Peanuts rank among the top foods that spark allergic reactions, prompting schools to ban peanut butter sandwiches and travelers to decline airline snacks. Aimmune Therapeutics aims to help with a drug that makes people less sensitive to peanuts.
On Tuesday, Aimmune (NASDAQ: AIMT) announced that its drug met the main goals of a late-stage study, and the Brisbane, CA-based company is now planning to file for FDA approval this year. If it gets the FDA’s nod, the Aimmune drug could become the first peanut allergy treatment taken by mouth to reach the market. But some outside observers are expressing caution about side effects and the patient-friendliness of the Aimmune drug, which must be taken daily.
Aimmune’s drug could offer more convenience and safety compared to other attempts to develop peanut allergy drugs. Injectable treatments that desensitize patients to peanut allergies have worked in some patients but their side effects have led researchers to abandon the approach, Aimmune says. Though a therapy given as a food extract placed under the tongue has shown safety, it has been only modestly effective, the company adds. Aimmune’s biologic drug, AR-101, aims to expose patients to controlled doses of peanut protein. The company developed a proprietary mix of the protein and pharmaceutical-grade ingredients that comes in a capsule or a packet that can be opened and mixed with food. The company says increasing the dose over time gradually makes the patient less likely to develop severe allergic reactions.
Aimmune’s randomized, placebo-controlled Phase 3 study enrolled 499 children between the ages of 4 and 17 who have peanut allergies. The study also included 55 adults between the ages of 18 and 49. After one year, 67.2 percent of the children who received the Aimmune drug were able to tolerate at least 600 mg of peanut protein—equivalent to about two peanuts—without experiencing anything more than mild allergy symptoms, the company said. By comparison, just 4 percent of those given a placebo were able to meet that study goal. Those results were similar to the findings of an earlier Phase 2 study.
In the latest study, Aimmune reported that 10 children—nine in the treatment group and one in the placebo group—experienced side effects. Side effects in four of the patients in the treatment group were severe. One experienced anaphylaxis and the other wheezing on the first day of treatment. Both patients dropped from the study. The two other patients had side effects not related to the drug (one patient had a concussion, the other asthma). The side effects in the remaining five patients in the treatment group were mild or moderate, according to the company. Nonetheless, other patients experienced enough discomfort to stop. Aimmune said that in the treatment group, 12.4 percent of patients withdrew from the study, including 6.7 percent who cited stomach problems, and 2.7 percent due to allergic hypersensitivity reactions.
Of the 41 adults in the study who received the Aimmune drug, the company said that 21 stopped, eight of them due to adverse events. Aimmune says that its initial analysis of this age group shows that 85 percent of the adults who completed the study were able to meet the study goals, compared to just 15 percent of those who received a placebo.
The need to take daily doses of the Aimmune drug to build and maintain peanut tolerance and has some observers concerned. In a research note, Leerink Partners analyst Dae Gon Ha wrote that patients could have problems sticking to the drug regimen, pointing out that more than 20 percent of patients withdrew from the Aimmune study. Ha also said that the side effects could be a problem for risk-averse patients. Those patients might prefer a safer, more patient-friendly option such as Viaskin, the peanut allergy skin patch in late-stage clinical testing by Paris-based DBV Technologies, he wrote.
Aimmune said that it expects to file for FDA approval by the end of 2018. A similar filing is expected in Europe in the first half of next year.