— After Two Years of Daily Treatment, More Than
80% of Patients Were Successfully Desensitized to 2000 mg Peanut
Protein or Equivalent of About 14 Peanut Kernels—
— Majority of Patients Treated Daily Also
Reported Lower Rates of Adverse Events and Showed Higher Rates of
Desensitization Compared to Non-Daily Dosing Groups —
Aimmune Therapeutics, Inc. (Nasdaq: AIMT), a biopharmaceutical
company developing and commercializing treatments for potentially
life-threatening food allergies, today announced new two-year data
that suggest long-term efficacy of daily treatment with PALFORZIA™
[Peanut (Arachis hypogaea) Allergen Powder-dnfp] in patients with
peanut allergy. Patients dosed daily in the study also showed
ongoing immunomodulation and higher rates of desensitization that
increased over time compared to those patients who were
administered non-daily dosing. Furthermore, the majority of
patients in the daily dosing groups reported lower adverse event
(AE) rates compared to those in the non-daily dosing groups, with
an overall safety profile of long-term daily dosing with PALFORZIA
that was better than non-daily dosing.
These two-year results from ARC004, a follow-on study to the
pivotal phase 3 PALISADE trial, were presented during the digital
European Academy of Allergy and Clinical Immunology (EAACI)
Congress and are available for on-demand viewing at EAACI
scientific programme website.
“We’re excited that these two-year data provide not only further
insight into the long-term efficacy and safety profile of PALFORZIA
resulting from continued daily treatment, but also show that
patients exhibit the long-term effects of modulating the immune
system,” said Daniel Adelman, M.D., Chief Medical Officer of
Aimmune. “These are important data that reinforce and build on the
findings from our pivotal PALISADE trial. We look forward to
continuing to evaluate these patient groups over time to assess how
daily treatment with PALFORZIA may result in further disease
modification. We are grateful to the patients who continued their
daily treatment to allow us to report these results with a high
study completion rate.”
A greater proportion of patients who continued daily long-term
dosing with PALFORZIA in ARC004 completed the study compared to
those patients in the non-daily treatment groups. Furthermore,
after two years of daily treatment with PALFORZIA, more than 80% of
patients undergoing the food challenge demonstrated desensitization
to 2000 mg peanut protein (4043 mg cumulatively [equivalent to ~14
peanut kernels]). Desensitization rates associated with PALFORZIA
treatment were higher in the daily dosing groups compared to the
non-daily dosing groups; within the daily dosing groups,
desensitization rates improved with duration of therapy.
Changes in immunologic measures showed ongoing immunomodulation
during the first two years of treatment with PALFORZIA with further
modulation of immunologic and improvement in clinical parameters in
subsequent years anticipated to occur.
Patients in the two daily dosing groups also reported fewer
treatment-related adverse events (TRAE) when adjusted for the
number of patient-years of exposure compared to the three non-daily
dosing groups. Adverse events in the daily dosing groups were
mostly mild to moderate with only three patients reporting severe
events observed in over 100 patient-years of exposure. The overall
rate of AE-related discontinuations was low but slightly higher in
the longer-term non-daily dosing groups. Across treatment groups,
PALFORZIA appeared to be well tolerated and was consistent with
previous studies with no new safety concerns.
“The findings from ARC004 suggest that long-term daily dosing
with PALFORZIA lead to higher rates of desensitization and ongoing
immunomodulation, underscoring that for at least the first two
years of treatment, daily dosing during maintenance is the optimal
approach for this patient population,” continued Dr. Adelman.
PALFORZIA was approved by the U.S. Food and Drug Administration
(FDA) in January 2020 as an oral immunotherapy for the mitigation
of allergic reactions, including anaphylaxis, that may occur with
accidental exposure to peanut in patients aged 4 through 17 years
with a confirmed diagnosis of peanut allergy. In Europe, Aimmune’s
marketing authorization application for AR101 is under review with
the European Medicines Agency (EMA). A Swiss Agency for Therapeutic
Products (SwissMedic) review of AR101 also is ongoing.
