Alzhu's precise medical approach is a key study on the resurrection of Alzheimer's disease drugs
An experimental Alzheon treatment designed by Alzheon, designed to reduce the deposition of amyloid plaques in the brain, failed to beat placebo in a Phase 3 study, the latest blow to short-labeled drugs in clinical trials.
Alzhein announced Thursday that the drug Variron dinitrogen salt twice daily did not meet the main clinical trial target of 78-week cognitive decline. Nevertheless, the Framingham, Massachusetts-based company notes that measurements of brain volume indicate a slowdown in brain atrophy, suggesting the potential neuroprotective benefits of the drug.
Alzheon also noted that there were nominal statistically significant cognitive benefits and clinically significant functional effects in the pre-specified subgroup (the earliest patients with the disease). This is a genetically defined subgroup of patients, and Arzu hopes to benefit from the drug.
In its early stages of development into ALZ-801, Alzhain drug obtained permission from Quebec's Bellus Health in 2013. The small molecule of this biotechnology, called aspergillus ester, is designed to bind to beta-amyloid. It is hoped that this approach will prevent the aggregation of amyloid plaques in the brain of patients with Alzheimer's. But the results of two phase 3 studies conducted by Canadian companies show that the drug did not result in statistically significant improvements in cognitive function.
Alzheon's analysis of trastuate data found differences in drug blood levels in the study participants. Valve methyllipid content is a prodrug for asymptomatic, which means it is converted into trastuate in the body. Changes to the Beruz drug include methods to improve the absorption of the compound in vivo, with the aim of reducing the variability observed in previous tests. Alzheon's analysis of data from previous trials also found signs of improvement in patients carrying the APOE4 gene, an increase in the risk of developing Alzheimer's disease. Alzheon's Phase 3 test recruited 325 patients with two APOE4 copies.
The FDA approved the new Alzheimer's drug in the past two years, Eisai's Leqembi and Eli Lilly's Kisunla are antibodies, macromolecular drugs administered through infusion. Alzheon hopes its oral medications will provide patients with the advantage of being easier to administer.
The security edge also has potential. Anti-amyloid antibody drugs introduce brain inflammation and bleeding risks called amyloid-associated imaging abnormalities (ARIA). APOE4 carriers have much higher risk of developing aroma, so patients with Alzheimer's who carry this genetic variant can benefit from offering different approaches. While Leqembi and Kisunla can be used to treat such patients under their FDA approval, the labels of these products come with black box warnings that mark this higher risk of complications. This risk is also a key point in efforts to ensure regulatory approvals in Europe and Australia.
Alzheon said the third phase of Vallitramiprosate was planned to be published in peer-reviewed publications. Despite the lack of the main objectives of the key test, Alzheim did not abandon the drug. When the company announced the preliminary results of the study, Chief Medical Officer Susan Abushakra said patients with two APOE4s were desperate for other treatment options. ”
“The precise medical approach is to meet the needs of patients with Alzheimer's with the APOE4/4 genotype, and we are committed to this patient population,” she said.
A long-term extended study is continuing to evaluate patients who have completed the ventral valve phase 3 test. The ongoing study in the United States, the United Kingdom and Canada is approving patients for 52 weeks. Last June, privately held Alzheon raised $100 million in Series E financing to support the completion of the critical research and prepare for the potential commercialization of its Alzheimer's drug. The NIH National Institute of Aging grant was also supported by a Phase 3 program.
Photo: Yuichiro Chinoimage, Getty Images
