Gene Tektronix's new heavy flu drug Baloxavir marboxil's Phase 3 study CAPSTONE-2 reaches its main destination

today, Genentech, a member of the Roche Group, announced that the, a new drug to assess the efficacy of a new drugheavy influenza, reached its main destination in the phase 3 study CAPSTONE-2, which has the effects of high-risk flu complicationsabout Baloxavir marboxil
Baloxavir marboxil was originally developed by
Japan's Shio
nogi and Co) antiviral drug, which inhibits virus replication by suppressing the cap-dependent nucleic acid endenosine in influenza virusesAnti-fludrugs are(the mechanism of action is to prevent the spread of the virus in the body through targeted neuraminidase)Compared to these drugs, baloxavir marboxil targets the earlier stages of the virus replication cycle, and it can be effective against influenza viruses that have become resistant to oseltamivirrelated studies
In phase 3 of CAPSTONE-1, baloxavir marboxil has demonstrated significant clinical benefits inhealth(population)The U.SFDA(recently accepted its application for a new drug (NDA) and granted it priority review eligibility for single-dose oral treatment for people 12 years of age and older with acute, non-complicational influenzaThe FDA is expected to make a decision on December 24 this yearAsthe release of CAPSTONE-2 is a three-stage, multicenter, randomized, double-blind study that assessed the efficacy of single-dose baloxavir marboxil compared to placebo and oseltamivir in people 12 years of age or older with high-risk flu complicationsSubjects were randomly assigned a single dose of 40 mg or 80 mg baloxavir marboxil, a placebo or 75 mg of oseltamivir for 5 days based on their weightthe main endpoint of the study was to assess the efficacy of a single dose of baloxavir marboxil compared to placebo by measuring the time it took to improve flu symptomsImportant secondary endpoints are the time of de-burning, the time to stop the virus from falling off, and the proportion of subjects who tested positive for influenza virus at the time point or the level of the virus in the body, and the incidence of influenza-related complicationsresults showed that baloxavir marboxil was more efficient at improving flu symptoms at major endpoint times than placebosIn terms of important secondary endpoints, baloxavir marboxil also showed higher efficacy than placebo and oseltamivir, including reducing the amount of time the virus continues to release (viral shedding) and reducing viral levels in the bodyBaloxavir marboxil also significantly reduced the incidence of flu-related complicationsin addition, baloxavir marboxil is well tolerated and no safety issues have been identifiedfull results of the study will be announced at theof the upcoming MedicalConference