Aquestive Therapeutics to Present New Findings on Anaphylm™ (Epinephrine Sublingual Film) at the 2025 AAAAI Annual Meeting
Aquestive Therapeutics (NASDAQ: AQST) has announced new findings on Anaphylm™, their investigational epinephrine sublingual film for treating severe allergic reactions, to be presented at the 2025 AAAAI Annual Meeting in San Diego.
Key findings from the Phase 2 OASIS study (n=36) show that Anaphylm matched or exceeded intramuscular epinephrine in all key pharmacokinetic parameters. The median symptom resolution time was 12 minutes compared to 74 minutes without treatment, with mean angioedema symptom resolution within 5 minutes.
The research demonstrates that Anaphylm maintains stability and potency under extreme conditions, including heat, freezing, and water submersion. The drug's performance was not impacted by oral swelling, and its effectiveness remained consistent regardless of oral allergen challenge conditions.
Aquestive Therapeutics (NASDAQ: AQST) ha annunciato nuove scoperte su Anaphylm™, il loro film sublinguale di epinefrina in fase di sperimentazione per il trattamento di reazioni allergiche gravi, che saranno presentate al 2025 AAAAI Annual Meeting a San Diego.
I risultati chiave dello studio di Fase 2 OASIS (n=36) mostrano che Anaphylm ha eguagliato o superato l'epinefrina intramuscolare in tutti i principali parametri farmacocinetici. Il tempo mediano di risoluzione dei sintomi è stato di 12 minuti rispetto ai 74 minuti senza trattamento, con una risoluzione media dei sintomi di angioedema entro 5 minuti.
La ricerca dimostra che Anaphylm mantiene stabilità e potenza in condizioni estreme, inclusi calore, congelamento e immersione in acqua. Le prestazioni del farmaco non sono state influenzate da gonfiore orale e la sua efficacia è rimasta costante indipendentemente dalle condizioni di sfida con allergeni orali.
Aquestive Therapeutics (NASDAQ: AQST) ha anunciado nuevos hallazgos sobre Anaphylm™, su película sublingual de epinefrina en investigación para el tratamiento de reacciones alérgicas severas, que se presentarán en el 2025 AAAAI Annual Meeting en San Diego.
Los hallazgos clave del estudio de Fase 2 OASIS (n=36) muestran que Anaphylm igualó o superó la epinefrina intramuscular en todos los parámetros farmacocinéticos clave. El tiempo mediano de resolución de síntomas fue de 12 minutos en comparación con 74 minutos sin tratamiento, con una resolución media de síntomas de angioedema dentro de los 5 minutos.
La investigación demuestra que Anaphylm mantiene estabilidad y potencia en condiciones extremas, incluyendo calor, congelación e inmersión en agua. El rendimiento del fármaco no se vio afectado por la hinchazón oral, y su efectividad se mantuvo constante independientemente de las condiciones del desafío con alérgenos orales.
Aquestive Therapeutics (NASDAQ: AQST)는 심각한 알레르기 반응 치료를 위한 연구 중인 서브링구얼 에피네프린 필름인 Anaphylm™에 대한 새로운 발견을 발표했으며, 이는 2025 AAAAI 연례 회의에서 샌디에이고에서 발표될 예정이다.
36명의 참가자가 포함된 2상 OASIS 연구의 주요 결과는 Anaphylm이 모든 주요 약리학적 매개변수에서 근육 주사 에피네프린과 동등하거나 이를 초과함을 보여준다. 증상 해결의 중위 시간이 치료 없이 74분에 비해 12분이었으며, 평균 혈관부종 증상 해결 시간은 5분 이내였다.
이 연구는 Anaphylm이 극한의 조건에서도 안정성과 효능을 유지한다는 것을 보여준다. 즉, 고온, 동결 및 수중 잠금 상태에서도 효과적이다. 약물의 성능은 구강 부종에 영향을 받지 않았으며, 구강 알레르겐 도전 조건에 관계없이 효과는 일관되었다.
Aquestive Therapeutics (NASDAQ: AQST) a annoncé de nouvelles découvertes concernant Anaphylm™, leur film sublingual d'épinéphrine en cours d'investigation pour traiter les réactions allergiques sévères, qui sera présenté lors de la 2025 AAAAI Annual Meeting à San Diego.
Les résultats clés de l'étude de Phase 2 OASIS (n=36) montrent qu'Anaphylm a égalé ou dépassé l'épinéphrine intramusculaire dans tous les principaux paramètres pharmacocinétiques. Le temps médian de résolution des symptômes était de 12 minutes contre 74 minutes sans traitement, avec une résolution moyenne des symptômes d'angioedème en 5 minutes.
La recherche démontre qu'Anaphylm maintient sa stabilité et sa puissance dans des conditions extrêmes, y compris la chaleur, le gel et l'immersion dans l'eau. Les performances du médicament n'ont pas été affectées par un gonflement buccal, et son efficacité est restée constante, quelles que soient les conditions de défi avec des allergènes oraux.
