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.
Sol-Gel doses first patient in Phase III trial of Epsolay
Sol-Gel Technologies has dosed the first patient in a pivotal Phase III clinical trial programme designed to analyse the safety and efficacy of Epsolay (formerly VERED) for the treatment of patients with papulopustular rosacea, also known as subtype II rosacea.
Agios starts Activate trial for pyruvate kinase deficiency
Agios Pharmaceuticals has started the Activate trial, a Phase lll study analysing the efficacy and safety of AG-348 for the treatment of patients with pyruvate kinase (PK) deficiency who do not receive regular blood transfusions.
Teva announces change in ENFORCE Phase III trial of fremanezumab
Teva Pharmaceutical Industries has announced a change in the ENFORCE Phase III clinical development programme of monoclonal antibody fremanezumab in chronic cluster headache.
MorphoSys presents data from Phase II trial of blood cancer drug
MorphoSys has presented clinical data from the Phase II COSMOS trial, which evaluated MOR208 in combination with the cancer drug idelalisib in patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
Avedro starts enrolment in ACP-KXL-308 trial
Avedro has started patient enrolment in the ACP-KXL-308 trial, a pivotal Phase lll clinical study to examine the safety and efficacy of an epithelium-on (epi-on) corneal collagen cross-linking (CXL) procedure to treat patients with progressive keratoconus.
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).
Apexigen and Yale Cancer Center test oncology combination therapy
US-based Apexigen has partnered with Yale Cancer Center to conduct a Phase I/II clinical trial of its APX005M candidate in conjunction with cabiralizumab and Opdivo to treat advanced solid tumours.
Roche reports positive results from CLL11 study of obinutuzumab
Roche has reported positive results from the final analysis of the phase III study CLL11 assessing Gazyva/Gazyvaro (obinutuzumab)-based treatment in previously untreated chronic lymphocytic leukaemia (CLL).
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