Aquestive Therapeutics announced positive topline results from its Oral Allergy Syndrome (OAS) challenge study, revealing that Anaphylm (epinephrine) sublingual film achieved rapid resolution of symptoms associated with severe allergic reactions, including anaphylaxis. The study demonstrated symptom relief beginning just 2 minutes after administration, with a pharmacokinetic (PK) profile comparable to that observed without allergen exposure.
Rapid Symptom Resolution
The OAS challenge study assessed the PK and pharmacodynamic (PD) profile of Anaphylm in adults experiencing allergen-induced oral physiological changes. Participants reported consistent allergy symptoms upon allergen exposure, with 25% experiencing swelling of the tongue, lips, cheeks, or throat, and approximately 94% categorized as having moderate to severe symptoms based on a pre-defined oral severity score.
Complete symptom resolution was observed in an average of 12 minutes following Anaphylm administration, a marked improvement compared to the 74 minutes required for resolution during screening. Notably, some patients experienced symptom resolution as early as 2 minutes, with 50% reporting resolved symptoms within 5 minutes. All instances of swelling were completely resolved within 5 minutes of Anaphylm administration.
Consistent Pharmacokinetic Profile
The study successfully met its primary and secondary endpoints, with no significant differences observed in Anaphylm's PK results between subjects with and without allergen exposure. The time to maximum plasma concentration (Tmax) remained at 12 minutes in both groups after a single dose, with a comparable maximum plasma concentration (Cmax). The safety profile of Anaphylm was also favorable, with all adverse events categorized as mild or moderate.
According to Jay Lieberman, MD, a professor of medicine at the University of Tennessee Health Science Center, the speed of symptom relief and the consistent rapid absorption profile of Anaphylm are reassuring. He believes that these data provide strong evidence that Anaphylm could offer a reliable alternative to currently available epinephrine delivery devices.
Regulatory Pathway and Future Plans
Aquestive Therapeutics is preparing to request a pre-New Drug Application (NDA) meeting with the FDA in Q4 2024. The company also plans to conduct a pediatric study in children weighing 30 kg or more in Q4 2024, with the NDA submission anticipated in Q1 2025. Pending regulatory approval, Aquestive intends to launch Anaphylm in Q1 2026.
Daniel Barber, president and chief executive officer of Aquestive, expressed enthusiasm about the positive results, emphasizing Anaphylm's potential as a game-changing treatment option for severe allergic reactions. He highlighted that the results demonstrate Anaphylm maintains its consistent PK and PD profile even when administered during oral allergic conditions, such as swelling.
Anaphylm is a polymer matrix-based epinephrine prodrug product candidate that dissolves on contact, requiring no water or swallowing for administration.
