ARS Pharma Readies Data In Response To FDA's Rejection For Its EpiPen Alternative For Severe Allergic Reactions

Tuesday, ARS Pharmaceuticals Inc SPRY released topline results from its clinical study comparing repeat doses of neffy (epinephrine nasal spray) to repeat doses of epinephrine intramuscular (IM) injection.

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 randomized, crossover pharmacokinetic (PK) and pharmacodynamic (PD) study enrolled 43 patients.

NAC involves spraying purified antigen directly onto the nasal mucosa – a ‘worst-case’ experimental condition in contrast to real-world nasal conditions such as upper respiratory tract infections or acute allergic rhinitis from natural causes. 

All patients were dosed with epinephrine within 15 minutes of induction of the NAC during the peak effect without allowing time for nasal symptoms to subside. 

A second dose of epinephrine was given to patients 10 minutes after the first dose per FDA labeling of epinephrine products.

Data from the company’s primary analysis of the completed study showed that responses on 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.

The company says that 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.

William Blair upgraded ARS Pharmaceuticals to Outperform from Market Perform on the positive results and increased visibility into resubmission and launch timing.

Price Action: SPRY shares are up 4.88% at $7.52 on the last check Tuesday.

Photo: Darko Stojanovic from Pixabay