Renta 4 | Almirall (ALM) has reported positive preliminary results from the pivotal Phase 3 trial, ADorable-1, for lebrikizumab. This trial assesses the efficacy and safety of the drug in children aged between 6 months and under 18 years with moderate to severe atopic dermatitis.
The study met its key primary and secondary endpoints at week 16, demonstrating significant skin clearance, a reduction in disease severity, relief from itching and an improvement in quality of life. The safety profile was consistent with that seen in previous studies in adult and adolescent populations. Almirall holds the rights to develop and commercialise lebrikizumab for dermatological indications in Europe.
Assessment: The positive results of the ADorable-1 trial are welcome news, as they reinforce the potential of lebrikizumab as a key treatment for atopic dermatitis in a population of very young patients, where there is a significant unmet medical need. These results strengthen the profile of one of the most important assets in its portfolio, supporting the continuation of the drug’s paediatric development programme, and represent a crucial step towards obtaining approval for this expanded indication in Europe. Success in expanding the lebrikizumab product information to include infants and young children would increase its market potential, currently estimated at around €450 million. We reiterate our Overweight recommendation with a Target Price of €14 per share.
