A closely watched phase IIb test of JNJ-9220, an investigational HIV vaccine regimen developed by Johnson & Johnson's Janssen Vaccines & Prevention BV, has been stopped because the regimen provided insufficient protection against HIV infection. Though safe, the candidate's efficacy was just 25.2%, according to statisticians who analyzed data from the study, called Imbokodo. Further analysis of the study will continue, and the study was deemed to have provided sufficient data for further immunological correlates research, according to J&J.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Bayer, Bone, Daiichi, Janssen, Kinnov, Lysogene, Nrx, Pfizer, Regeneron, Sanofi, Uniqure.
DUBLIN – AC Immune SA and partner Genentech reported Aug. 31 that their Tau-targeting antibody, semorinemab, brought about a dramatic 43.6% reduction in cognitive decline vs. baseline in a phase II trial in patients with mild to moderate Alzheimer’s disease. The effect was statistically significant (p<0.0025) and is clinically meaningful. Indeed, it represents the biggest single treatment effect ever reported in a clinical trial in this population of Alzheimer’s patients and sets the stage for an extensive phase III program that could set the agenda for Alzheimer’s research for the foreseeable future.
New data from Nrx Pharmaceuticals Inc.’s phase IIb/III trial for treating acute respiratory failure due to critical COVID-19 showed that Zyesami (aviptadil) improved the lung’s ability to transmit oxygen within a day of administration. The respiratory distress ratio’s average difference between those participants receiving aviptadil and placebo was clinically meaningful and statistically significant. The benefit was found across participants, all baseline severities and hospitals of all types.
DUBLIN – Shares in Bone Therapeutics SA dropped by as much as 38% Aug. 30 after the regenerative medicine firm reported that its lead program, JTA-004, flopped in a phase III trial in osteoarthritis of the knee. The candidate therapy, designed to lubricate and protect damaged cartilage in affected joints, failed to meet the primary endpoint of being superior to placebo in reducing pain, as measured on the Western Ontario McMaster Universities Osteoarthritis Index (Womac) pain subscale three months after treatment.
Binhui Biopharmaceutical Co. Ltd.’s BS-001, a recombinant human oncolytic herpes simplex virus type-2 expressing GM-CSF for the potential treatment of solid tumors, has gained an IND approval from the FDA. The development marks the first oncolytic viral candidate developed by a Chinese company to win a go-ahead for trials abroad, it said.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Agenus, Aileron, Airway, Alzecure, Amgen, Ose, Quantum.
Recently published phase II data with Takeda Pharmaceutical Co. Ltd.’s TAK-906 (trazpiroben), a dopamine D2/D3 receptor antagonist, fueled hope for patients as Processa Pharmaceuticals Inc. proceeds with a different – and more focused – approach against gastroparesis.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Amneal, Astrazeneca, Edesa, Everest, Hutchmed, Inmune, Ose, Pardes, Ryvu, Servier, Turn.
Following new positive top-line results from its pivotal phase III study of IPX-203, Amneal Pharmaceuticals Inc. said an NDA submission for the Parkinson’s disease therapy (PD) is now planned for the middle of 2022.
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