Allergy Therapeutics has today announced that the FDA has cleared the Group’s Investigational New Drug application (IND) for its novel virus-like particle (VLP)-based peanut allergy vaccine candidate

Thia  paves the way for the initiation of the Phase I PROTECT trial which will be run in the United States. 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, earlier than the originally intended data readout of Q4 2023.

The potential of an effective short-course peanut allergy vaccine represents a significant opportunity in the $8 billion worldwide food allergy market

Manuel Llobet, CEO of Allergy Therapeutics, stated: “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.”

In the short interview below, Manuel Llobet & Nick Wykeman, CEO & CFO respectively, provide highlights from the Group’s recent financial results, in the context of the Company’s three pronged strategy, growing the EU business, entering the US market and developing their pipeline