Business Wire

Stallergenes Greer Announces Publication of Positive Results for PALFORZIA® Phase 3 Study in Peanut-allergic Children Aged 1 to 3 Years

Share

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: https://evidence.nejm.org/doi/full/10.1056/EVIDoa2300145

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 profile to 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 www.stallergenesgreer.com

------------------------

  1. 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.
  2. 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

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Communications
Catherine Kress
Tel: +33 (0)1 55 50 26 05
Email: catherine.kress@stallergenesgreer.com

About Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Suzano Invests R$18.6 Billion in 202329.2.2024 11:42:00 CET | Press release

Suzano, the world’s largest pulp producer, announces its financial statements for the full fiscal year of 2023. Total investment of R$18.6 billion in 2023, a 14% increase on FY22 FY23 Net revenues of R$39.8 billion, a 20% decrease on FY22 FY23 Adjusted EBITDA of R$18.3 billion, a 35% decrease on FY22 FY23 Operating cash generation of R$11.6 billion, a 49% decrease on FY22 FY23 Pulp sales totalled 10.2 million tons, a 4% decrease on FY22 FY23 Paper sales totalled 1.3 million tons, a 1% decrease on FY22 Despite the marked decline in global pulp prices over the course of 2023, Suzano has invested over R$18bn to guarantee its future success. It is currently finalising the construction of the Cerrado Project, the world’s largest single-line pulp mill, and has expanded its forestry estate, safeguarding supply and enhancing future competitiveness. Walter Schalka, CEO of Suzano, said: “Our investment cycle, including the highest annual investment ever, in 2023, represents the largest in our ce

H2SITE Has Commissioned a Membrane Separator Capable of Extracting 5 to 20% Hydrogen Blends at +99% Purity From the Gas Distribution Network29.2.2024 10:00:00 CET | Press release

H2SITE has successfully validated the feasibility of separating hydrogen (H2) blends ranging from 5% to 20% H2 concentration in regional distribution system operator (DSO) Nortegas' gas network, within the framework of the H2SAREA project. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240229560766/en/ The injection of hydrogen into the natural gas network is a solution that allows to leverage on existing infrastructure to transport low-carbon, renewable and pure hydrogen, provided that proper separation of this hydrogen can be carried out at the point of consumption at a limited cost. The several million kilometers of established natural gas transport and distribution networks worldwide will be a necessary asset in the transition towards low-carbon energy sources. Through the H2SAREA project, H2SITE has demonstrated that the distribution infrastructure is compatible with the transport of blends of hydrogen and renewable nat

Prysmian Digitally Transforms Warehousing Capabilities With Blue Yonder29.2.2024 09:00:00 CET | Press release

Prysmian, the world leader in the energy and telecom cable industry, has successfully completed the implementation for its Canadian warehouse of Blue Yonder’s SaaS-based Warehouse Management System (WMS) to support a more sustainable and customer-oriented supply chain. Prysmian is the largest cable producer in the world, with 30,000 associates and $16 billion in sales, specializing in the production of cable and systems for use in the energy and telecom industries. Prysmian is leading a digital transformation that is positively impacting customer service levels, as well as the sustainability of its supply chain execution. Prysmian was looking for a scalable solution, built for the connected world, as well as for a global supply chain solutions provider able to support warehousing operations across their worldwide differentiated business. Prysmian chose Blue Yonder to cover and improve their warehousing operations starting in North America, with the solution planned to become a standard

Aqara Introduces Smart Ceiling Light for Everyday and Atmospheric Illumination29.2.2024 09:00:00 CET | Press release

Aqara, a leading provider of smart home solutions, is thrilled to announce the expansion of its smart lighting product line with the introduction of the Ceiling Light T1M. This smart light fixture seamlessly blends radiant white lights with a colorful gradient ring for everyday and atmospheric illumination. The Ceiling Light T1M is available on Aqara’s Amazon brand stores in North America (US, Canada) and Europe (France, Germany, Italy, Poland, Spain, UK) as well as through select Aqara retailers worldwide*. Designed for rooms ranging from 5 to 20 square meters (approximately 54 to 215 square feet), this ceiling light offers a versatile lighting solution. With a spectrum ranging from warm-to-cool whites (2700-6500K) to an impressive 16 million colors, users can effortlessly create the perfect ambiance for any mood or occasion. Moreover, its independently addressable RGB ring enables seamless integration into holistic smart home experiences, allowing users to visually receive notificati

Denodo Recognized as a Leader in Enterprise Data Fabric Evaluation by Independent Analyst Firm29.2.2024 08:30:00 CET | Press release

Denodo, a leader in data management, today announced that Forrester Research, Inc. has positioned Denodo as a Leader in The Forrester Wave™: Enterprise Data Fabric, Q1 2024. According to the report, “Denodo is a great fit for customers focusing on an enterprise-wide data fabric strategy to support real-time analytics, customer 360, data engineering, data science, IoT analytics, operational insights, and predictive analytics use cases.” Denodo and 14 other vendors were evaluated across 26 criteria, including current offering, strategy, and market presence. The complete and complimentary report, published on February 28, is available here. The Wave revealed that while data fabric traditionally focused on read-only analytical use cases, there is a notable shift towards transactional fabric, with bidirectional read-and-write capabilities to support modern applications such as microservices and real-time customer experience. Today, enterprises are leveraging data fabric to accelerate new an

HiddenA line styled icon from Orion Icon Library.Eye