On June 12, AstraZeneca and Eli Lilly terminated their two Phase III clinical...
Another BACE inhibitor fails in phase III trials
On June 12, AstraZeneca and Eli Lilly terminated their two Phase III clinical trials of oral amyloid targeting β-secretase (BACE) inhibitor lanabecestat in Alzheimer’s disease (AD). The partners made the decision to terminate AMARANTH (NCT02245737) and the DAYBREAK-ALZ (NCT02783573) trials after an independent data monitoring committee concluded they were unlikely to meet primary endpoints based on interim analysis. The related AMARANTH extension trial (NCT02972658) will also be discontinued. This termination is preceded by recent failures of BACE inhibitors in late stage clinical development for the treatment of AD.
Zepatier for the Treatment of Chronic Hepatitis C GT1 and GT4 Infection
Zepatier is a once-daily, oral selective combination of nonstructural 5A (NS5A) replication complex inhibitor elbasvir (50mg) and non-structural 3/4A protease inhibitor grazoprevir (100mg).
May’s top news stories
Abivax unveiled new data that may suggest its clinical candidate ABX464 could be a safe, functional cure for human immunodeficiency virus (HIV), as well as a method to treat inflammatory diseases; and Cancer Research UK and Experimental Cancer Medicine Centres (ECMC) Network joint venture (JV) Combinations Alliance started the SeluDex trial, a Phase I clinical study to evaluate selumetinib in combination with dexamethasone for treating leukaemia.
Parsabiv™ (etelcalcetide) for the Treatment of Secondary Hyperparathyroidism (SHPT)
Parsabiv™ (etelcalcetide) is an intravenous injectable calcimimetic agent developed by Amgen for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) that were previously treated with haemodialysis.
US biosimilar setbacks highlight difficulty of cost-effective development
Complete response letters (CRLs) were issued by the FDA recently for two biosimilar versions of Roche’s Rituxan—first to Celltrion and Teva on April 9 for Truxima and then to the Sandoz division of Novartis on May 3 for Rixathon, over two months ahead of its Prescription Drug User Fee Act (PDUFA) date, effectively stalling rituximab biosimilar development in the US.
PD-L1 biomarker makes a comeback in bladder cancer
PD-L1 has long been dismissed as a viable biomarker in advanced bladder cancer, given that numerous late-stage clinical trials of PD-1/L1 inhibitors in the disease have reported clinical benefit even in patients who have low or undetectable levels of the biomarker.
POINT trial may increase clopidogrel use in secondary ischemic stroke prevention
Aspirin is still the standard of care (SoC) in the US for patients with non-cardioembolic acute ischemic stroke (AIS) and transient ischemic attack (TIA) to reduce the risk of recurrence. Another antiplatelet drug, clopidogrel, which is sold by Sanofi under the brand name Plavix, is routinely prescribed in combination with aspirin in China.
Phase II most common among immuno-oncology trials, 2008-2017
GlobalData has reviewed the phase of global clinical trials in the immuno-oncology (IO) space that were initiated between 2008 and 2017. For the purposes of this analysis, a small number of Phase 0, Phase I/II, Phase II/III, and Phase III/IV trials were combined with Phase I, Phase II, Phase III, and Phase IV trials, respectively.
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