clinical trials

Dosing has begun in a British Phase 1 trial of a lymphatic filariasis and onchocerciasis drug candidate, AWZ1066S, the Liverpool School of Tropical Medicine (LSTM) announced last week.

Developed through a partnership between Japan’s Eisai, LSTM and the University of Liverpool, the therapy targets symbiotic Wolbachia bacteria in adult worms rather than killing the worms themselves, an approach that may reduce treatment time and accelerate the timeframe of disease elimination “from…

Sanofi is backing out of a collaboration with Sangamo Therapeutics to develop a gene-edited sickle cell disease therapy, California-based Sangamo announced last week.

The news came weeks after Sangamo touted favorable proof-of-concept data on SAR445136 from a Phase 1/2 trial. In the press release, Sanofi’s R&D chief attributed the move to a strategic focus on “universal genomic medicine approaches.” But BioPharma Dive noted that Sangamo’s product is “far behind” a rival gene…

Emergent BioSolutions has dosed the first participant in an Australia-based Phase 1 trial of its nanoparticle-based universal flu vaccine candidate, the Maryland company announced last week.

The study will evaluate the influenza virus A component of EBS-UFV-001. Emergent plans future studies of additional components that would protect against all influenza A and B strains, according to its press release.

Emergent licensed the shot’s self-assembling nanoparticle technology from…

Promising C. difficile drug ridinilazole has failed in Phase 3, CARB-X grantee Summit Therapeutics announced Monday.

The Massachusetts-based company said the study showed that the investigational drug resulted in a higher observed Sustained Clinical Response rate than current standard-of-care vancomycin “but did not meet the study’s primary endpoint for superiority.”

The company did see a “meaningful reduction in recurrence,” however, which Summit Therapeutics linked to the…

Bluebird Bio’s gene therapy for sickle cell disease led to complete resolution of severe vaso-occlusive events and reduced hemolysis in a Phase 1/2 study, the Massachusetts company announced Sunday.

Bluebird presented the data on lovo-cel (formerly LentiGlobin) at the 63rd American Society of Hematology Annual Meeting (ASH) and in the New England Journal of Medicine. The company noted that cases of acute myeloid leukemia in two people treated with the therapy were “unlikely related,”…

Moderna’s mRNA-1010 quadrivalent seasonal influenza vaccine candidate boosted antibody titers against all four strains in both younger and older adults, according to interim Phase 1 data the Massachusetts-based biotech shared last week. The company also revealed that it is developing two “beyond quadrivalent” seasonal flu vaccine candidates—mRNA-1011 and mRNA-1012—that it believes will “expand strain coverage and enhance tools available to public health authorities when selecting antigens,”…

SAB Biotherapeutics’ novel anti-influenza fully human IgG intravenous immunotherapy succeeded in Phase 2a, the South Dakota-based company announced last week.

The SAB-176 polyclonal antibody—for moderate to severe seasonal flu A and B—significantly reduced viral load and clinical symptoms compared to placebo in adults challenged with a pandemic flu strain, the press release said.

A new Phase 1 trial in Mali of Sanaria’s PfSPZ malaria shot showed a three-dose regimen was well-tolerated and conferred 51% vaccine efficacy against intense natural P. falciparum transmission, according to a Lancet Infectious Diseases article published in mid-November.

The results are in line with earlier studies using the five-dose regimen, per the authors.

The Lancet published Phase 3 data on Monday showing that co-administration of ivermectin and albendazole had higher efficacy against T. trichiura than albendazole alone in two of the three regions in the study.

Compared to albendazole monotherapy (the current standard of care), the combination outperformed in Laos (66% vs. 8%) and on Tanzania’s Pemba Island (49% vs. 6%) against the roundworm, but yielded no added benefit in Côte d’Ivoire.

The Swiss Tropical and Public Health…

Merck has halted development of its MK-8507 investigational HIV drug after seeing a decrease in certain white blood cells in Phase 2 participants who took the non-nucleoside reverse transcriptase inhibitor in combination with islatravir, another Merck HIV drug candidate, the company announced in November.

A press release said Merck “remains confident in islatravir’s overall profile” and will continue development of the nucleoside drug. However, out of an “abundance of caution,” Merck…