PLC continues to support the Regulatory filings and the Clinical Trial operations for ARS Pharmaceuticals as they successfully advance the development of ARS-1.
SAN DIEGO–(BUSINESS WIRE)–ARS Pharmaceuticals, Inc., a pharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions potentially leading to anaphylaxis, today announced results from its EPI-04 clinical study evaluating the pharmacokinetics of epinephrine after administration of ARS-1. ARS-1 is an investigational intranasal epinephrine spray that may provide an easy-to-use, convenient and more reliable treatment for severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis. The EPI-04 study is a key step towards completion of the requirements to file an NDA with the US FDA for ARS-1.
The EPI-04 study was designed to measure the pharmacokinetic (PK) profile and pharmacodynamic (PD) response to epinephrine after administration of a 1.0 mg dose of ARS-1 (intranasal epinephrine). Thirty-six (36) subjects with seasonal allergies received up to five treatments in a cross-over design to compare the PK/PD response to epinephrine delivered by ARS-1 or injection. Subjects were randomized to treatment with 1.0 mg ARS-1 intranasal under non-allergy conditions, 1.0 mg ARS-1 intranasal after induction of rhinitis (severe congestion), a 0.3 mg intramuscular (IM) injection, a 0.5 mg IM injection, or a 0.3 mg subcutaneous (SC) injection. All injection products were dosed into the anterolateral thigh area with a needle and syringe – the standard route of administration for epinephrine injection per the U.S. Food and Drug Administration (FDA) label.
This study was designed to evaluate the impact of nasal edema and congestion, which simulate real-world conditions, on the absorption of epinephrine. The results demonstrate that the exposure (AUC0-t) and maximum plasma level (Cmax) of a 1.0 mg ARS-1 dose was comparable to a 0.3 mg IM injection of epinephrine under normal nasal conditions. The time to maximum plasma level (tmax) and time to 100 pg/mL of a 1.0 mg ARS-1 dose was faster than IM injection (time to 100 pg/mL was 9 minutes for ARS-1 and 20 minutes for 0.3 mg IM injection). The time to 100 pg/mL is considered to be where pharmacodynamic responses begin to occur.
After induction of rhinitis the epinephrine Cmax upon administration of 1.0 mg ARS-1 was slightly higher than when subjects were in a normal condition (i.e. absorption was more rapid). The maximum plasma exposure observed with ARS-1 when dosed to subjects with moderate to severe congestion and edema, remained within the range obtained from doses approved in the US and EU product labeling, thus supporting the efficacy and safety of ARS-1 under rhinitis conditions.
“In the EPI-04 study, data indicate that nasal delivery of epinephrine with ARS-1 has a similar pharmacokinetic profile as compared with the intramuscular injection in subjects with and without allergic rhinitis but with a faster time to peak exposure,” said Richard F. Lockey, MD, Professor of Medicine and Pediatrics and the Joy McCann Culverhouse Chair of Allergy and Immunology at the University of South Florida. Dr. Lockey is also a consultant on the ARS Medical Advisory Board. “If approved by the US FDA, results from this study indicate that the use of ARS-1 may be comparable to epinephrine auto-injectors in subjects experiencing a systemic allergic reaction or anaphylaxis. The benefits of this product are that many subjects and caregivers are apprehensive to dose auto-injectors and a product that is potentially easier to use, faster to dose, and causes less apprehension, and as such is an important need in the medical community.”
“The results of the EPI-04 study provide compelling evidence that ARS-1 has the potential to be a safe and effective option for the emergency treatment of life-threatening allergic reactions that addresses many of the current obstacles to use of auto-injectors,” said Richard Lowenthal, President and Chief Executive Officer of ARS Pharmaceuticals. “We believe these data, along with additional studies discussed with the FDA that are still ongoing, will be adequate to support approval of ARS-1 for patients over 25-30 kg weight that require emergency treatment of Type 1 allergic reactions including anaphylaxis. We are also working on our lower dose product for pediatric patients below 25-30 kg in weight that we hope to announce soon. If approved, ARS-1 would be the first-and-only intranasal epinephrine option for patients at risk for these events, providing a safe, low dose, reliable, needle-free treatment option that is easier to carry and use. We look forward to continuing the development of ARS-1 so it is available to the community as soon as possible.”
ARS-1 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) in February 2019. Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need by providing a therapy where none exist or by providing a therapy which may be potentially better than available therapy. Its purpose is to get important new drugs to patients earlier.
ARS-1 is an aqueous formulation of epinephrine nasal spray uniquely developed with Intravail®, a novel nasal absorption enhancing technology. ARS-1 has demonstrated comparable pharmacokinetics to an intramuscular injection of epinephrine in clinical studies using a low and safe intranasal dose (1.0 mg epinephrine administered). As a result, the Company believes that the ARS-1 formulation may enable people to easily deliver epinephrine in emergency situations more rapidly, and with less hesitation, at the onset of an allergic reaction, as compared to currently available epinephrine auto-injectors. The intranasal epinephrine spray is also designed to be user-friendly, needle-free and easily portable to carry in a pocket or purse anytime, anywhere.
Anaphylaxis is a severe, life-threatening allergic reaction with a sudden onset that can occur very quickly — as fast as within a couple of minutes — and could be fatal if not treated immediately. According to published literature up to 5.3 million people in the United States are at risk of having an anaphylaxis reaction that may warrant immediate emergency medical treatment, with more than 200,000 emergency room visits due to severe reactions from food allergies reported annually.
About ARS Pharmaceuticals, Inc.
ARS Pharmaceuticals is dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The Company is developing ARS-1, an intranasal epinephrine spray with a unique absorption technology that could be easy-to-use, needle-free, convenient and more reliable for patients and loved ones at-risk of severe allergic reactions to food, medications and insect bites that could lead to life-threatening anaphylaxis. For more, visit www.ars-pharma.com.
The sprayer is uniquely formulated with Intravail®, an absorption enhancing technology. Intravail® enables the non-invasive delivery of a broad range of protein, peptide and non-peptide drugs (up to 30,000 daltons in size) that can currently only be administered by injection.