Clinical updates, including trial initiations, enrollment status and data readouts and publications: AB Science, Affinivax, Biogen, Briacell, Cidara, Crispr, Gilead, Mycovia, Myovant, Onxeo, Pfizer, Trevi, Vir.
Aptinyx Inc. CEO Norbert Riedel said the design is unclear of the pivotal trial due next year with the N-methyl-D-aspartate (NMDA) receptor modulator NYX-783 in post-traumatic stress disorder (PTSD), as fine points must be hashed out with the FDA.
LONDON - The world’s first COVID-19 human challenge trial is due to start in London next year, after the government announced £33.6 million (US$42.5 million) funding for the project. In the initial phase, the aim is to establish the dose of SARS-CoV-2 needed to cause infection and to characterize the immune response to virus. That will lead on to tests of individual COVID-19 vaccines, in which volunteers will be challenged with the effective dose of SARS-CoV-2 one month after inoculation.
CAJICA, Colombia – The Russian vaccine candidate Sputnik V, developed by Moscow’s Gamaleya National Research Institute of Epidemiology and Microbiology to prevent the SARS-CoV-2 virus that causes COVID-19, is undergoing phase III trials in Venezuela under complete secrecy.
New articles highlighting phase III data on the IL-13 inhibitor tralokinumab from Leo Pharma A/S have shown that combining it with topical corticosteroids as needed was effective and well-tolerated in patients with moderate to severe atopic dermatitis.
Cambridge, U.K.-based Bicycle Therapeutics plc’s phase I dosing about a month ago of its first patient with nectin-4-targeting BT-8009 put the company on the road to hoped-for success by pursuing the same mechanism of action as Padcev (enfortumab vedotin-ejfv), the antibody-drug conjugate (ADC) from Astellas Pharma Inc. and Seagen Inc.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Apellis, Aptose, Intrabio, Leo, Merck & Co., Midatech, Sobi, Ultimovacs, Velosbio.
One of 19 children dosed with an experimental gene therapy for Sanfilippo syndrome has died following the treatment, given as part of a phase II/III trial of the medicine run by its developer, Paris-based Lysogene SA. The trial has been on clinical hold since June, but the immediate cause of the death is unknown, the company said.