Aquestive Therapeutics (NASDAQ: AQST) hat neue Erkenntnisse zu Anaphylm™, ihrem experimentellen sublingualen Epinephrin-Film zur Behandlung schwerer allergischer Reaktionen, bekannt gegeben, die auf dem 2025 AAAAI Annual Meeting in San Diego präsentiert werden.
Die wichtigsten Ergebnisse der Phase-2-Studie OASIS (n=36) zeigen, dass Anaphylm in allen wichtigen pharmakokinetischen Parametern mit intramuskulärem Epinephrin gleichzog oder es übertraf. Die mediane Zeit zur Symptomauflösung betrug 12 Minuten im Vergleich zu 74 Minuten ohne Behandlung, wobei die durchschnittliche Auflösung der Angioödemsymptome innerhalb von 5 Minuten erfolgte.
Die Forschung zeigt, dass Anaphylm unter extremen Bedingungen wie Hitze, Kälte und Wasseruntertauchen Stabilität und Potenz beibehält. Die Wirksamkeit des Medikaments wurde nicht durch Schwellungen im Mund beeinträchtigt, und seine Effektivität blieb unabhängig von den Bedingungen der oralen Allergenkonfrontation konstant.
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- Data show Anaphylm maintains consistent stability and potency under extreme temperature and real-world conditions, including heat, freezing, and water submersion
- New findings demonstrate dosing of Anaphylm results in consistent epinephrine absorption without impacting safety or pharmacodynamic (PD) parameters
- Anaphylm pharmacokinetic (PK) and PD are not impacted by oral swelling
- Median symptom resolution time was 12 minutes compared to 74 minutes without treatment; mean angioedema symptom resolution time was within 5 minutes.
WARREN, N.J., Feb. 12, 2025 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST) (“Aquestive” or the “Company”), a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies, today announced that multiple presentations highlighting results from the investigational use of Anaphylm epinephrine sublingual film in the treatment of severe allergic reactions, including anaphylaxis, will be featured at the 2025 American Academy of Allergy, Asthma and Immunology (AAAAI) Annual Meeting. The meeting will take place February 28 - March 3, 2025, in San Diego, CA.
“These latest results reinforce the strength of our clinical data and the potential of our product candidate Anaphylm as a reliable, portable, and effective treatment for anaphylaxis,” said Daniel Barber, Chief Executive Officer of Aquestive. “Anaphylm was designed to offer patients a more accessible option for emergency epinephrine administration, without the need for an injection or device, if approved by the FDA. These data further demonstrate Anaphylm’s performance under real-world conditions in resolving angioedema symptoms.”
In the Phase 2 open-label Oral Anaphylm Symptom Intervention Study (“OASIS”) study, adults with Oral Allergy Syndrome (n=36) received Anaphylm under different conditions, including single and repeat dosing with and without oral allergen challenge (OAC), alongside intramuscular (IM) epinephrine injection as a comparator. The study found that:
- Anaphylm matched or exceeded IM epinephrine in all key PK parameters.
- No significant differences in drug performance compared to IM epinephrine were observed, regardless of whether patients had an oral allergen challenge or not.
- Median symptom resolution time was 12 minutes compared to 74 minutes without treatment; mean angioedema symptom resolution time was within 5 minutes.
Additionally, new findings indicate that Anaphylm maintains prior reported top line data in support of stability and potency despite exposure to extreme temperatures and environmental conditions, underscoring its performance in real-world settings where patients may need it most.
Poster presentation details are as follows:
Poster Title: Durability of Anaphylm (Epinephrine Sublingual Film) under Real-World Use
Poster Number: 304
Lead Author: Steve Wargacki, PhD
Presentation Time: Saturday, Mar. 1, 9:45 am – 10:45 am PT
Poster Title: Stability Results of Anaphylm (Epinephrine Sublingual Film) Under Extreme Temperature Conditions
Poster Number: 305
Lead Author: Steve Wargacki, PhD
Presentation Time: Saturday, Mar. 1, 9:45 am – 10:45 am PT
Poster Title: Epinephrine Delivered via Sublingual Film (Anaphylm): Pharmacokinetic and Pharmacodynamic Responses
Poster Number: 312
Lead Author: Carl N. Kraus, MD
Presentation Time: Saturday, Mar. 1, 9:45 am – 10:45 am PT
Poster Title: Oral Anaphylm Symptom Intervention Study (OASIS): Pharmacokinetics, Pharmacodynamics, and Symptom Resolution in Allergy Patients
Poster Number: L18
Lead Author: Carl N. Kraus, MD
Presentation Time: Saturday, Mar. 1, 9:45 am – 10:45 am PT
The abstracts are available online at annualmeeting.aaaai.org, as well as on the Company’s website on the Scientific events page of the of the Investor section.
About Anaphylm™ (epinephrine) Sublingual Film
Anaphylm™ (epinephrine) Sublingual Film is a polymer matrix-based epinephrine prodrug product candidate. Anaphylm is similar in size to a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing is required for administration. The packaging for Anaphylm is thinner and smaller than an average credit card, can be carried in a pocket, and is designed to withstand weather excursions such as exposure to rain and/or sunlight. The Anaphylm trade name for AQST-109 has been conditionally approved by the U.S. Food and Drug Administration (FDA). Final approval of the Anaphylm proprietary name is conditioned on FDA approval of the product candidate.
