DS Biopharma, headquartered in Dublin, Ireland, and focused on therapies for inflammatory and fibrotic skin and pulmonary disorders, recently announced that a Phase 1 clinical trial evaluating safety and dosing levels for its drug candidate DS102 (15-HEPE) has been successfully completed.
DS102 is an oral bioactive lipid drug developed as a therapy for patients with fatty liver disorders, including non-alcoholic steatohepatitis (NASH), and also pulmonary disorders, including idiopathic pulmonary fibrosis (IPF).
Preclinical studies have shown that DS102 has a therapeutic effect due to its anti-inflammatory and anti-fibrotic properties. In this study, the safety, pharmacokinetics and effect of food on DS102 were assessed in a randomized, double-blind, placebo-controlled, single-ascending and multiple dose trial in 56 healthy volunteers.
Researchers found that treatment for 28 days with single or multiple oral doses of DS102 was safe and well-tolerated, successfully meeting the trial’s primary safety goal. No serious adverse events or treatment discontinuation were reported. The team also found that the presence of food improved the oral absorption of DS102, an observation that should be taken into account in the design of Phase 2 trials.
“The Company welcomes the results of the study which confirmed that DS102 has a very high safety margin in humans. Taken together with positive preclinical results to date, primarily driven by the anti-inflammatory and anti-fibrotic activity of the molecule, the Phase I results pave the way for Phase II studies for DS102 in NASH and other fibrotic conditions such as IPF,” concluded Dr. John Climax, DS Biopharma CEO, in a press release.
NASH is a disorder characterized by fat accumulation in the liver along with inflammation and damage. It occurs in individuals who drink little or no alcohol, and is rapidly becoming a leading cause of cirrhosis and liver failure. IPF is a progressive and fatal lung disease of unknown origin, in which the alveoli and lung tissue become thick and scarred (fibrosis), leading to severe breathing difficulties and compromising oxygen transfer between the lungs and the bloodstream. No cure exists for either NASH or IPF, and both represent unmet medical needs.