'We are very pleased with the topline results from our repeat dose study of neffy under nasal allergen challenge conditions, which we believe will address
Based on the company's analysis of the data, we believe these results should support filing our response to the
ARS Pharma also completed the nitrosamine testing requested in the CRL per
Previously reported data with a single dose of neffy under NAC conditions showed accelerated absorption of neffy with exposures higher than IM injection during the early time period when clinical response to epinephrine is expected.
'When a severe, life-threatening allergic reaction occurs, it is necessary to administer epinephrine as soon as possible. Based on the single dose NAC data, my allergy colleagues and myself already believed that neffy would be effective under NAC conditions. FDA asked what would happen if NAC conditions occurred during the 10% of anaphylaxis events that require a repeat dose of epinephrine,' says
ARS Pharma intends to submit this repeat dose NAC study data to the FDA as part of its response to the CRL early in the second quarter of 2024.
'The safety and health of severe allergy patients is our shared priority. The neffy repeat dose NAC study should address the theoretical question FDA identified in the small subset of allergy patients who experience rhinitis and may require a second dose of epinephrine,' says
PK/PD Study Results
Data from the company's primary analysis of the completed study showed that responses on pharmacodynamic (PD) surrogate markers for efficacy in anaphylaxis, such as systolic blood pressure and heart rate, correlated well with pharmacokinetic (PK) exposures and were consistently higher for repeat doses of neffy, irrespective of dosing in the same nostril (R/R) or opposite nostrils (R/L), compared to repeat doses of IM injection. Dosing in the same nostril (R/R) resulted in higher PD than injection at all time points measured, while dosing in the opposite nostril (R/L) was higher than injection until the 40 to 60 minute time points, after which PD was indistinguishable from injection.
Consistent with prior studies, significant responses on these PD surrogate markers of efficacy with neffy were observed even at one minute after dosing. The PD responses demonstrate that the epinephrine exposures achieved with repeat doses of neffy (R/R or R/L) fully activate the receptors involved in reversing anaphylaxis symptoms.
The clinical data also demonstrated that mean epinephrine concentrations following repeat doses of 2 mg neffy in the same nostril (R/R) were numerically higher than repeat doses of 0.3 mg injection at all time points through at least 240 minutes under NAC conditions.
Mean epinephrine concentrations of 2 mg neffy in the opposite nostril (R/L) were also numerically higher than repeat doses of 0.3 mg injection for approximately 30 minutes, which is longer than the time period when clinical response would be expected to be observed after dosing epinephrine (i.e., within 10 minutes).
The PK profile of repeat doses of neffy during normal nasal conditions was shown in prior studies to be highly similar to repeat doses of EpiPen, which serves as the upper bracket for exposures established to be safe. In this study, the PK profile of repeat doses of neffy in the same nostril (R/R) during nasal allergen challenge was highly similar to repeat doses of neffy during normal nasal conditions, and therefore also in the range of exposures established to be safe.
Other ARS Pharma clinical studies have evaluated neffy PK/PD in people with the same TNSS and congestion severity scores as the experimental NAC studies, but with nasal symptoms due to real-world conditions such as upper respiratory tract infections or acute allergic rhinitis from natural causes. These other studies showed no meaningful difference on PK/PD compared to dosing neffy under normal nasal conditions.
Repeat doses of neffy were considered safe and well-tolerated. All adverse events were mild and continue to be consistent with those observed in prior studies of neffy across more than 700 subjects. There were no serious adverse events.
Regulatory Status of neffy
Additional discussions with FDA subsequent to its issuance of the CRL confirmed that the new data are anticipated to be informative to labeling of administering a second dose of neffy. In
ARS Pharma intends to file its response to the
About Type I Allergic Reactions including Anaphylaxis
Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in
About
ARS Pharma is a biopharmaceutical company 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 neffy (previously referred to as ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis.
Forward-Looking Statements
Statements in this press release that are not purely historical in nature are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to ARS Pharma's belief that the results of the repeat dosing study will support the filing of the NDA; the timing for the planned NDA filing; the estimated review time of the NDA; the potential approval of neffy; the timing for the potential
Contact:
Email: Laura.oneill@finnpartners.com
Email: justinc@ars-pharma.com
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