About Aquestive Therapeutics
Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing novel alternatives to invasive and inconvenient standard of care therapies. Aquestive has five commercialized products marketed by the Company and its licensees in the U.S. and around the world, and is the exclusive manufacturer of these licensed products. The Company also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm®, and has proven drug development and commercialization capabilities. Aquestive is advancing a late-stage proprietary product candidate for the treatment of severe allergic reactions, including anaphylaxis, and an earlier stage epinephrine prodrug topical gel product candidate for possible various dermatology conditions. For more information, visit Aquestive.com and follow us on LinkedIn.
Forward-Looking Statement
Certain statements in this press release include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,” “will,” or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm™ (epinephrine) Sublingual Film through clinical development and approval by the FDA, including filing the NDA for Anaphylm with the FDA and the following launch of Anaphylm, if approved by the FDA; that the results of the Company’s clinical studies for Anaphylm are sufficient to support submission of the NDA for approval of Anaphylm by the FDA; the advancement of the Company’s product candidate AQST-108 through clinical development and approval by the FDA for possible various dermatology conditions; the potential benefits our products and product candidates could bring to patients; and business strategies, market opportunities, and other statements that are not historical facts.
These forward-looking statements are based on our current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to, risks associated with our development work, including any delays or changes to the timing, cost and success of our product development activities and clinical trials and plans, including those relating to Anaphylm (including for pediatric patients) and AQST-108; risk of delays in advancement of the regulatory approval process through the FDA of our product candidates, including the filing of the respective NDAs, including for Anaphylm and AQST-108, or the failure to receive FDA approval at all of any of these product candidates; risk of the Company’s ability to generate sufficient clinical data for approval of our product candidates, including with respect to our pharmacokinetic and pharmacodynamic comparability submission for FDA approval of Anaphylm; risk of the Company’s ability to address the FDA’s comments on the Company’s clinical trials and other concerns identified in the FDA Type C meeting minutes for Anaphylm, including the risk that the FDA may require additional clinical studies for approval of Anaphylm; risk of the success of any competing products; risks and uncertainties inherent in commercializing a new product (including technology risks, financial risks, market risks and implementation risks and regulatory limitations); risk of sufficient capital and cash resources, including sufficient access to available debt and equity financing, including under our ATM facility and the Lincoln Park Purchase Agreement, and revenues from operations, to satisfy all of our short-term and longer-term liquidity and cash requirements and other cash needs, at the times and in the amounts needed, including to fund commercialization activities relating to fund future clinical development and commercial activities for our product candidates, including Anaphylm, should these product candidates be approved by the FDA; risk of eroding market share for Suboxone® and risk as a sunsetting product, which accounts for the substantial part of our current operating revenue; risk of default of our debt instruments; risks related to the outsourcing of certain sales, marketing and other operational and staff functions to third parties; risk of the rate and degree of market acceptance in the U.S. of Anaphylm and our other product candidates, should these product candidates be approved by the FDA, and for our licensed products in the U.S. and abroad; risk of the success of any competing products including generics; risk of the size and growth of our product markets; risk of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; risks associated with intellectual property rights and infringement claims relating to our products; risk that our patent applications for our product candidates, including for Anaphylm, will not be timely issued, or issued at all, by the PTO; risk of unexpected patent developments; risk of legislation and regulatory actions and changes in laws or regulations affecting our business including relating to our products and products candidates and product pricing, reimbursement or access therefor; risk of loss of significant customers; risks related to claims and legal proceedings against Aquestive including patent infringement, securities, business torts, investigative, product safety or efficacy and antitrust litigation matters; risk of product recalls and withdrawals; risks related to any disruptions in our information technology networks and systems, including the impact of cybersecurity attacks; risk of increased cybersecurity attacks and data accessibility disruptions due to remote working arrangements; risk of adverse developments affecting the financial services industry; risks related to inflation and rising interest rates; risks related to the impact of the COVID-19 global pandemic and other pandemic diseases on our business, including with respect to our clinical trials and the site initiation, patient enrollment and timing and adequacy of those clinical trials, regulatory submissions and regulatory reviews and approvals of our product candidates, availability of pharmaceutical ingredients and other raw materials used in our products and product candidates, supply chain, manufacture and distribution of our products and product candidates; risks and uncertainties related to general economic, political (including the Ukraine and Israel wars and other acts of war and terrorism), business, industry, regulatory, financial and market conditions and other unusual items; and other uncertainties affecting us including those described in the "Risk Factors" section and in other sections included in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the U.S. Securities and Exchange Commission. Given those uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are expressly qualified in their entirety by this cautionary statement. The Company assumes no obligation to update forward-looking statements or outlook or guidance after the date of this press release whether as a result of new information, future events or otherwise, except as may be required by applicable law.
PharmFilm® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.
Investor Contact:
Brian Korb
astr partners
brian.korb@astrpartners.com
FAQ
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