Dublin, Ireland, 29th March 2017: Afimmune, a privately held biopharmaceutical company, today announced that the United States Food and Drug Administration (FDA) has granted fast track designation to DS102 as an investigational treatment for patients suffering from non-alcoholic steatohepatitis (NASH) with liver fibrosis.
This designation enables Afimmune to have more frequent meetings with the FDA throughout the development and review process of DS102. The product may also ultimately become eligible for priority review which could potentially lead to earlier drug approval and access for patients suffering from this serious condition. There are currently no approved drugs available for the treatment of NASH.
“This fast track designation is an important acknowledgment by the FDA of the potential that DS102 holds for patients suffering from NASH with liver fibrosis. We will continue to work closely with the FDA to bring DS102 to affected patients as quickly as possible.” commented Dr. John Climax, Afimmune’s Chief Executive Officer.
Afimmune successfully completed a first in man study to assess the safety, pharmacokinetics and effect of food on healthy volunteers who were administered oral DS102. The Company is planning to conduct a Phase 2b study in NASH with fibrosis following completion this year of an ongoing exploratory Phase 2a study in adult patients with non-alcoholic fatty liver disease (NAFLD). Afimmune will also shortly commence a proof of concept Phase 2a study in adult patients with chronic obstructive pulmonary disease (COPD).
Afimmune, headquartered in Dublin, Ireland, is a drug discovery and development company working on inflammatory conditions of the human primary organs including the liver and the lung. DS102 (also designated AF102) was spun out by DS Biopharma into Afimmune in 2016.