Monday, July 4

Almirall: its new drug against dermatitis proves safe in phase III

Lebrikizumab, a cytokine IL-13 inhibitor, significantly improved disease severity when combined with topical corticosteroids (TCS) in people with moderate to severe atopic dermatitis (AD) in a third pivotal phase III trial (ADhere) announced today by Almirall. At week 16, the study met all primary and key secondary endpoints.

Lebrikizumab is an investigational new monoclonal antibody (mAb) that binds soluble IL-13 with high affinity., has high bioavailability and a long half-life, and blocks IL-13 signaling.1-5 In people with AD, the IL-13 protein -a central pathogenic mediator of the disease- is overexpressed, driving multiple aspects of pathophysiology of DA by promoting inflammation of T helper cells (T-helper) type 2 (Th2) and leading to skin barrier dysfunction, itching, infection and hard and thickened areas of the skin.

The primary endpoints were the Investigator’s Global Assessment (IGA) of “total skin clearance” (0) or “near total skin clearance” with a reduction of at least two points from the baseline value; and at least 75% percent from baseline EASI score 75, both at week 16. Lebrikizumab in combination with TCS also met all major secondary endpoints versus placebo in AD patients, including improvement of the skin and the relief of itchiness, an improvement in the interference of the itch in the sleep and the quality of life of the patient. Primary secondary endpoints were measured using the EASI, the Numerical Rating Scale (NRS) for pruritus, loss of sleep due to pruritus, and the Dermatologic Quality of Life Index (DLQI).

The safety results of the 16-week placebo-controlled ADhere study were consistent with the 16-week period of the two monotherapy studies of the phase III program of lebrikizumab for AD. In patients treated with lebrikizumab, the most common adverse reactions (ARs) were conjunctivitis and headache.

In August 2021, Almirall announced the preliminary results of the ADvocate 1 and ADvocate 2 studies, showing how lebrikizumab as monotherapy met key primary and secondary endpoints, including pruritus, itch interference with sleep, and quality of life at week 16.

The full results of ADhere, along with data from two phase 3 monotherapy trials, ADvocate 1 and ADvocate 2, are expected to be presented at future scientific meetings in 2022. Pending successful completion of monotherapy trials ADvocate 1 and ADvocate 2 ongoing, Almirall and Eli Lilly and Company intend to start filing regulatory applications in the EU, US and other countries next year.

Almirall has the rights to develop and commercialize lebrikizumab for the treatment of dermatological indications, including AD, in Europe. Lilly has the exclusive rights to develop and commercialize lebrikizumab in the United States and the rest of the world with the exception of Europe.

Leave a Reply

Your email address will not be published.