Astrazeneca plc is eyeing an addition to its respiratory diseases portfolio after a potential first-in-class “rescue” asthma inhaler, PT-027, met its goals in two phase III trials.
Chinese companies are finding that their COVID-19 vaccines are effective as booster shots and against variants of the virus, as data from more studies emerge.
PERTH, Australia – Engeneic Ltd. has begun a phase I trial of its nanocellular COVID-19 vaccine, which in preclinical animal studies stimulated a broad antiviral response against mutant strains of the virus, including the virulent Delta strain sweeping across Australia.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adaptimmune, Alnylam, Candel, Horizon, Inversago, Knopp, Lexaria, Newron, Onquality, Pliant, Redhill, Servier, Sobi, Trisalus, United, Valbiotis, Zynerba.
Astellas Pharma Inc. has halted further dosing of the experimental X-linked myotubular myopathy (XLMTM) gene therapy AT-132 (resamirigene bilparvovec) after one participant in the ongoing Aspiro study experienced a serious adverse event (SAE) of abnormal liver function.
Eyegene Inc. has received the green light from South Korea’s Ministry of Food and Drug Safety (MFDS) for EG-COVID, its mRNA COVID-19 vaccine, to enter the clinic. Eyegene will now begin a phase I/IIa trial, to be conducted in two stages, to evaluate the vaccine’s safety, tolerability and immunogenicity.
The phase III fizzle in autism spectrum disorder (ASD) by French firms Les Laboratoires Servier SAS and Neurochlore SAS was the latest in a disease that has proved challenging because of its heterogeneity, which – in the words of Yehezkel Ben-Ari, president of Neurochlore – “probably makes it impossible to offer a sole treatment for all autistic children.”
Shares of Forte Biosciences Inc. (NASDAQ:FBRX) touched a 52-week low, diving 82.3% to close at $5.06 on Sept. 3 after its sole candidate, FB-401, failed to make a statistically significant difference in improving the severity of atopic dermatitis. The result, contrasting starkly with a smaller positive trial, led CEO Paul Wagner to announce the company would quit development of the FDA fast-tracked asset, licensed from the U.S. National Institute of Allergy and Infectious Diseases.
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