Immuno-oncology company Imugene Ltd. reported median overall survival for patients receiving HER-Vaxx plus chemotherapy was 13.9 months compared to 8.3 months in patients treated with chemotherapy alone in its phase II study in HER2/neu overexpressing advanced gastric cancer.
Trevi Therapeutics Inc. took its place among several late-stage contenders by scoring a win in prurigo nodularis in the form of positive data from the 360-participant, phase IIb/III Pruritus Relief through Itch-Scratch Modulation, or PRISM, trial with oral Haduvio (nalbuphine extended release).
Clinical data readouts in 2022 have fallen by 14.8% in comparison with the same timeframe last year, and more than half of all reports are for drugs and biologics targeting three major therapeutic areas. In the first six months of the year, there have been 1,707 clinical entries, compared with 2,004 last year.
Italfarmaco SpA will seek meetings with the U.S. FDA and the European Medicines Agency to discuss filing requirements for givinostat in Duchenne muscular dystrophy (DMD) on the strength of data from a phase III trial in which those on the drug exhibited a slower decline in their ability to climb four stairs than those on placebo.
As a growing roster of nations moves to protect individual genomic and other health data in the name of privacy under the General Data Protection Regulation in the EU and similar laws elsewhere, chief aggregators of such data, drug developers, are struggling.
Sanofi SA and GSK plc said new phase III data show their adjuvanted bivalent D614 and beta (B.1.351) COVID-19 vaccine candidate responded well against omicron despite it being designed to fight the original SARS-CoV-2 virus and the beta variant.
Uniqure NV rolled out stock-pleasing safety and biomarker data from 10 patients enrolled in the low-dose cohort of the ongoing phase I/II trial with AMT-130 for the treatment of Huntington’s disease (HD), but investors must wait for details on MRI scans. “We have communicated that we will discuss the MRI findings in the middle of next year,” CEO Matt Kapusta told investors during a conference call. “That’s all I can say.”
Shares of Athira Pharma Inc. (NASDAQ:ATHA) plunged almost 66.3%, or $5.60, to close at $2.85 on June 22 after the company disclosed top-line results from its exploratory phase II study with fosgonimeton (ATH-1017, fosgo) in mild-to-moderate Alzheimer’s disease (AD).
Ionis Pharmaceuticals Inc. and Astrazeneca plc, partners on the antisense oligonucleotide inhibitor eplontersen, said interim phase III data showed the candidate had a positive impact on disease progression in patients with hereditary transthyretin-mediated amyloid polyneuropathy, giving them confidence to plan for a U.S. FDA NDA filing in the indication before the end of 2022.
In this case, more is just too much. The number of participants needed to determine a significant clinical outcome in 9 Meters Biopharma Inc.’s phase III of larazotide in treating celiac disease has grown too large to support the study. The company said an independent statistician’s interim analysis convinced it to take a step back and re-evaluate its options for developing the zonulin inhibitor in the indication.
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