Aquestive Therapeutics spotlights epinephrine delivery pipeline at Investor Day

Aquestive Therapeutics hosted a virtual investor day highlighting the Company’s pipeline inclusive of Anaphyl Sublingual Film and AQST-108 Topical Gel, both product candidates emerging from the Company’s Adrenaverse epinephrine prodrug platform. The event included presentations by members of the Aquestive management team and by distinguished key opinion leader J. David Farrar, PhD, Associate Professor, Immunology/Molecular Biology, UT Southwestern Medical Center. “Our pipeline is progressing, and we are excited about the next chapter for growth. We recently submitted our pre-NDA meeting request to the FDA for Anaphylm and are on track to report topline data from our oral allergy challenge study in the coming weeks,” remarked Daniel Barber, CEO. “This is an exciting time for the Company and for our stakeholders, most importantly the patients we seek to help. As our next step for the Adrenaverse platform, we will focus on developing AQST-108 for the treatment Alopecia areata, based on our candidate’s differentiated therapeutic profile and significant unmet need in this indication.” Aquestive outlined that it has completed enrollment in its remaining supportive study for Anaphylm, the oral allergy syndrome challenge study, which is expected to be completed in the fourth quarter of 2024 following the completion of dosing. The Company remains on track to hold the pre-New Drug Application meeting with the U.S. Food and Drug Administration in the fourth quarter of 2024 as it has recently submitted a meeting request letter to the FDA. Aquestive remains focused on completing an NDA submission with the FDA in the first quarter of 2025 and initiating a full product launch of Anaphylm, if approved by the FDA, at the end of 2025 or in the first quarter of 2026. The Company completed its first human clinical study for AQST-108. The two-part study was designed to assess the safety and local tolerability of AQST-108. Part 1 was designed as a single ascending dose escalation study to assess the safety and pharmacokinetics of five different dose levels. The 1.0% dose of AQST-108 was chosen based on the highest dose found with no appreciable transdermal absorption in order to move into the Part 2 study of the development program. In Part 2, three formulations based on excipient variations were evaluated in twelve healthy subjects. In Parts 1 and 2, no serious adverse events or topical adverse events were observed. In Part 2, the calculated percentage of AQST-108 observed in the skin remained consistent across all studied formulations and zero post dose AQST-108 concentrations in plasma were observed. Aquestive unveiled in the event its plan to develop AQST-108 for the treatment of Alopecia areata, which impacts as many as 6.7 million people in United States. AQST-108, a topically delivered adrenergic agonist prodrug, has the potential to support immune privilege in the hair follicle. The Company outlined the design of its planned Phase 2 study to assess the safety and efficacy of AQST-108 in mild to moderate Alopecia areata patients. The Company expects to hold a pre-Investigational New Drug meeting with the FDA in the first quarter of 2025 and to commence the Phase 2 study in the second half of 2025, pending alignment with the FDA.