About ARC004
ARC004 was an open-label follow-on study to the phase 3 PALISADE
trial and assessed the safety and efficacy of extended daily and
non-daily dosing of PALFORZIA across 351 peanut-allergic patients
aged 4-17 years. Participants who received placebo (AR101-naïve) in
PALISADE received active treatment with AR101, and eligible
participants who received AR101 in PALISADE (AR101 continued) were
assigned to either daily or non-daily continued treatment regimen
with different durations. A total of 261 AR101-treated participants
completed the ACR004 study.
INDICATION
PALFORZIA is an oral immunotherapy indicated for the mitigation
of allergic reactions, including anaphylaxis, that may occur with
accidental exposure to peanut. PALFORZIA is approved for use in
patients with a confirmed diagnosis of peanut allergy. Initial Dose
Escalation may be administered to patients aged 4 through 17 years.
Up-Dosing and Maintenance may be continued in patients 4 years of
age and older.
PALFORZIA is to be used in conjunction with a peanut-avoidant
diet.
Limitations of Use: Not indicated for the emergency treatment of
allergic reactions, including anaphylaxis.
IMPORTANT SAFETY INFORMATION
Boxed WARNING:
PALFORZIA can cause anaphylaxis, which may be life
threatening and can occur at any time during PALFORZIA
therapy.
Prescribe injectable epinephrine, instruct and train patients
on its appropriate use, and instruct patients to seek immediate
medical care upon its use.
Do not administer PALFORZIA to patients with uncontrolled
asthma.
Dose modifications may be necessary following an anaphylactic
reaction.
Observe patients during and after administration of the
Initial Dose Escalation and the first dose of each Up-Dosing level,
for at least 60 minutes.
PALFORZIA is available only through a restricted program
called the PALFORZIA REMS.
CONTRAINDICATIONS
PALFORZIA is contraindicated in patients with uncontrolled
asthma, or with a history of eosinophilic esophagitis and other
eosinophilic gastrointestinal disease.
WARNINGS AND PRECAUTIONS
Anaphylaxis
PALFORZIA can cause anaphylaxis, which may be life threatening.
PALFORZIA is available only through a restricted program under a
Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA
REMS because of the risk of anaphylaxis. Only prescribers,
healthcare settings, pharmacies, and patients certified and
enrolled in the REMS Program can prescribe, receive, dispense or
administer PALFORZIA.
Anaphylaxis has been reported during all phases of PALFORZIA
dosing, including Maintenance and in subjects who have undergone
recommended Up-Dosing and dose modification procedures.
Do not initiate PALFORZIA treatment in a patient who has had
severe or life-threatening anaphylaxis within the previous 60 days.
PALFORZIA may not be suitable for patients with certain medical
conditions that may reduce the ability to survive anaphylaxis,
including but not limited to markedly compromised lung function,
severe mast cell disorder, or cardiovascular disease. In addition,
PALFORZIA may not be suitable for patients taking medications that
can inhibit or potentiate the effects of epinephrine.
All Initial Dose Escalation doses and the first dose of each
Up-Dosing level must be administered in a certified health care
setting.
Patients may be more likely to experience allergic reactions
following PALFORZIA administration in the presence of cofactors
such as exercise, hot water exposure, intercurrent illness (e.g.,
viral infection), or fasting. Other potential cofactors may include
menstruation, sleep deprivation, nonsteroidal anti-inflammatory
drug use, or uncontrolled asthma. Patients should be proactively
counseled about the potential for the increased risk of anaphylaxis
in the presence of these cofactors. If possible, adjust the time of
dosing to avoid these cofactors. If it is not possible to avoid
these cofactors, consider withholding PALFORZIA temporarily.
Asthma
Uncontrolled asthma is a risk factor for a serious outcome,
including death, in anaphylaxis. Ensure patients with asthma have
their asthma under control prior to initiation of PALFORZIA.
PALFORZIA should be temporarily withheld if the patient is
experiencing an acute asthma exacerbation. Following resolution of
the exacerbation, resumption of PALFORZIA should be undertaken
cautiously. Re-evaluate patients who have recurrent asthma
exacerbations and consider discontinuation of PALFORZIA.
