Home Food Allergies Optimistic Outcomes from Section 3 Examine of PALFORZIA® in Peanut-Allergic Youngsters Aged...

Optimistic Outcomes from Section 3 Examine of PALFORZIA® in Peanut-Allergic Youngsters Aged 1 to three Years

15
0

  • Outcomes Will likely be Offered for the First Time on the American School of Allergy, Bronchial asthma & Immunology (ACAAI) 2022 Annual Scientific Assembly
  • 73.5% of Sufferers Handled with PALFORZIA Met the Major End result at 12 Months In contrast with 6.3% of Sufferers within the Placebo Arm
  • 61% of Sufferers Handled with PALFORZIA Tolerated 2,000 mg of Peanut Protein In the course of the 12-Month Exit Meals Problem
  • 2% of Sufferers Handled with PALFORZIA Skilled PALFORZIA-Associated Systemic Allergic Reactions

BRISBANE, Calif.–(BUSINESS WIRE)–Aimmune Therapeutics, Inc., a Nestlé Well being Science firm creating pharmaceutical therapies to forestall, handle, and deal with meals, gastrointestinal (GI), and metabolic-related illnesses, will current for the primary time outcomes from the Section 3 POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) research. The trial evaluated the efficacy and security of PALFORZIA®[Peanut (Arachis hypogaea) AllergenPowder-dnfp] in peanut-allergic youngsters aged 1 to three years. These findings can be introduced on the American School of Allergy, Bronchial asthma & Immunology (ACAAI) 2022 Annual Scientific Assembly in Louisville, Kentucky on Saturday, November 12, 2022.

The research met the first consequence, with the vast majority of sufferers handled with PALFORZIA tolerating not less than a 600 mg single dose (1,043 mg cumulative) or 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 degree of two,000 mg (4,043 mg cumulative), and the median highest tolerated dose of peanut elevated 66-fold between baseline and exit DBPCFC.

PALFORZIA demonstrated a good security profile. General, 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 hostile occasions (AEs), and systemic allergic reactions attributable to any trigger had been related between PALFORZIA and placebo-treated sufferers (8.1% and eight.3%, respectively). Remedy-related systemic allergic reactions occurred in 2% of PALFORZIA-treated sufferers and 0% of placebo-treated sufferers.

“These outcomes point out that therapy with PALFORZIA in younger youngsters resulted in a clinically significant change within the quantity of peanut they may tolerate throughout oral problem,” stated Stephen Tilles, M.D., Senior Medical Director and International Head of Medical Affairs, Allergy for Aimmune Therapeutics. “At the moment, there’s a excessive unmet want for these younger youngsters with peanut allergy who depend on avoidance alone, and therapy at this early age presents a singular window of alternative to actively handle their peanut allergy close to the time of analysis.”

Peanut allergy is without doubt one of the commonest meals allergic reactions on the earth, affecting greater than 1.6 million youngsters and teenagers within the U.S. i Reactions to peanut are doubtlessly life-threatening, accounting for almost all of deaths associated to meals allergy.ii

“In my therapy of kids aged 4 by means of 17 with PALFORZIA, I’ve seen firsthand the advantages of this remedy,” stated George du Toit, M.B., B.Ch., Professor of Pediatric Allergy at Evelina London Youngsters’s Hospital, Man’s and St Thomas’ NHS Basis Belief, King’s School London and research investigator in PALFORZIA medical trials. “I’m now inspired by these promising ends in youthful youngsters, which present that almost all of research contributors tolerated a dose of 600mg of peanut protein – the equal of two peanut kernels – after 12 months of therapy, and no extreme systemic allergic reactions and solely rare mild-moderate systemic allergic reactions reported amongst PALFORZIA-treated contributors.”

“Dad and mom of kids with peanut allergy could not be capable of consistently supervise them outdoors of the house to keep away from unintended publicity to peanut,” stated Amy M. Scurlock, M.D., Professor of Pediatrics, College of Arkansas for Medical Sciences and Arkansas Youngsters’s Hospital. “The encouraging outcomes of the POSEIDON research point out that PALFORZIA has the potential to be an efficient and handy therapy possibility for peanut-allergic youngsters aged 1 to three years. These outcomes are welcome information for the numerous mother and father and younger youngsters impacted by this situation.”

