the FDA in acute exacerbations with cystic fibrosis. Aceragen is also developing ACG-801, recombinant human acid ceramidase, as an enzyme replacement therapy for an untreated lysosomal storage disorder called Farber disease. To learn more about us and our programs, please visit Aceragen.com.
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