Aimmune Therapeutics’ Phase II trial completion shifted AR201’s Phase Transition Success Rate (PTSR) by 9 points to 11%, as of 21 June. Aimmune is a Nestle Health Science company, following its acquisition by the latter in August 2020.
The Phase II trial (NCT04056299), which is evaluating the oral desensitisation therapy regimen AR201 in people with a hen-egg allergy, was completed as per an 18 June update on the trial’s ClinicalTrials.gov entry. The first patient on this study was enrolled in mid-2019, as per a 21 August press release. AR201 is based on the company’s platform Characterised Oral Desensitisation ImmunoTherapy (CODIT) platform which involves desensitising patients with defined amounts of key allergens, thereby providing a meaningful level of protection against allergic reactions. Aimmune has an approval for its peanut allergy immunotherapy Palforzia, based on the same CODIT platform, under its belt.
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The Phase II trial’s primary endpoint is measuring efficacy assessed by the highest tolerated dose of at least 1,000mg dried egg white protein given in a double-blind, placebo-controlled food challenge. While the trial is completed, study results have not yet been posted.
PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next. The PTSR score considers characteristics like therapy area, indication and molecule type, and is used to calculate a drug’s Likelihood of Approval (LoA), which in this case is 8% following a seven-point increase after the trial update.
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