Eosinophilic Gastrointestinal Disease
Discontinue PALFORZIA and consider a diagnosis of eosinophilic
esophagitis in patients who experience severe or persistent
gastrointestinal symptoms, including dysphagia, vomiting, nausea,
gastroesophageal reflux, chest pain, or abdominal pain.
Gastrointestinal Adverse Reactions
Gastrointestinal adverse reactions were commonly reported in
PALFORZIA-treated subjects, and dose modification should be
considered for patients who report these reactions. For severe or
persistent gastrointestinal symptoms consider a diagnosis of
eosinophilic esophagitis.
ADVERSE REACTIONS
The most common adverse events reported in subjects treated with
PALFORZIA (incidence ≥ 5% and ≥ 5% than placebo) are abdominal
pain, vomiting, nausea, oral pruritus, oral paresthesia, throat
irritation, cough, rhinorrhea, sneezing, throat tightness,
wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and
ear pruritus.
Please see full Prescribing Information, including Boxed
WARNING, and Medication Guide at www.PALFORZIA.com.
For more information about PALFORZIA, please call 1-844-PALFORZ
(1-844-725-3679) or visit www.PALFORZIA.com.
About Aimmune
Aimmune Therapeutics, Inc. is a biopharmaceutical company
developing and commercializing treatments for potentially
life-threatening food allergies. With a mission to improve the
lives of people with food allergies, Aimmune is developing and
commercializing oral treatments for potentially life-threatening
food allergies. The Company’s Characterized Oral Desensitization
ImmunoTherapy (CODIT™) approach is intended to provide meaningful
levels of protection against allergic reactions resulting from
accidental exposure to food allergens by desensitizing patients
with defined, precise amounts of key allergens. Aimmune has one
FDA-approved medicine for peanut allergy and other investigational
therapies in development to treat other food allergies. For more
information, please visit www.aimmune.com.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are “forward-looking statements”
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements regarding:
Aimmune’s expectations regarding its evaluation of the potential
benefits of daily treatment with PALFORZIA, including benefits
related to changes in immunologic measures;; and Aimmune’s
expectations regarding potential applications of the CODIT approach
to treating life-threatening food allergies. Risks and
uncertainties that contribute to the uncertain nature of the
forward-looking statements include: the risk that the COVID-19
worldwide pandemic may continue to negatively impact the business,
research and clinical operations of Aimmune or its partners;
Aimmune’s or any of its collaborative partners’ ability to initiate
and/or complete clinical trials; the unpredictability of the
regulatory process; the possibility that Aimmune’s or any of its
collaborative partners’ clinical trials will not be successful;
Aimmune’s dependence on the success of PALFORZIA; Aimmune’s
reliance on third parties for the manufacture of Aimmune’s products
and product candidates; possible regulatory developments in the
United States and foreign countries; and Aimmune’s ability to
attract and retain senior management personnel. These and other
risks and uncertainties are described more fully in Aimmune's most
recent filings with the Securities and Exchange Commission,
including its Quarterly Report on Form 10-Q for the quarter ended
March 31, 2020. All forward-looking statements contained in this
press release speak only as of the date on which they were made.
Aimmune undertakes no obligation to update such statements to
reflect events that occur or circumstances that exist after the
date on which they were made.
This press release concerns PALFORZIA, which has been approved
for marketing by the FDA in the United States and has not been
approved for marketing by the EMA or Swissmedic. PALFORZIA in
Europe is currently limited to investigational use, and no
representation is made as to its safety or effectiveness for the
purposes for which it is being investigated.
PALFORZIA™, AIMMUNE®, AIMMUNE THERAPEUTICS® and CODIT™ are
trademarks of Aimmune Therapeutics, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20200608005186/en/
Investors: (650) 614-5220 ir@aimmune.com
Media: Julie Normart (559) 974-3245
jnormart@w2ogroup.com
Lauren Barbiero (646) 564-2156 lbarbiero@w2ogroup.com
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