– Two-year PALFORZIA® ▼ [defatted powder of Arachis hypogaea L., semen (peanuts)] data show patients report treatment is convenient and easy to use –
– Additional poster exploring preliminary insights on longer-term safety outcomes from ongoing, Phase 3 ARC008 study to be presented –
LONDON–(BUSINESS WIRE)–Aimmune Therapeutics UK Ltd., a Nestlé Health Science company developing and commercialising pharmaceutical therapies to prevent, manage, and treat food and metabolic related diseases, today announced it will present new treatment satisfaction data for its oral immunotherapy drug, PALFORZIA, at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021 in Poland. The company will share updated treatment satisfaction data evaluated in its Phase 3, randomised, double-blind, placebo-controlled trial, PALISADE, and open-label follow-on trial, ARC004.
Patient-reported treatment satisfaction was evaluated over two years following daily treatment with PALFORZIA in a clinical trial setting using the Treatment Satisfaction Questionnaire for Medication (TSQM-9). Peanut allergic participants reported overall satisfaction with the effectiveness and convenience items, as well as the medication’s ability to treat their condition.
“Patient-centricity is an essential pillar of clinical development, and we look forward to presenting these encouraging patient satisfaction data,” said Andrew Oxtoby, President and Chief Executive Officer of Aimmune Therapeutics. “We know efficacy and safety remain the traditional, crucial endpoints assessed; however, true clinical and medical progress requires a deep understanding of the patient experience – what the patient values and needs for a positive outcome.”
Additional data to be presented at EAACI include an update on the ongoing Phase 3 ARC008 open-label study which is looks at longer-term safety in patients. The data collected by this study will help facilitate discussions around the longer-term safety with clinicians, peanut-allergic individuals, and their families.
Full details of the oral and poster presentations can be found below.
Oral Presentation
Title: Treatment satisfaction with continued oral immunotherapy for peanut allergy: results after 1, 1.5, and 2 years of daily therapy
Presenter: Katharina Blümchen, MD, University Hospital Frankfurt (Germany)
Session Title: OAS 01 New perspectives in allergen immunotherapy
Date/Time: July 10, 3:05-3:13pm CEST
Poster Presentation
Title: Longer-term safety outcomes of defatted powder of Arachis hypogaea L. semen (peanuts) in subjects from prior clinical trials (ARC008): a trial-in-progress and preliminary insights
Poster: 247
Presenter: Kirsten Beyer, MD, University Hospital Charité (Germany)
Session title: ePoster Allergen Immunotherapy
Date/Time: July 10, 9am-8:30pm CEST
About PALFORZIA
PALFORZIA was approved in December 2020 by the European Commission (EC) for patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy in conjunction with a peanut-avoidant diet. PALFORZIA may be continued in patients 18 years of age and older.
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 approximately 1/600th of a peanut kernel) 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.
Please see full summary of product characteristics at www.aimmune.co.uk/our-product.
About Aimmune
Aimmune Therapeutics UK Ltd., a Nestlé Health Science company, is a biopharmaceutical company developing and commercialising pharmaceutical therapies to prevent, manage, and treat food and metabolic related diseases. For more information, please visit www.aimmune.co.uk.
About Nestlé Health Science
Nestlé Health Science (NHSc), a wholly owned subsidiary of Nestlé, is a globally recognised leader in the field of nutritional science. At NHSc we are committed to empowering healthier lives through nutrition for consumers, patients and their healthcare partners. We offer an extensive consumer health portfolio of industry-leading medical nutrition, consumer and vitamins, minerals and supplements (VMS) brands that are science-based solutions covering all facets of health from prevention, to maintenance, all the way through to treatment. NHSc is redefining the way we approach the management of health in several key areas such as pediatric health, allergy, acute care, oncology, metabolic health, healthy aging, gastrointestinal health, and inborn errors of metabolism. Headquartered in Switzerland, NHSc employs over 5,000 people around the world who are committed to making a difference in people’s lives, for a healthier today and tomorrow. www.nestlehealthscience.com.
Contacts
Europe Media:
Jemini Sedani
+44 7940 594788
jsedani@realchemistry.com