Date: 2014-10-06
Type of information: Initiation of the trial
phase: 1b
Announcement: initiation of the trial
Company: Nitto Denko (Japan)
Product: undisclosed new RNAi based drug
Action mechanism:
Disease: cirrhosis
Therapeutic area: Hepatic diseases - Liver diseases
Country: USA
Trial details:
Latest
news: * On October 6, 2014, Nitto Denko Corporation announced the initiation of a phase-1b clinical study in the US started on September 2014, to administer a new anti-fibrosis drug in patients for the assessment of safety and efficacy. Nitto has been developing an RNAi based drug for treating fibrosis in the liver and other organs since 2008 in collaboration with Sapporo Medical University and Hokkaido University. In March 2014, a Phase-1 clinical study in healthy volunteers was completed and no remarkable adverse events were observed, even at the highest dose tested. After thorough analysis of the data, the study results were summarized in a Clinical Study Report which concluded that the drug was safe and well tolerated. These results served as the basis of the phase-1b clinical study plan. The clinical study plan has been approved by a central Institutional Review Board (IRB). This allows Nitto to initiate the phase-1b clinical study in subjects with moderate to severe liver fibrosis for the assessment of safety and efficacy of the drug. Following the start of the US study, Nitto will also conduct a clinical study in Japan. The clinical studies in the US have been conducted in collaboration with RRD International (Rockville, MD), a product development company that provides expert-level strategic, regulatory and operational support.
