Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen’s COVID-19 Vaccine Candidate

First participants dosed in Phase 3 trial (ENSEMBLE) evaluating safety and efficacy of Janssen’s COVID-19 vaccine candidate, JNJ-78436735, also known as Ad26.COV2.S

NEW BRUNSWICK, New Jersey, Sept. 23, 2020 /PRNewswire/ —¬†Johnson & Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19¬†vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. These results have been submitted to medRxiv and are due to be published online imminently. Based on these results and following discussions with the U.S. Food and Drug Administration (FDA), ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine

Read More

Afimmune Initiates Epeleuton Phase IIb TRIAGE Study in Patients With High Triglycerides and Type 2 Diabetes

Data from Phase IIa show potent effect of Epeleuton on Triglyceride and HbA1C levels

Afimmune, a clinical stage drug discovery company focused on the development of biologically active polyunsaturated lipids for the treatment of cardiometabolic diseases, announced today the start of TRIAGE (TRIglyceride And Glucose control with Epeleuton in Metabolic Syndrome Patients), a Phase IIb study of epeleuton in patients with high triglycerides and type 2 diabetes. Epeleuton is a synthetic prodrug of an endogenous downstream metabolite of eicosapentaenoic acid (EPA).

“In a Phase IIa study in patients with non-alcoholic fatty liver disease (NAFLD), epeleuton not only significantly lowered triglycerides and cholesterol but also statistically and clinically significantly reduced HbA1c and fasting glucose,” said Dr. John Climax, CEO of Afimmune. “Beyond this epeleuton was found to be very safe with no treatment related serious adverse events. These data lead us to believe that epeleuton could

Read More