Aimmune sees PALISADE topline results in February
Aimmune Therapeutics announced its outlook for the coming year, including its plans to report topline results in February from its pivotal Phase 3 PALISADE trial of AR101 for peanut allergy, following the completion of the 554-subject trial in late 2017. AR101 is Aimmune's investigational biologic oral immunotherapy for desensitization of patients with peanut allergy. Following expected topline results in February, Aimmune will report more detailed data from the PALISADE trial in a late-breaking oral abstract presentation on Sunday, March 4, 2018, at the American Academy of Allergy, Asthma & Immunology-World Allergy Organization Joint Congress in Orlando. Aimmune anticipates milestones in its additional Phase 3 studies of AR101 throughout 2018. The RAMSES trial, taking place in the United States and Canada and designed to illuminate real-world patient and allergist experiences with AR101, exceeded enrollment projections. Aimmune expects data from RAMSES in the second half of 2018. The ARTEMIS trial, a dedicated European study of AR101, is on track to complete enrollment in the first quarter of 2018, and Aimmune expects data from ARTEMIS in early 2019. To support regulatory filings, Aimmune also plans a data readout from the PALISADE follow-on trial, ARC004, in the third quarter of 2018. Aimmune continues to expect to file a Biologics License Application for AR101 with the U.S. FDA at the end of 2018. Soon afterward, the company plans to begin a similar process in Europe, with the intention of filing a Marketing Authorisation Application with the European Medicines Agency in the first half of 2019. Aimmune's 2018 plans also include the initiation of the ARC005 clinical trial of AR101 for peanut allergy in young children ages 6-48 months, and the initiation, with Regeneron and Sanofi, of a Phase 2 clinical trial of AR101 and adjunctive dupilumab. Aimmune also expects to file an investigational new drug application for its egg allergy program in 2018 and continue work toward filing an IND for walnut allergy in 2019. Aimmune ended 2017 in a strong financial position with approximately $182 million in cash, cash equivalents and investments as of December 31, 2017.