PALFORZIA is at present authorised by the FDA as an oral immunotherapy (OIT) for the mitigation of allergic reactions, together with anaphylaxis, which will happen with unintended publicity to peanut in sufferers aged 4 by means of 17 years with a confirmed analysis of peanut allergy.

Aimmune plans to submit the complete POSEIDON research outcomes for publication in a peer-reviewed journal and submit these research outcomes to the FDA within the first half of 2023 to assist using PALFORZIA in applicable peanut-allergic youngsters aged 1-3 years, topic to overview and approval by FDA.

POSEIDON Outcomes

POSEIDON enrolled 146 sufferers, with 98 randomized to PALFORZIA and 48 randomized to placebo. General, 84.7% of sufferers on PALFORZIA and 93.8% of sufferers on placebo accomplished the research.

Efficacy outcomes:

  • 73.5% and 68.4% of sufferers handled with PALFORZIA tolerated a single dose of 600 mg and 1,000 mg of peanut protein in contrast with 6.3% and 4.2% of sufferers within the placebo group, respectively, with a therapy distinction of 67.2% and 64.2% (p<0.0001 for each).
  • 61.2% of PALFORZIA-treated sufferers tolerated the very best dose degree within the exit DBPCFC of two,000 mg (cumulative 4,043 mg) in contrast with 2.1% of placebo-treated sufferers, with a therapy distinction of 59.1% (p<0.0001).

Key security outcomes:

  • The most typical AEs associated to PALFORZIA therapy concerned the pores and skin and subcutaneous tissues (urticaria, erythema), the gastrointestinal system (belly ache, vomiting), and the respiratory, thoracic and mediastinal system (cough, sneezing).
  • 5.1% of PALFORZIA-treated sufferers versus 2.1% of placebo-treated sufferers skilled early withdrawal attributable to AEs.
  • 6.1% of PALFORZIA-treated sufferers versus 4.2% of placebo-treated sufferers skilled critical AEs. None had been associated to therapy.
  • 2% of PALFORZIA-treated sufferers versus 0% of placebo-treated sufferers skilled systemic allergic reactions (SARs; anaphylactic reactions of any severity) associated to therapy. SARs are defined based on the Nationwide Institute of Allergy and Infectious Illness standards and graded utilizing the 3-point Muraro (European Academy of Allergy and Scientific Immunology) grading scale.
  • SARs had been related between PALFORZIA-treated and placebo-treated sufferers (8.1% and eight.3%, respectively).
  • There have been no extreme or critical systemic allergic reactions.
  • 3.1% of PALFORZIA-treated sufferers versus 0% of placebo-treated sufferers used epinephrine for a treatment-related AEs.

Abstracts to be introduced by Aimmune on the ACAAI convention embody:

  • Oral Immunotherapy In Youngsters Aged 1 To <4 Years With Peanut Allergy: POSEIDON Trial Outcomes, Saturday, November 12, 4:43-4:53 p.m. ET
  • Well being-Associated High quality of Life in Youngsters and Caregiver Proxies from Trials of Peanut Oral Immunotherapy, Saturday, November 12, 5:13-5:23 p.m. ET
  • Manufacturing Processes and Standardization of Allergen Efficiency of Peanut (Arachis hypogaea) Allergen Powder-dnfp, Friday, November 11, 4:00-4:15 p.m. ET
  • Oral Immunotherapy in Youngsters with Peanut Allergy Alone or with Different Meals Allergy in PALISADE, Friday, November 11, 4:15-4:30 p.m. ET
  • Affected person and caregiver views on therapy with licensed peanut allergy oral immunotherapy in follow, Friday, November 11, 3:15-3:30 p.m. ET

About POSEIDON

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 trial that evaluated the efficacy and security of PALFORZIA in peanut-allergic youngsters aged 1 to three in North America and 4 European international locations. Enrollment was primarily based on stringent entry standards, together with a documented medical historical past of peanut allergy, constructive pores and skin prick assessments 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 constructive double-blind, placebo-controlled meals problem (DBPCFC). In POSEIDON, sufferers underwent a dose-escalation interval of roughly 22 weeks to achieve a dose of 300 mg per day of PALFORZIA or placebo, then continued on that dose for about six months. On the finish of the trial, sufferers underwent an exit DBPCFC.

