ALK-Abelló A/S announced that it has completed the first part of its phase 1 clinical trial for its investigational sublingual immunotherapy tablet for the treatment of peanut allergy. The first part of the trial investigated the safety and tolerability of 14 days treatment with the peanut tablet at different starting doses. For all dose levels, the peanut tablet was shown to be safe and tolerable and with a safety and tolerability profile in accordance with that of the approved SLIT-tablets (ACARIZAX/ODACTRA®?), GRAZAX®?)/GRASTEK®?, RAGWIZAX®?)/RAGWITEK®?), ITULAZAX®?)/ITULATEK®?).

No serious adverse events and no cases of treatment emergent anaphylaxis were reported. Based on results from part 1, the starting dose for the second part of the study has been selected. This part of the study will evaluate the safety and tolerability of up-dosing to the highest tolerable maintenance dose.

The second part will be initiated imminently and is scheduled to complete later in 2024. Furthermore, ALK has decided to amend the ALLIANCE study protocol to include a third part involving approximately 100 additional patients. This part will evaluate safety and efficacy of the peanut SLIT-tablet as assessed by an oral food challenge following a period of maintenance treatment.

The implementation of the third part is contingent upon a successful outcome of the second part. The revised protocol is expected soon to be submitted to the relevant authorities.