ARS Pharmaceuticals, Inc. (Nasdaq: SPRY), a biopharmaceutical
company dedicated to empowering at-risk patients and caregivers to
better protect patients from severe allergic reactions that could
lead to anaphylaxis, announced today the publication of its full
pharmacokinetic and pharmacodynamic results from one of its four
primary registration studies of
neffy (epinephrine
nasal spray) in the Journal of Allergy and Clinical Immunology
(JACI). JACI is the official scientific publication of the American
Academy of Allergy, Asthma and Immunology and the most cited
journal in the field of allergy and clinical immunology. The
clinical study evaluated single and repeat doses of
neffy compared to single and repeat doses of
approved injection products in healthy subjects.
Response on PD surrogates of efficacy
The study showed that neffy elicited comparable or greater
response compared to approved injection products (intramuscular
(IM) injection with needle and syringe, EpiPen), as measured by
pharmacodynamic (PD) profile, the surrogate measure for assessing
clinical effectiveness in anaphylaxis. These responses in PD were
observed even at 1 minute after a single dose of
neffy, with mean maximum changes in heart rate
(Emax) statistically greater than both IM injection and EpiPen and
mean maximum changes in blood pressure (Emax) statistically greater
than IM injection and numerically greater than EpiPen. For repeat
doses of neffy, mean maximum changes in PD
responses for both blood pressure and heart rate were statistically
greater than repeat doses of EpiPen.
“Systolic blood pressure (SBP) and heart rate increases result
from activation of adrenergic receptors that reverse the
anaphylaxis symptoms. Such PD effects occur almost immediately with
neffy, which is highly reassuring from a clinical
perspective,” said Thomas B. Casale, M.D., Professor of Medicine
and Pediatrics and Chief of Clinical and Translational Research in
Allergy/Immunology at the University of South Florida in Tampa, and
lead author of the study. “Repeat dosing of neffy
results in even greater and sustained increases in PD response
compared to EpiPen, which could be clinically important in severe
cases of anaphylaxis that often need a repeat dose of epinephrine,
where patients may experience hypotensive crisis.”
Although the mean PD response for neffy was
higher than EpiPen, the absolute maximum changes in blood pressure
and heart rate for neffy (i.e., outliers) were
comparable to EpiPen and within the range observed during normal
activities such as exercise, ensuring neffy PD
does not exceed the range observed with approved injection products
for safety.
PK profile and safety of
neffy
The study also showed that neffy delivered
consistent epinephrine levels to attain a pharmacokinetic (PK)
profile in the range of approved injection products in healthy
adult subjects. In addition, the PK profile for a second dose of
neffy was approximately dose-proportional, unlike
EpiPen, where the second dose delivered less incremental
epinephrine exposure than the first dose. There was also no
difference in PK profile between twice dosing of
neffy in the same versus different nostrils.
Response on pharmacodynamic (PD) surrogates for efficacy
in anaphylaxis for single and twice dosing
neffy in healthy subjects.
Fig 2 Mean change from baseline in SBP (top), and HR
(bottom) vs time. (A) Single dose. (B) Repeat dose.
neffy was well-tolerated, and all adverse
events were mild. As reported previously, the most common adverse
events in the neffy 2 mg registration program are
mild nasal discomfort (9.7%) and mild headache (6.0%). There is no
meaningful pain or irritation as assessed by formal scales with
mean VAS scores of 5 to 8 on a scale of 100.
“The single and repeat dose neffy study is part
of a rigorous registration program involving more than 600
subjects,” said Dr. Sarina Tanimoto, M.D., Ph.D., Chief Medical
Officer and Co-Founder of ARS Pharma. “We’re pleased and grateful
to share this positive data, and its recognition by the preeminent
allergy journal as JACI’s first epinephrine clinical trial
publication in decades. We believe these results support
neffy’s clinical profile with robust PK/PD
responses that are even greater than injection upon repeat
dosing.”
The article was also highlighted in the “Latest Research”
section of the American Academy of Allergy, Asthma and Immunology
(AAAAI) website, which is the organization that develops treatment
guidelines in the United States for severe allergies.
U.S. regulatory status of
neffyIn May 2023, an FDA Advisory Committee (the
Pulmonary-Allergy Drugs Advisory Committee (PADAC)) concluded a
favorable benefit-risk profile of neffy for
adults and children (≥30 kg) for the treatment of patients with
allergic reactions (Type I), including anaphylaxis. Although no
member of the Committee requested a repeat dose study with
neffy during allergen-induced allergic rhinitis,
and ARS Pharma aligned with FDA in August 2023 that such a study
could be completed as a post-marketing requirement, FDA is now
requiring ARS Pharma to complete this study prior to approval as
outlined in the Complete Response Letter for neffy
sent on September 19, 2023.
