New data from an open-label follow-on study, ARC004, from the 52-week PALISADE trial showed a durable treatment effect of Aimmune Therapeutics’ (NASDAQ:AIMT) Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp], the first peanut allergy treatment approved (late
January) in the U.S. The results are being presented at the American
Academy of Allergy, Asthma & Immunology Annual Meeting in
Philadelphia.
Eligible participants completed PALISADE and could
tolerate at least 300 mg (443 mg cumulative) of peanut protein (one
peanut). Treatment duration in ARC004 was either 28 (n=103) or 56 weeks
(n=26).
The ability to tolerate cumulative doses of peanut
protein was sustained or improved after an additional 28 or 56 weeks.
An increased number of patients in both cohorts tolerated peanut protein
doses greater than 300 mg during the ARC004 exit food challenge
compared to the PALISADE exit food challenge. 80% (n=4/5) of patients in
the 56-week group who completed treatment were able to tolerate 2,000
mg (3,443 cumulative) of peanut protein while 49% of the subjects
completing 28 weeks’ treatment could, suggesting progressive
desensitization over time.
On the safety front, the number of
treatment-related adverse events dropped by 59% and 85%, respectively,
in the 28-week and 56-week cohorts with continued dosing beyond one
year. No life-threatening or fatal events were observed.
Management will host a conference call on Monday, March 16, at 12:15 pm ET to discuss the results.
https://seekingalpha.com/news/3551765-aimmunes-palforzia-shows-durable-effect-in-follow-on-peanut-allergy-study
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