- Full POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) research information revealed in New England Journal of Drugs Proof.
- 73.5% of sufferers handled with PALFORZIA met the first endpoint of tolerating the 600 mg single dose of peanut protein at 12 months in contrast with 6.3% of sufferers receiving placebo.
- No critical or extreme treatment-related opposed occasions have been reported with the usage of PALFORZIA. Solely 2% of sufferers skilled systemic allergic reactions associated to the trial therapy.
- Proof of development of peanut allergy in sufferers receiving placebo however not in sufferers handled with PALFORZIA.
BAAR, Switzerland–(BUSINESS WIRE)–Stallergenes Greer, a number one international healthcare firm specialising in allergen immunotherapy (AIT), broadcasts the publication of outcomes from the Section 3 POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) research within the New England Journal of Drugs Proof. The research evaluated the efficacy and security of PALFORZIA [defatted powder of Arachis hypogaea L., semen (peanuts)] in peanut-allergic youngsters aged 1 to three years.
The research met the first endpoint, with the vast majority of sufferers handled with PALFORZIA tolerating a minimum of 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, in comparison with 6.3% and 4.2% of sufferers who acquired placebo, respectively). As well as, the vast majority of sufferers handled with PALFORZIA (61.2% in contrast with 2.1% of placebo-treated sufferers) tolerated the very best exit double-blind, placebo-controlled exit meals problem (DBPCFC) dose stage of two,000 mg (4,043 mg cumulative), and this proportion was greater for the youngest age group.
PALFORZIA demonstrated a good security profile. Total, 84.7% of sufferers on PALFORZIA and 93.8% of sufferers on placebo accomplished the research. There have been no PALFORZIA-related critical or extreme opposed occasions, and systemic allergic reactions resulting from any trigger have been comparable between PALFORZIA and placebo-treated sufferers (8.2% and eight.3%, respectively). Remedy-related systemic allergic reactions occurred in 2% of PALFORZIA-treated sufferers and 0% of placebo-treated sufferers.
A 3.5-fold improve in peanut allergy prevalence has been reported in recent times, with 1 to 2% of kids in Western international locations affected1. Reactions to peanut are probably life-threatening, accounting for almost all of deaths associated to meals allergy2.
“By way of the Poseidon research, we’ve witnessed a major shift in how peanut allergy will be managed within the youngest sufferers,” stated George du Toit, M.B., B.Ch., Professor of Pediatric Allergy at Evelina London Kids’s Hospital, Man’s and St Thomas’ NHS Basis Belief, King’s Faculty London and research investigator in PALFORZIA scientific trials. “These findings spotlight the potential good thing about early intervention for peanut-allergic youngsters aged 1 to three years, providing a glimpse of hope for a future the place we are able to alleviate the burden of this situation.”
“We’re delighted concerning the outcomes which underscore the scientific significance of PALFORZIA for peanut-allergic toddlers. The outcomes, revealed within the New England Journal of Drugs Proof, are actually promising and probably life-changing for younger sufferers. The latest addition of PALFORZIA, the primary standardised therapy for peanut-allergic toddlers, to Stallergenes Greer’s portfolio is testimony to our unwavering dedication to offer sufferers and the medical group with revolutionary AIT remedies,” says Amer Jaber, Chief Innovation Officer of Stallergenes Greer.
To learn the publication:
ABOUT POSEIDON PHASE 3 STUDY
POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization, clinicaltrials.gov quantity NCT03736447) is a global, randomized (2:1), double-blind, placebo-controlled Section 3 research that evaluated the efficacy and security of PALFORZIA in peanut-allergic youngsters aged 1 to <4 years of age in North America and Europe. The POSEIDON research was accomplished by Aimmune Therapeutics, a part of Nestlé Well being Science earlier than Nestlé divested PALFORZIA to Stallergenes Greer in September 2023. Enrollment was based mostly on a number of entry standards, together with a documented scientific historical past of peanut allergy, optimistic pores and skin prick checks and/or elevated blood ranges of peanut antibodies, and dose-limiting signs after consuming single doses of peanut protein >3 to ≤300 mg in a optimistic double-blind, placebo-controlled meals problem (DBPCFC). In POSEIDON, sufferers underwent a dose-escalation interval of roughly 22 weeks to succeed in a dose of 300 mg per day of PALFORZIA or placebo, then continued that dose for about six months. On the finish of the trial, sufferers underwent an exit DBPCFC.
PALFORZIA is a fancy biologic drug used with a structured dosing strategy that builds on a century of oral immunotherapy (OIT) analysis. With OIT, the particular allergenic proteins are ingested initially in very small portions, adopted by incrementally rising quantities, that can lead to the flexibility 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 profile to guarantee the consistency of each dose, from 0.5 mg (equal to 1/600th of a peanut) to 300 mg.
PALFORZIA shouldn’t be supposed for, and doesn’t present, instant aid of allergic signs. Subsequently, this medicinal product shouldn’t be for use for emergency therapy of allergic reactions, together with anaphylaxis. Self-injectable adrenaline (epinephrine) have to be out there to the affected person always.
PALFORZIA is accepted by the U.S. Meals and Drug Administration (FDA) by the European Drugs Company (EMA), by the Medicines and Healthcare merchandise Regulatory Company (MHRA) within the U.Ok., and by Swissmedic in Switzerland.
ABOUT STALLERGENES GREER INTERNATIONAL AG
Headquartered in Baar (Switzerland), Stallergenes Greer Worldwide AG is a worldwide healthcare firm specialising within the prognosis and therapy of respiratory and meals allergy symptoms via the analysis, improvement and commercialisation of allergen immunotherapy services. Stallergenes Greer Worldwide AG is the mum or dad firm of Greer Laboratories, Inc. (whose registered workplace is in america) and Stallergenes SAS (whose registered workplace is in France). For extra data, go to www.stallergenesgreer.com
- Lange L, Klimek L, Beyer Ok, et al. White paper on peanut allergy. Half 1: epidemiology, burden of illness, well being financial points. Allergo j Int 2021;30:261-269. DOi: 10.1007 / s40629-021-00189-z.
- Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities resulting from anaphylactic reactions to meals. J Allergy Clin Immunol. 2001;107:191-193.
PALFORZIA: © 2023, Société des Produits Nestlé S.A. or its associates