What one analyst called “the single most important” nucleoside reverse transcriptase inhibitor in development – Merck & Co. Inc.’s islatravir – has met rocky terrain, with the firm and its partner, Gilead Sciences Inc., pausing combo trials.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aptevo, Dnatrix, Galapagos, Ocuphire, Oncotelic, Oramed, Santhera, Scynexis, Transgene.
Top-line results of Daiichi Sankyo Co. Ltd.’s phase III Quantum-First study, testing the addition of quizartinib to chemotherapy vs. chemotherapy alone for adults with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML), found the combination therapy provided a “statistically significant and clinically meaningful improvement” in overall survival vs. standard treatment alone, meeting the trial’s primary endpoint, Ken Takeshita, global head of R&D at Daiichi Sankyo, told BioWorld.
A phase IIb trial of Connect Biopharma Holdings Ltd.'s CBP-201 in adults with moderate-to-severe atopic dermatitis (AD) showed all three doses tested reduced eczema severity vs. placebo by a statistically significant percentage at 16 weeks, meeting the trial's primary efficacy endpoint.
Mereo Biopharma plc is heading into phase III with a bone-building drug to treat the rare condition osteogenesis imperfecta – and CEO Denise Scots-Knight reckons the company has the financial backing to get setrusumab marketed thanks to a partnership with Ultragenyx Pharmaceutical Inc.