On December 19 Aimmune Therapeutics announced the initiation of its Phase III POSEIDON trial exploring the use of the oral immunotherapy drug, AR-101, to treat peanut allergy in 1–3-year-old children. This move is extremely important for the company, considering that one of its closest competitors in the peanut allergy space, DBV Technologies, began its EPITOPE trial targeting a similar patient population using its epicutaneous immunotherapy patch, Viaskin Peanut, back in July 2017. GlobalData believes that this age group is a crucial target population for new peanut allergy therapeutics and that the product(s) best able to meet the unique needs of these young children and their parents will command an important portion of market share going forward.
DBV, which submitted its biologics license application (BLA) to the FDA for Viaskin Peanut in October 2018, is targeting its product toward patients 4–11 years of age, while Aimmune, which plans to submit its BLA for AR-101 by the end of 2018, is targeting a larger patient population ranging from age 4–17. Data from the Phase III PALISADE trial also suggest that the therapy is safe and effective in patients 18 and older as well. However, successful use in the 1–3 age range may be even more important for future success than the adult population. Firstly, and most obviously, the patient pool in this young age group is growing rapidly throughout the developed world. Secondly, the more malleable immune systems of younger patients may raise the likelihood for successful desensitisation. Across the board, key opinion leaders (KOLs) and community allergists interviewed by GlobalData believed that treating peanut allergy using immunotherapy products was more consistently effective in younger children. The importance of treating peanut allergy as early as possible is further underlined by the recent overhaul to the National Institute of Allergy and Infectious Diseases (NIAID) peanut allergy guidelines, which now recommend that patients with signs of allergic susceptibility begin eating peanut as early as possible (starting at 6 months of age) in order to prevent a potential allergy.
Despite recent setbacks requiring DBV to withdraw its initial BLA submission for Viaskin Peanut, the company explained that the action was not due to clinical concerns from the FDA but was the result of insufficient data on manufacturing procedures and quality controls. DBV believes that this supporting information can be provided quickly and a new BLA submitted without the need for further clinical studies. Assuming that DBV does resubmit its BLA in a timely fashion, it remains unclear whether Viaskin Peanut or AR-101 will better meet the needs of very young children and their parents. Safety will clearly be of paramount importance when treating this patient population. DBV’s Viaskin Peanut, although not as rapidly effective as oral immunotherapy for peanut allergy, has been shown to have a milder safety profile, which may put parents and physicians of small children more at ease.
However, a major drawback to the epicutaneous immunotherapy paradigm is that patients cannot actually know their level of their peanut tolerance until they are administered an oral food challenge. Thus, this therapy may do less to curb parents’ anxiety about accidental exposures than Aimmune’s AR-101 might do. Because oral immunotherapy requires the direct ingestion of progressively larger quantities of peanut protein, the actual desensitization process may be a bit rockier, but grants parents peace of mind that their child can tolerate a given oral dose of peanut. However, some KOLs interviewed by GlobalData worried that oral immunotherapy may be especially difficult to conduct in very young patients because of the required restrictions to physical activity following dosing as well as the difficulty in evaluating whether a patient who is too young to talk is experiencing an allergic response.
GlobalData posits that Aimmune’s newly begun POSEIDON trial and DBV’s ongoing EPITOPE trial exploring the use of peanut immunotherapy in children 1–3 years old will have a powerful effect on shaping the growing peanut allergy market. The company that is best able to effectively cater to the needs of this complex patient population will have a major advantage.