DS Biopharma, a privately held biopharmaceutical company, today announced the successful completion of a Phase I trial with an oral formulation of the active pharmaceutical ingredient DS102 (15-HEPE) which is being explored for the treatment of fatty liver disorders, such as non-alcoholic steatohepatitis (NASH) and pulmonary disorders, such as idiopathic pulmonary fibrosis (IPF).
The Phase I study was a randomised, placebo-controlled, double-blind, single-ascending and multiple dose clinical trial to assess the safety, pharmacokinetics and effect of food on DS102 in 56 healthy volunteers.
The study confirmed that following both single and multiple oral doses over 28 days, DS102 was safe and well tolerated, thereby successfully meeting the study's primary safety objective. There were no serious adverse events or volunteer discontinuations due to adverse events. In addition, it was observed that the presence of food improved the oral absorption of the compound, a result which will help inform the Phase II dosing regimen of this compound.
Commenting on the results, DS Biopharma CEO, Dr. John Climax said:
"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."