Eli Lilly has unveiled a new analysis of trial data showing that its experimental Alzheimer’s disease drug donanemab ‘consistently’ slowed cognitive and functional decline.

This ranged between 20%-40% across all secondary endpoints, with nominal statistical significance at ‘multiple times’ compared to placebo, according to the findings, from a secondary analysis of data from the Phase II TRAILBLAZER-ALZ trial.

Lilly also said that further prespecified exploratory analyses showed donanemab slowed the accumulation of tau tangles in the brains of treated patients, and that 40% of participants treated with the drug achieved amyloid negativity as early as six months after starting treatment, with 68% achieving this target by 18 months.

Donanemab targets a modified form of beta amyloid called N3pG. By targeting N3pG, donanemab has been shown to result in high levels of amyloid clearance, according to Lilly.

The secondary analysis follows previously released top-line data showing significant slowing of decline on the integrated Alzheimer’s Disease Rating Scale (iADRS) in patients with early symptomatic Alzheimer’s compared to placebo (the primary endpoint).

“If these results are confirmed in the larger study now in progress, donanemab could offer the potential for a disease-modifying therapy that can help patients maintain cognitive abilities and their independence longer,” said Howard Fillit, founding executive director and chief science officer of the Alzheimer’s Drug Discovery Foundation, commenting on the findings.

GlaxoSmithKline (GSK) has dosed the first patient in a Phase III trial investigating its long-acting anti-IL-5 monoclonal antibody for the treatment of severe eosinophilic asthma (SEA).

The SWIFT-2 trial is part of a Phase III clinical programme evaluating the safety and efficacy of GSK3511294 (GSK’294), an investigational biologic designed to deliver long-acting suppression of IL-5 in patients with SEA from one injection every six months.
IL-5 is a key cytokine responsible for the proliferation, activation and survival of eosinophils, which plays a role in over 50% of patients with severe asthma, making it a proven target for treatment, according to GSK.

“Around 10% of all asthma patients suffer from the avoidable symptoms of severe eosinophilic asthma and only one in four patients who are eligible for a biologic therapy currently receive one,” said Christopher Corsico, senior vice president development, GSK.

“These patients might benefit from more targeted therapies to better control their condition. We believe GSK’294 could provide another option to these patients that build on the positive impact seen with current anti-IL5 treatments and may also offer the advantage of one subcutaneous injection every six months.”

The Phase III programme for GSK’294 involves three studies and 2,450 patients. SWIFT-1 and SWIFT-2 will assess the therapy in participants with severe uncontrolled asthma with an eosinophilic phenotype, despite standard of care treatment with medium to high dose inhaled corticosteroids as well as one additional controller. NIMBLE will assess whether patients with severe asthma with an eosinophilic phenotype, who are benefiting from mepolizumab or benralizumab treatment, can maintain that benefit when transitioned to GSK’294.