Eisai Co. Ltd. and Biogen Inc. presented the full data set for the Clarity Alzheimer’s disease trial of lecanemab at the 2022 Clinical Trials on Alzheimer’s Disease, which was simultaneously published in the New England Journal of Medicine. The data supported the top-line results released in September 2022.
Eisai Co. Ltd. and Biogen Inc. presented the full data set for the Clarity Alzheimer’s disease trial of lecanemab at the 2022 Clinical Trials on Alzheimer’s Disease, which was simultaneously published in the New England Journal of Medicine. The data supported the top-line results released in September 2022.
Beta-site APP-cleaving enzyme 1 (BACE1) inhibitors have a long history of failure in patients with Alzheimer’s disease. Clinical development of verubecestat, elenbecestat, lanabecestat, umibecestat, atabecestat and LY-3202626 were all discontinued. The drugs largely showed that inhibiting BACE1 reduced amyloid beta (AB) in both cerebrospinal fluid and plasma, reduced AB plaques on PET scans and reduced phosphorylated tau. Unfortunately, patients had early cognitive worsening, and there were signs of lowering of brain volume and increases in psychiatric adverse events.
During a presentation at the Alzheimer's Association International Conference 2022, researchers from the Genetic Frontotemporal Dementia (FTD) Initiative consortium presented data from a study following nearly 1,300 patients with FTD caused by a genetic mutation, their presymptomatic family members who have the inherited mutation and unaffected family members to serve as controls. Researchers have used data from the study, which has been enrolling patients for over 10 years, to develop biomarkers that can be used to assess progression of FTD in interventional clinical trials.
Pfizer Inc. reported on Aug. 30, 2021, that its JAK inhibitor, abrocitinib, beat Dupixent (dupilumab, Regeneron Pharmaceuticals Inc./Sanofi SA) in a head-to-head study of patients with moderate to severe atopic dermatitis. In the JADE DARE study, a higher percentage of patients taking abrocitinib had a 4-point improvement in the severity of Peak Pruritus Numerical Rating Scale (PP-NRS4) from baseline to week two compared to Dupixent.
Graybug Vision Inc. reported results from the phase IIb Altissimo study testing GB-102 as a treatment for wet age-related macular degeneration (AMD) that didn't live up to expectations set by the phase I/IIa Adagio study.
During a panel discussion at Biocom California's Global Life Sciences Partnering Conference, business development executives at various pharmaceutical companies advised biotech companies on everything from funding to manufacturing to deal structure.
Debiopharm International SA is more interested in developing drugs than marketing them. Bertrand Ducrey, CEO of Debiopharm, said he envisions the drugs the company is stewarding through development as a "living pipeline" that needs to be refreshed as drugs get to late-stage development. So Debiopharm is shipping global rights to xevinapant (Debio-1143) and its follow-on inhibitor of apoptosis proteins antagonist, Debio-4028, to Merck KGaA, of Darmstadt, Germany.
Gilead Sciences Inc. was looking to get into oncology in a big way. Arcus Biosciences Inc. had a pipeline of cancer drugs it didn't want to break up. While a little unusual, the landmark 10-year pact the companies made last year just made sense, company executives explained during a session at Biocom California's Global Life Science Partnering Conference.
The 2017 FDA approval of Luxturna (voretigene neparvovec-rzyl, Roche Holding AG) spurred a race to create the next gene therapy for the eye. The organ is very amenable to gene therapy given that it's a confined space with post-mitotic cells that has immune privilege and requires substantially smaller amounts of viral vector compared to systemic treatments.
