A new analysis of biomarkers, superseding confusing results released in May, appears to have re-ignited enthusiasm for the experimental Alzheimer’s disease (AD) candidate, sumifilam, the lead development candidate at Texas-based Cassava Sciences Inc.

HONG KONG – Interim results of a phase I study CT-P59, an anti-COVID-19 monoclonal antibody being developed by Incheon, South Korea-based Celltrion Inc., have confirmed the candidate’s safety, tolerability and pharmacokinetics in healthy subjects, giving the company confidence to ramp up production of the experimental antiviral.

LONDON – The U.K. government has signed a €1.4 billion (US$1.7 billion) advance purchase agreement with French biotech Valneva SE, for the supply of up to 190 million doses of its attenuated COVID-19 vaccine, VLA-2001.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: 89bio, AB Science, Actinium, Alexion, Alzprotect, Astrazeneca, Biontech, Blade, Boehringer, Caelum, Cassava, Celltrion, Cyxone, Daiichi, Diamedica, Diamyd, Enanta, Frequency, Humanigen, Immunity, Incyte, Inflarx, LB, Lilly, Myovant, Novartis, Pfizer, Pharmabcine, Regeneron.

Results from the first trial testing the oral autotaxin inhibitor ziritaxestat in adults with diffuse cutaneous systemic sclerosis have encouraged its originator, Galapagos NV, to explore next steps for the program, it said on Sept. 11.

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Anavex, Aura, Atara, Bicycle, Biogen, Cancer Prevention, Celltrion, Clene, Galapagos, Genentech, GW, Immunic, Lilly, Lyra, Neurocrine, Novartis, Partner, Prothena, Reveragen, Santhera, Voyager.

A pivotal test of Satsuma Pharmaceuticals Inc.'s dry powder acute migraine candidate, STS-101, found neither of two doses evaluated met the co-primary endpoints, freeing people from pain or their most bothersome symptom two hours post-administration.