About PALFORZIA® [Peanut (Arachis hypogaea) AllergenPowder-dnfp]

PALFORZIA was authorised in January 2020 by the U.S. Meals and Drug Administration (FDA) as an oral immunotherapy (OIT) for the mitigation of allergic reactions, together with anaphylaxis, which will happen with unintended publicity to peanut in sufferers aged 4 by means of 17 years with a confirmed analysis of peanut allergy. PALFORZIA was authorised on December 17, 2020 by the European Fee (EC), on April 7, 2021 by the Medicines and Healthcare merchandise Regulatory Company (MHRA) within the U.Ok., and on Might 4, 2021 by Swissmedic. Use of PALFORZIA could also be continued in sufferers 18 years of age and older. PALFORZIA shouldn’t be indicated for the emergency therapy of allergic reactions, together with anaphylaxis and should all the time be used at the side of a peanut-avoidant food regimen.

Boxed WARNING: PALFORZIA may cause anaphylaxis, which can be life threatening and may happen at any time throughout PALFORZIA remedy. Prescribe injectable epinephrine, instruct and practice sufferers on its applicable use, and instruct sufferers to hunt fast medical care upon its use. Don’t administer PALFORZIA to sufferers with uncontrolled bronchial asthma.

Please see U.S. Vital Security Data and Boxed WARNING beneath, or for full Prescribing Data, together with Boxed WARNING and Medicine Information, go to www.PALFORZIA.com.

INDICATION

PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, together with anaphylaxis, which will happen with unintended publicity to peanut. PALFORZIA is authorised to be used in sufferers with a confirmed analysis of peanut allergy. Preliminary Dose Escalation could also be administered to sufferers aged 4 by means of 17 years. Up-Dosing and Upkeep could also be continued in sufferers 4 years of age and older.

PALFORZIA is for use at the side of a peanut-avoidant food regimen.

Limitations of Use: Not indicated for the emergency therapy of allergic reactions, together with anaphylaxis.

IMPORTANT SAFETY INFORMATION

Boxed WARNING:

PALFORZIA may cause anaphylaxis, which can be life threatening and may happen at any time throughout PALFORZIA remedy.

Prescribe injectable epinephrine, instruct and practice sufferers on its applicable use, and instruct sufferers to hunt fast medical care upon its use.

Don’t administer PALFORZIA to sufferers with uncontrolled bronchial asthma.

Dose modifications could also be vital following an anaphylactic response.

Observe sufferers throughout and after administration of the Preliminary Dose Escalation and the primary dose of every Up-Dosing degree, for not less than 60 minutes.

PALFORZIA is obtainable solely by means of a restricted program referred to as the PALFORZIA REMS.

CONTRAINDICATIONS

PALFORZIA is contraindicated in sufferers with uncontrolled bronchial asthma, or with a historical past of eosinophilic esophagitis and different eosinophilic gastrointestinal illness.

WARNINGS AND PRECAUTIONS

Anaphylaxis

PALFORZIA may cause anaphylaxis, which can be life threatening. PALFORZIA is obtainable solely by means of a restricted program underneath a Threat Analysis and Mitigation Technique (REMS) referred to as the PALFORZIA REMS due to the chance of anaphylaxis. Solely prescribers, healthcare settings, pharmacies, and sufferers licensed and enrolled within the REMS Program can prescribe, obtain, dispense or administer PALFORZIA.

Anaphylaxis has been reported throughout all phases of PALFORZIA dosing, together with Upkeep and in topics who’ve undergone advisable Up-Dosing and dose modification procedures.

Don’t provoke PALFORZIA therapy in a affected person who has had extreme or life-threatening anaphylaxis inside the earlier 60 days. PALFORZIA might not be appropriate for sufferers with sure medical circumstances which will cut back the power to outlive anaphylaxis, together with however not restricted to markedly compromised lung perform, extreme mast cell dysfunction, or heart problems. As well as, PALFORZIA might not be appropriate for sufferers taking drugs that may inhibit or potentiate the consequences of epinephrine.

