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, today announced that new clinical data,
including efficacy outcomes supporting
neffy
(epinephrine nasal spray), will be presented during the 2024
American Academy of Allergy, Asthma and Immunology (AAAAI). The
meeting will be held February 23-26, 2024, in Washington, DC.
One late-breaking presentation reports efficacy outcomes for the
first time with neffy in pediatric patients who
developed anaphylaxis symptoms following oral food challenge. The
efficacy data demonstrated that 100% of patients responded to a
single dose of neffy with a 16-minute median time
to complete resolution of anaphylaxis symptoms.
“I believe the robust and rapid clinical responses observed with
neffy during anaphylaxis due to oral food
challenge demonstrate that neffy is at least as
effective as injection,” says Motohiro Ebisawa, M.D.,
Ph.D., Director of Clinical Research Center for Allergy
and Rheumatology at Sagamihara National Hospital, Past-President of
the World Allergy Organization, and Principal Investigator of the
study. “My allergy colleagues and I are eagerly awaiting regulatory
approval of neffy, so that we can prescribe this
needle-free and easy-to-carry treatment option to our severe
allergy patients – many of whom do not carry, do not administer or
delay use of epinephrine autoinjectors.”
A second presentation details the statistically significant and
clinically meaningful reductions in urticaria symptoms achieved by
neffy across all endpoints in its randomized,
controlled proof-of-concept study.
“Epinephrine is the first-line treatment and only medication for
anaphylaxis that reduces risk of hospitalization and death,” says
Sarina Tanimoto, M.D., Ph.D., Chief Medical
Officer and Co-Founder of ARS Pharma. “The data from these studies
to be presented at AAAAI in anaphylaxis and urticaria patients
demonstrated that neffy worked as well and as fast
as delivering epinephrine by injection, but without the need for a
needle and its accompanying limitations.”
ARS Pharma will share data across six presentations, further
demonstrating the company’s commitment to advancing its scientific
leadership position in the allergy community. Additional
neffy data to be presented include
pharmacokinetic/ pharmacodynamic (PK/PD) effects in pediatric
subjects, improved temperature stability versus injection products,
improvements in patient quality of life, and increased device
carriage, use and time to use rates.
Design of neffy
efficacy study in oral food challenge induced
anaphylaxis
This study (jRCT2031230143) assessed the safety and efficacy of
a single dose of neffy given to pediatric patients
with anaphylaxis symptoms induced by an oral food challenge.
2 mg (30 kg+ body weight) or 1 mg (15-30 kg body weight) doses
of neffy were administered when patients exhibited
gastrointestinal, respiratory or circulatory symptoms that were
grade two or higher on the three-grade scale in the Severity
Classification of Organ Symptoms by the Japanese Society of
Allergology Anaphylaxis Guidelines 2022.1
Results from
neffy efficacy study in oral food
challenge induced anaphylaxis
A total of 15 patients aged 6 to 17 were enrolled; 6 subjects
(15-30 kg body weight) were dosed with 1 mg neffy,
and 9 subjects (30 kg+ body weight) were dosed with 2 mg
neffy.
Treatment guidelines indicate a second dose of epinephrine
should be given if clinical response is not observed within the
first 15 minutes.
- 100% of the patients responded to the single dose
of neffy
- After dosing neffy, the median time to
complete resolution of anaphylaxis symptoms was 16 minutes.
- 1 of 15 patients (6.7%) experienced a biphasic reaction 2 hours
and 45 minutes following complete resolution of symptoms with the
single dose of neffy and required additional
epinephrine treatment. For epinephrine injection products, biphasic
reactions are reported to occur at a frequency of 12.8% in children
with food-induced anaphylaxis (Gupta et al. JACI: In Practice,
2021).
- For epinephrine injection products, two or more doses of
epinephrine are required for 10.8% of oral food challenges treated
with epinephrine (n = 2,436 events) (Patel et al. JACI, 2021).
- Clinical data in this neffy trial is therefore
in line with historical clinical response data for injection
products.
The trial demonstrated safety results similar to the previously
reported safety profile of neffy and approved
epinephrine products with adverse events reported in 7 subjects
dosed with neffy, all of which were mild or
moderate and most of which resolved quickly.
ARS Pharma remains on track to announce topline results from its
repeat dose study of neffy under nasal allergen
challenge conditions in the first quarter of 2024 and re-submit its
NDA mid-first half of 2024 with an expected PDUFA action date and
US launch, if approved, in the mid-second half of 2024.
