ALK announced positive topline results from the phase 2 clinical trial (named ?ALLIANCE?) with its once-daily investigational sublingual immunotherapy (?SLIT?) tablet for the treatment of peanut allergy in patients aged 4-65 years. The trial included 150 patients and was a randomised, double-blinded placebo-controlled dose-finding phase 2 clinical trial evaluating safety and efficacy of two different doses of the peanut tablet compared to placebo. Patients were up-dosed followed by maintenance dosing for 24 weeks. After only 24 weeks of maintenance treatment, clear dose-dependent and statistically significant efficacy was demonstrated across multiple efficacy endpoints based either on the Tolerated Dose (TD) or Eliciting Dose (ED) as measured by a double-blind, placebo-controlled exit food challenge with peanut protein: TD300 efficacy endpoint: 49% of patients treated with the highest dose of the peanut tablet tolerated a dose of 300 mg peanut protein vs.

18% in placebo (p<0.001). TD600 efficacy endpoint:31% of patients treated with the highest dose of the peanut tablet tolerated a dose of 600 mg peanut protein vs. 8% of the placebo treated patients (p<0.01).

TD1000 efficacy endpoint: 22% of patients treated with the highest dose of the peanut tablet tolerated a dose of 1.000 mg peanut protein vs. 2% in placebo (p<0.01). ED based efficacy endpointiii:65% of patients treated with the highest dose of the tablet responded to treatment when defining responders as patients with a baseline ED = 30 mg who achieved an ED = 300 mg or a patient with a baseline of ED = 100 mg who achieved an ED = 600 mg of peanut protein during the oral food challenge (24% in placebo, p<0.001).

Efficacy was observed across all age groups. Treatment with the tablet was safe and well-tolerated across all treatment groups, and the level of treatment-related discontinuations was low. No treatment-related anaphylaxis or treatment-related serious adverse events were reported.

The peanut tablet spearheads ALK?s future portfolio in food allergy, which also spans novel concepts in pre-clinical development targeting other pathways and indications.