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Stallergenes Greer
Announces Publication of Positive Results for
PALFORZIA
® Phase 3 Study in Peanut-allergic Children Aged 1 to 3 Years
2023-11-20
·
BioSpace
临床结果
免疫疗法
临床3期
上市批准
Full POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study data published in New England Journal of Medicine Evidence. 73.5% of patients treated with
PALFORZIA
met the primary endpoint of tolerating the 600 mg single dose of peanut protein at 12 months compared with 6.3% of patients receiving placebo. No serious or severe treatment-related adverse events were reported with the use of
PALFORZIA
. Only 2% of patients experienced systemic allergic reactions related to the trial treatment. Evidence of progression of
peanut allergy
in patients receiving placebo but not in patients treated with
PALFORZIA
. BAAR, Switzerland--(BUSINESS WIRE)--
Stallergenes Greer
, a leading global healthcare company specialising in allergen immunotherapy (AIT), announces the publication of results from the Phase 3 POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study in the New England Journal of Medicine Evidence. The study evaluated the efficacy and safety of
PALFORZIA
[defatted powder of Arachis hypogaea L., semen (peanuts)] in
peanut-allergic
children aged 1 to 3 years. The study met the primary endpoint, with the majority of patients treated with
PALFORZIA
tolerating at least a 600 mg single dose (1,043 mg cumulative) or a 1,000 mg single dose (2,043 mg cumulative) of peanut protein (73.5% and 68.4%, respectively, compared to 6.3% and 4.2% of patients who received placebo, respectively). In addition, the majority of patients treated with
PALFORZIA
(61.2% compared with 2.1% of placebo-treated patients) tolerated the highest exit double-blind, placebo-controlled exit food challenge (DBPCFC) dose level of 2,000 mg (4,043 mg cumulative), and this proportion was higher for the youngest age group.
PALFORZIA
demonstrated a favorable safety profile. Overall, 84.7% of patients on
PALFORZIA
and 93.8% of patients on placebo completed the study. There were no
PALFORZIA
-related serious or severe adverse events, and
systemic allergic reactions
due to any cause were similar between
PALFORZIA
and placebo-treated patients (8.2% and 8.3%, respectively). Treatment-related
systemic allergic reactions
occurred in 2% of
PALFORZIA
-treated patients and 0% of placebo-treated patients. A 3.5-fold increase in
peanut allergy
prevalence has been reported in recent years, with 1 to 2% of children in Western countries affected1. Reactions to peanut are potentially life-threatening, accounting for the majority of deaths related to
food allergy2
. “Through the Poseidon study, we have witnessed a significant shift in how
peanut allergy
can be managed in the youngest patients,” said George du Toit, M.B., B.Ch., Professor of
Pediatric Allergy
at Evelina London Children’s Hospital, Guy's and St Thomas' NHS Foundation Trust,
King’s College London
and study investigator in
PALFORZIA
clinical trials. “These findings highlight the potential benefit of early intervention for
peanut-allergic
children aged 1 to 3 years, offering a glimpse of hope for a future where we can alleviate the burden of this condition.” “We are delighted about the results which underscore the clinical significance of
PALFORZIA
for
peanut-allergic
toddlers. The results, published in the New England Journal of Medicine Evidence, are truly promising and potentially life-changing for young patients. The recent addition of
PALFORZIA
, the first standardised treatment for
peanut-allergic
toddlers, to
Stallergenes Greer
’s portfolio is testimony to our unwavering commitment to provide patients and the medical community with innovative AIT treatments,” says Amer Jaber, Chief Innovation Officer of
Stallergenes Greer
. To read the publication: ABOUT POSEIDON PHASE 3 STUDY POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, clinicaltrials.gov number NCT03736447) is an international, randomized (2:1), double-blind, placebo-controlled Phase 3 study that evaluated the efficacy and safety of
PALFORZIA
in
peanut-allergic
children aged 1 to <4 years of age in North America and Europe. The POSEIDON study was completed by
Aimmune Therapeutics
, part of
Nestlé Health Science
before
Nestlé
divested PALFORZIA to
Stallergenes Greer
in September 2023. Enrollment was based on several entry criteria, including a documented clinical history of
peanut allergy
, positive skin prick tests and/or elevated blood levels of peanut antibodies, and dose-limiting symptoms after consuming single doses of peanut protein >3 to ≤300 mg in a positive double-blind, placebo-controlled food challenge (DBPCFC). In POSEIDON, patients underwent a dose-escalation period of approximately 22 weeks to reach a dose of 300 mg per day of
PALFORZIA
or placebo, then continued that dose for approximately six months. At the end of the trial, patients underwent an exit DBPCFC. ABOUT
PALFORZIA
PALFORZIA
is a complex biologic drug used with a structured dosing approach that builds on a century of oral immunotherapy (OIT) research. With OIT, the specific allergenic proteins are ingested initially in very small quantities, followed by incrementally increasing amounts, that can result in the ability to mitigate allergic reactions to the allergen over time.
PALFORZIA
is a rigorously developed, pharmaceutical-grade OIT for
peanut allergy
with a well-defined allergen pro assure the consistency of every dose, from 0.5 mg (equivalent to 1/600th of a peanut) to 300 mg.
PALFORZIA
is not intended for, and does not provide, immediate relief of allergic symptoms. Therefore, this medicinal product is not to be used for emergency treatment of
allergic reactions
, including
anaphylaxis
. Self-injectable adrenaline (epinephrine) must be available to the patient at all times.
PALFORZIA
is approved by the
U.S. Food and Drug Administration (FDA)
by the
European Medicine Agency (EMA)
, by the
Medicines and Healthcare products Regulatory Agency (MHRA)
in the U.K., and by
Swissmedic
in Switzerland. ABOUT STALLERGENES GREER INTERNATIONAL AG Headquartered in Baar (Switzerland), Stallergenes Greer International AG is a global healthcare company specialising in the diagnosis and treatment of
respiratory and food allergies
through the research, development and commercialisation of allergen immunotherapy products and services. Stallergenes Greer International AG is the parent company of
Greer Laboratories, Inc.
(whose registered office is in the United States) and
Stallergenes SAS
(whose registered office is in France). For more information, visit ------------------------ Lange L, Klimek L, Beyer K, et al. White paper on
peanut allergy
. Part 1: epidemiology, burden of disease, health economic aspects. Allergo j Int 2021;30:261-269. DOi: 10.1007 / s40629-021-00189-z. Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities due to anaphylactic reactions to foods. J Allergy Clin Immunol. 2001;107:191-193. PALFORZIA: © 2023,
Société des Produits Nestlé S.A.
or its affiliates
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机构
Stallergenes Greer Ltd.
King's College London
Aimmune Therapeutics, Inc.
[+9]
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食物过敏
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