All Preliminary Dose Escalation doses and the primary dose of every Up-Dosing degree have to be administered in an authorized well being care setting.

Sufferers could also be extra prone to expertise allergic reactions following PALFORZIA administration within the presence of cofactors corresponding to train, sizzling water publicity, intercurrent sickness (e.g., viral an infection), or fasting. Different potential cofactors could embody menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled bronchial asthma. Sufferers must be proactively endorsed concerning the potential for the elevated danger of anaphylaxis within the presence of those cofactors. If attainable, regulate the time of dosing to keep away from these cofactors. If it’s not attainable to keep away from these cofactors, think about withholding PALFORZIA briefly.

Bronchial asthma

Uncontrolled bronchial asthma is a danger issue for a critical consequence, together with loss of life, in anaphylaxis. Guarantee sufferers with bronchial asthma have their bronchial asthma underneath management previous to initiation of PALFORZIA.

PALFORZIA must be briefly withheld if the affected person is experiencing an acute bronchial asthma exacerbation. Following decision of the exacerbation, resumption of PALFORZIA must be undertaken cautiously. Re-evaluate sufferers who’ve recurrent bronchial asthma exacerbations and think about discontinuation of PALFORZIA.

Eosinophilic Gastrointestinal Illness

Discontinue PALFORZIA and think about a analysis of eosinophilic esophagitis in sufferers who expertise extreme or persistent gastrointestinal signs, together with dysphagia, vomiting, nausea, gastroesophageal reflux, chest ache, or belly ache.

Gastrointestinal Adversarial Reactions

Gastrointestinal hostile reactions had been generally reported in PALFORZIA-treated topics, and dose modification must be thought-about for sufferers who report these reactions. For extreme or persistent gastrointestinal signs think about a analysis of eosinophilic esophagitis.

ADVERSE REACTIONS

The most typical hostile occasions reported in topics handled with PALFORZIA (incidence ≥ 5% and ≥ 5% than placebo) are belly ache, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic response, and ear pruritus.

For extra details about PALFORZIA, please name 1-844-PALFORZ (1-844-725-3679) or go to www.PALFORZIA.com.

Please see full U.S. Prescribing Data, together with Boxed WARNING, and Medicine Information at www.PALFORZIA.com.

About Aimmune Therapeutics

Aimmune Therapeutics, a part of Nestlé Well being Science, is a biopharmaceutical firm that aspires to be a worldwide chief in creating revolutionary medicines to forestall, handle, and deal with meals, gastrointestinal (GI), and metabolic-related illnesses for these with few or no therapy choices. Aimmune was constructed on the assumption that households deserve standardized, regulatory-approved, science-driven remedies that cut back their each day burden and assist them higher handle these circumstances.

For extra details about Aimmune, please go to www.aimmune.com

About Nestlé Well being Science

Nestlé Well being Science, a pacesetter within the science of diet, is a globally managed enterprise unit of Nestlé. We’re dedicated to redefining the administration of well being, providing an intensive portfolio of science-based client well being, medical diet, pharmaceutical therapies, and vitamin and complement manufacturers. Our intensive analysis community offers the muse for merchandise that empower more healthy lives by means of diet. Headquartered in Switzerland, we’ve got greater than 12,000 staff all over the world, with merchandise out there in additional than 140 international locations.www.nestlehealthscience.com

i Pawankar R, Canonica WG, Holgate ST, Lockey RF, Blaiss MS. Government Abstract. In: Pawankar R, Canonica WG, Holgate ST, Lockey RF, Blaiss MS. WAO White Guide on Allergy: Replace 2013. Milwaukee, WI: World Allergy Group; 2013:1-9.  Accessed August 31, 2022.

ii Bock SA, Muñoz-Furlong A, Sampson HA. Fatalities attributable to anaphylactic reactions to meals. J Allergy Clin Immunol. 2001;107:191-193.

Contacts

U.S. Media:
Georgina Vincent
+1.747.758.9524
gvincent@aimmune.com

Be aware of Disclosure: Aimmune Therapeutics is an advertiser with SnackSafely.com.