D3.286 - Rapid Symptom Resolution in Oral Allergy Syndrome Following Anaphylm Administration: A Phase 2 Study Update

Similar to anaphylaxis, Oral Allergy Syndrome (OAS) presents with rapid-onset symptoms following allergen exposure. Understanding the pharmacodynamic response and symptom resolution timeline following Anaphylm administration is critical for assessing its therapeutic potential when considering use in anaphylaxis.

This Phase 2, open-label, 2-part, 3-treatment study compared the pharmacokinetics (PK) and pharmacodynamics (PD) of Anaphylm to intramuscular (IM) epinephrine in adults with OAS. Subjects received single or repeat doses of Anaphylm following oral allergen challenge (OAC). Symptom severity and resolution were assessed using a Verbal Rating Scale (VRS).

Following allergen exposure, 94% (34/36) of subjects exhibited moderate or severe symptoms. Anaphylm administration led to a rapid and significant reduction in symptoms. The median time to full symptom resolution was markedly reduced to 15 minutes and 10 minutes across single and repeat-dose cohorts, respectively, considering the median time of 74 minutes observed at Screening. Notably, by 2 minutes post-administration, 37% and 41% of symptoms were resolved in the single and repeat-dose cohorts, respectively, increasing to 53% and 50% by 5 minutes.

Further analysis by symptom category revealed consistent and accelerated resolution across oral and systemic symptoms. Body system symptoms resolved more rapidly, with 93% and 83% resolution by 2 minutes post-treatment with single and repeat doses, respectively.

These findings demonstrate that Anaphylm facilitates rapid symptom resolution following allergen exposure in OAS, with a median resolution time significantly shorter than previously reported literature estimates (~60 minutes). The study reinforces the utility of OAS as a model for evaluating novel epinephrine formulations and their impact on symptom relief kinetics when considering their use in anaphylaxis.