Aimmune’s AR201 PTSR increase as Phase II trial is completed
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LoA Update: Aimmune Therapeutics’ AR201 advancement chances increase as Phase II egg allergy study is completed

25 Jun 2021

Aimmune Therapeutics' Phase II trial completion shifted AR201's Phase Transition Success Rate (PTSR) by 9 points to 11%, as of 21 June.

LoA Update: Aimmune Therapeutics’ AR201 advancement chances increase as Phase II egg allergy study is completed
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. Credits: New Africa/Shutterstock.com.

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.

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.