WARREN, NJ, Dec. 05, 2023 (GLOBE NEWSWIRE) — Acquisitive Therapeutics, Inc. Technologies (NASDAQ: AQST) (the Company or Acquis), a pharmaceutical company developing medicines to make meaningful improvements in patients’ lives through innovative science and delivery, dosed the first patient in its initial Phase 3 pivotal pharmacokinetic (PK) clinical study of Anafilm (epinephrine) sublingual film. It was announced today. Anafilm is the Company’s orally administered epinephrine prodrug product candidate in development for the treatment of severe life-threatening allergic reactions, including anaphylaxis.
A two-part, phase 3, single-center, open-label, randomized study was designed to compare the PK and pharmacodynamics (PD) of single and repeat doses of Anafilm versus single and repeat doses of epinephrine IM injection and epinephrine autoinjectors (EpiPen and Auvi-Q) in healthy subjects. In adult subjects. The primary objective was to compare the PK of epinephrine following a single administration of Anafilm to a single administration of epinephrine IM injection in healthy adult subjects. Secondary objectives included evaluating PK stability after repeat administration and evaluating safety and tolerability following single and repeat administrations of epinephrine IM injection versus epinephrine autoinjectors.
With the dosing of our first patient, we are officially one step closer to achieving our goal of filing our Anafilm New Drug Application with the FDA in 2024,” said Daniel Barber, Chief Executive Officer of Acquistive. Anafilm continues to be the first and only non-invasive, orally delivered epinephrine product candidate to demonstrate clinical results comparable to autoinjectors for the emergency treatment of severe allergic reactions, including anaphylaxis. We focused on continuing to demonstrate PK comparability of anafilm to existing autoinjectors. We are excited to address the significant unmet need for an orally delivered, convenient and effective product candidate.
Part A of the two-part Phase 3 is designed as a three-period, three-treatment, six sequence, comparative PK study and is expected to enroll up to 36 subjects. Part A assessed both the PK performance and stability of Anafilm 12mg with a bracketed comparison of epinephrine autoinjector (EpiPen) and epinephrine manual IM injection. Part B is designed as a four-period, four-treatment, four-series, comparative PK study and is expected to enroll up to 64 subjects, including those who participated in Part A. Part B assesses the PK of a single dose. Anafilm 12mg with bracket comparison of two autoinjectors (EpiPen and Avi-Q) and manual IM injection.
Anafilm is a polymer matrix-based epinephrine prodrug candidate product. The product is about the size of a postage stamp, weighs less than an ounce, and begins to dissolve on contact. No water or swallowing required for administration. The packaging for Anafilm is slimmer and smaller than the average credit card, pocketable, and designed to withstand weather excursions such as rain and/or exposure to sunlight. AQST-109 is a tradename of Anafilm that has been conditionally approved by the FDA. Final approval of the Anafilm proprietary name is conditioned upon FDA approval of the product candidate.
About Acquisitive Therapeutics
Acquistive is a pharmaceutical company developing medicines to bring meaningful improvement in patients’ lives through innovative science and delivery technologies. We are developing orally administered products to deliver complex molecules, providing new alternatives to invasive and inconvenient standard of care treatments. Acquistive has five commercialized products sold by its licensees in the US and worldwide and is the exclusive manufacturer of these licensed products. The company collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies such as PharmFilm and has proven drug development and commercialization capabilities. Acquisitive is developing a late-stage proprietary product pipeline focused on the treatment of diseases of the central nervous system and an earlier-stage pipeline for the treatment of severe allergic reactions, including anaphylaxis. For more information, visit Questive.com And follow us on LinkedIn.
Certain statements in this press release contain 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 statements regarding the progress and timing of our product candidate Anafilm (epinephrine) sublingual film, including, but not limited to, the potential benefits of Anafilm to patients through clinical development and FDA approval, and other statements that are not historical facts. These forward-looking statements are subject to the uncertain impact of the COVID-19 global pandemic on the Company’s business, including site launch, enrollment and timing of its clinical trials and the adequacy of clinical trials; regulatory submissions and regulatory reviews and approval of Anafilm and Libervant, drug substance and other raw material supply chain, manufacturing and distribution; and the continued availability of an adequate workforce and skilled professionals.
These forward-looking statements are based on the Company’s 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 the Company’s development activities, including, but not limited to, any delays or changes in the timing, cost and success of its product development activities and clinical trials for Anafilm and our other product candidates; the risk of the Company’s ability to generate sufficient data in its PK/PD comparability submission for FDA approval of Anafilm; the Company’s ability to address the FDA’s comments on the Company’s key PK study protocol and other concerns identified at the FDA’s end-of-phase 2 meeting for Anafilm, including the risk that the FDA may require additional clinical studies for Anafilm’s approval; the risk of delay or failure to obtain FDA approval of Anafilm; risks related to the Company’s development activities, including any delays or changes in the timing, cost and success of the Company’s product development activities; risk the success of any competing products; the risk inherent in commercializing a new product (including technological risks, financial risks, market risks and implementation risks and regulatory constraints); the risk of the rate and degree of market acceptance of our product candidates and our licensed products in the US and abroad; the risk of having available debt and equity financing and earnings from operations, the Company’s short-term and long-term liquidity and cash needs and other cash needs, the risk of sufficient capital and cash resources in the timing and amounts necessary to fund future clinical development activities for our other product candidates; the size of our product markets and the risk of growth; risks of compliance with all FDA and other governmental and customer requirements for our manufacturing facilities; losses associated with intellectual property rights and infringement claims related to the Company’s products; the risk of unanticipated patent developments; uncertainties related to general economic, political (including acts of war and terrorism), business, industry, regulatory, economic and market conditions and other unusual factors; and other risks and uncertainties affecting the Company described in the Risk Factors section and the Company’s 2022 Annual Report Quarterly Reports on Form 10-K and Current Reports on Form 8-K to the US 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 they are made. All subsequent forward-looking statements attributable to the Company or any person acting on its behalf are qualified in their entirety by this cautionary statement. The Company undertakes no obligation to update any 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 required by applicable law.
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