The neffy presentations at AAAAI are listed
below:
neffy clinical efficacy
studies
Title: neffy, epinephrine nasal spray,
Demonstrates a Positive Efficacy and Safety Profile for the
Treatment of Allergic Reactions in Pediatric Patients at-Risk of
Anaphylaxis: Phase 3 Study ResultsDate & Time:
Saturday, February 24, 2024, 9:45 to 10:45 a.m.
ETSession: Late-Breaking Poster Session
IILocation: Convention Center, Level 2, Hall D
Title: ARS-2, Low-Dose Intranasal Epinephrine,
Improves Urticaria Scores in Patients with Frequent Urticaria
Flares: Phase 2 Study ResultsDate & Time:
Monday, February 26, 2024 12:45 to 2:00 p.m. ETPoster Number:
788Session: Novel Insights into
Urticaria/Angioedema/Atopic Dermatitis
neffy PK/PD and product formulation
studies
Title: Pediatric Doses of neffy (Intranasal
Nasal Spray) Demonstrate Pharmacokinetic Profiles That Are
Equivalent to Epinephrine Injections ProductsDate &
Time: Friday, February 23, 2024, 3:15 to 4:15 p.m.
ETPoster Number: 033Location: Convention Center,
Level 2, Hall D
Title: Comparative Stability of Three
Epinephrine Products Under Extreme Temperature
ConditionsDate & Time: Saturday, February 24,
2024, 9:45 to 10:45 a.m. ETPoster Number:
L32Location: Convention Center, Level 2, Hall
D
neffy real-world patient burden
studies
Title: Effect of Needle-Free Epinephrine on
Food Allergy Patient and Caregiver Quality of LifeDate
& Time: Saturday, February 24, 2024, 9:45 to 10:45
a.m. ETPoster Number: 240Location: Convention
Center, Level 2, Hall D
Title: A Survey of Allergists, Pediatricians,
and Primary Care Physicians About the Utilization of
EpinephrineDate & Time: Saturday, February 24,
2024, 9:45 to 10:45 a.m. ETPoster Number:
299Location: Convention Center, Level 2, Hall
D
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. 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 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. 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: the import of study/trial results,
including whether a regulatory agency will ultimately determine
that neffy is safe and effective; ARS Pharma’s
plan to announce topline results from its repeat-dose study under
nasal allergen challenge conditions and file its NDA re-submission
to the FDA; the expected PDUFA action date for
neffy; the potential regulatory approval of
neffy and the anticipated US launch of
neffy, if approved, and the timing thereof;
whether allergy physicians will prescribe neffy,
if approved, instead of injectable epinephrine; 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 “await,” “believe,” “demonstrate,”
“plan,” “expect,” “will,” “potential,” “on track to,” 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
successfully complete the repeat-dose study under nasal allergen
challenge conditions within the anticipated timeframe, as a result
of challenges inherent to enrolling, conducting and completing
clinical trials; study limitations, including relatively small
sample size and the absence of a comparator arm; the results of the
repeat-dose study under allergen-induced allergic rhinitis
conditions may not support the approval of neffy;
results from clinical trials may not be indicative of results that
may be observed in the future; it is possible that the FDA may
refuse to accept our planned NDA for neffy or may
conclude after review of our data that our NDA application is
insufficient to obtain regulatory approval for
neffy; the ability to obtain and maintain
regulatory approval for neffy; potential safety
and other complications from neffy; the labelling
for neffy, if approved; ARS Pharma’s ability to
protect its intellectual property position; the scope, progress and
expansion of developing and commercializing neffy;
the size and growth of the market for neffy and
the rate and degree of market acceptance thereof vis-à-vis
intramuscular injectable products; 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 September 30, 2023, filed with the
Securities and Exchange Commission on November 9, 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 Media Contacts:Laura
O’NeillLaura.oneill@finnpartners.com
ARS Pharma Investor Contacts:Justin ChakmaARS
Pharmaceuticalsjustinc@ars-pharma.com
_____________________1 Anaphylaxis symptoms that triggered
dosing of neffy had to be at least moderate in severity per the
guidelines and could include: generalized urticaria/exanthema/wheal
pruritus, swollen face, throat pain, moderate abdominal pain,
recurrent emesis/diarrhea, repetitive cough, chest
tightness/wheezing detectable via auscultation, pale face/mild
hypotension/tachycardia (>15 beats/min),
light-headedness/feeling of “pending doom”/somnolence/headache.
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