Aimmune Therapeutics (NASDAQ:AIMT) reported new data from a Phase 3 study of AR101, which delivers a daily dose of peanut protein, as a treatment to reduce the frequency and severity of allergic reactions to peanuts.
The new data was gathered from a follow-on study to Aimmune’s international PALISADE study, where patients underwent a 22-week dose escalation period to reach 300 mg of AR101 per day, which was then continued for six months. During the exit food challenge, nearly 77% of subjects could tolerate a 300 mg challenge dose, while some 50% could tolerate a 1,000 mg challenge dose.
The new data showed that extending daily therapy by an additional 28 weeks improved peanut tolerability, with nearly 80% of patients tolerating a 1,000 mg challenge dose, and some 49% tolerating the highest challenge dose of 2,000 mg.
“These findings demonstrate that AR101 treatment extended into the second year reduces adverse events, increases the ability to tolerate even high levels of exposure to peanut protein over time, and further modulates the immune response to peanut in most patients,” Dr. Daniel Adelman, Aimmune’s CMO, said in a statement.
Aimmune plans to submit a marketing authorization application for AR101 to the European Medicines Agency in mid-2019.
