In a tough indication and a space crowded with developers, Eli Lilly and Co.’s phase III study of the monoclonal antibody mirikizumab for treating moderate to severe ulcerative colitis made a mark by meeting its primary endpoint of clinical remission and all key secondary endpoints compared to placebo.
The question of whether Rubius Therapeutics Inc. would disclose data with its cellular therapy, RTX-240, ahead of the American Association for Cancer Research (AACR) meeting next month was answered in a market-satisfying way as the Cambridge, Mass.-based firm rolled out positive findings from the ongoing phase I/II experiment.
Kintor Pharmaceutical Ltd. said its androgen receptor (AR) antagonist, proxalutamide, reduced mortality risk by 92% and shortened median hospital length stay by nine days vs. standard of care, based on a preliminary analysis of phase III data from 590 hospitalized COVID-19 patients in Brazil. The company expects to have final data ready by the end of this month or early April, Chief Financial Officer Lucy Lu told BioWorld. Following the positive results, Kintor is seeking conditional approval in Brazil and will start another trial in critically ill patients in intensive care, she said.
The sad phase III fate of Abbvie Inc.’s rovalpituzumab tesirine, also known as rova T, in advanced small-cell lung cancer (SCLC) has not discouraged other drug developers targeting delta-like ligand 3 (DLL3) – not all of them, anyway.
Data from two Novavax Inc. clinical trials show its COVID-19 vaccine had 100% protection against severe disease, including hospitalization and death, paving the way for an emergency use authorization submission in the U.S. Mild and moderate COVID-19 was dramatically reduced in both studies, according to the data, and some efficacy was confirmed in variant strains.
DUBLIN – Apeiron Biologics AG reported March 12 that APN-01, recombinant angiotensin converting enzyme 2 (ACE2; alunacedase alfa) failed to attain the primary endpoint of lowering all-cause death or the need for invasive mechanical ventilation in hospitalized patients with severe COVID-19.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Atossa, Bergenbio, Boehringer, Harbour, Inhibrx, Novavax, Noxxon, Sanofi, Swedish Orphan, Translate.
RSS