FDA stated in its PADAC briefing document that rates of any
nasal mucosal symptoms, including rhinitis, range from 2% to 11% in
anaphylaxis patients, with an average frequency reported in the
literature of 5%. After a single dose with neffy
during allergen-induced allergic rhinitis, the FDA stated that 73%
of patients with moderate to severe symptoms had complete
resolution of nasal symptoms by 30 minutes after dosing, due to
epinephrine’s well-known decongestant effects (Cleveland Clinic
2023, Epinephrine Nasal Spray).
ARS Pharma plans to complete a repeat dose study with
neffy in allergen-induced allergic rhinitis and
file its NDA resubmission to the FDA in the first half of 2024,
with an anticipated launch of neffy, if approved,
in the second half of 2024.
About Type I Allergic Reactions, including
AnaphylaxisType 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 the United States who experience
Type I severe allergic reactions due to food, venom, or insect
stings. Of those, only 3.3 million currently have an active
epinephrine autoinjector prescription, and of those, only half
consistently carry their prescribed autoinjector. Even if patients
or caregivers carry an autoinjector, more than half either delay or
do not administer the device when needed in an emergency.
About ARS Pharmaceuticals, Inc.ARS Pharma is a
biopharmaceutical company dedicated to empowering at-risk patients
and caregivers to better protect patients from severe allergic
reactions that could lead to anaphylaxis. The Company is developing
neffy® (also 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. For
more information, visit www.ars-pharma.com.
Forward-Looking StatementsStatements 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 ability to complete the newly
required trial and provide the additional information requested by
the FDA in the CRL on the timing anticipated, or at all; the
potential approval of neffy; the expected timing for the Committee
for Medicinal Products for Human Use opinion with respect to the
marketing authorization application for neffy; the expected
submissions of neffy to other regulatory authorities in additional
countries and the timing thereof; ARS Pharma’s cash, cash
equivalents and short-term investments on hand upon any future
approval of neffy; and other statements that are not historical
fact. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Words such
as “anticipate,” “plans,” “expects,” “will,” “potential” and
similar expressions are intended to identify forward-looking
statements. These forward-looking statements are based upon ARS
Pharma’s current expectations and involve assumptions that may
never materialize or may prove to be incorrect. Actual results and
the timing of events could differ materially from those anticipated
in such forward-looking statements as a result of various risks and
uncertainties, which include, without limitation, the ability to
obtain and maintain regulatory approval for neffy; the ability to
successful complete the newly requested trial on the timeframe
anticipated at all, as a result of challenges inherent to
enrolling, conducting and completing clinical trials; the results
of the new clinical trial may not support the approval of neffy;
results from clinical trials may not be indicative of results that
may be observed in the future; potential safety and other
complications from neffy; the labelling for neffy, if approved; the
scope, progress and expansion of developing and commercializing
neffy; the size and growth of the market therefor and the rate and
degree of market acceptance thereof vis-à-vis intramuscular
injectable products; ARS Pharma’s ability to protect its
intellectual property position; and the impact of government laws
and regulations. Additional risks and uncertainties that could
cause actual outcomes and results to differ materially from those
contemplated by the forward-looking statements are included under
the caption “Risk Factors” in ARS Pharma’s Quarterly Report on Form
10-Q for the quarter ended June 30, 2023, filed with the Securities
and Exchange Commission on August 10, 2023. This document can also
be accessed on ARS Pharma’s web page at ir.ars-pharma.com by
clicking on the link “Financials & Filings.”
The forward-looking statements included in this press release
are made only as of the date hereof. ARS Pharma assumes no
obligation and does not intend to update these forward-looking
statements, except as required by law.
ARS Pharma Investor Contact:Justin ChakmaARS
Pharmaceuticalsjustinc@ars-pharma.com
ARS Pharma Media Contact:Laura O'NeillFINN
Partnerslaura.oneill@finnpartners.com
Photos accompanying this announcement are available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/04ed043e-0329-45fc-819c-a2bc8cdf6161https://www.globenewswire.com/NewsRoom/AttachmentNg/d49cc156-db1a-4013-b9be-30fce35ab50b
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