Allergy Therapeutics, a UK-based pharmaceutical company specializing in the development of vaccines to combat allergies, announced yesterday that the US Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug application (IND) for its virus-like particle (VLP)-based peanut allergy vaccine candidate.
The FDA’s clearance paves the way for the initiation of the Phase I PROTECT trial which will be run in the United States and start in the first half of 2022. The trial will include multiple cohorts beginning with healthy subjects, followed by peanut-allergic patients who will undergo skin prick tests, and then peanut-allergic patients who will receive subcutaneous injections. The topline data from the Phase I PROTECT trial in adult patients is expected in H1 2023.
Peanut allergy is one of the most common types of food allergy and its symptoms can range from mild to severe and life-threatening. In the western world, the prevalence of peanut allergy doubled between 2005 and 2015 and it is becoming apparent in Africa and Asia. Only about 20% of children diagnosed with peanut allergy outgrow it by the time they reach school age.
Said Manuel Liobet, CEO of Allergy Therapeutics:
We have achieved a key milestone with the FDA’s clearance of our IND application and look forward to advancing our innovative peanut allergy vaccine candidate into the clinic. We are now one step closer to bringing to patients a safe and effective short-course vaccine with the potential to provide long-term protection and a long-lasting protective immune response. I am excited to see the start of the PROTECT trial later this year.
The VLP Peanut candidate is being developed as a VLP-based therapy for the treatment of peanut allergy. This novel immunogenic, protective, and non-reactogenic vaccine candidate is based on immunologically optimized Cucumber Mosaic Virus-derived VLPs (CuMVTT) with the major peanut allergen (Arachis hypogaea) (Ara h2) displayed on its surface. Patents behind the technology to treat peanut allergy with VLP Peanut have been granted in the US and are at the national phase in other territories.