Peanut

Novel Toothpaste-Based Immunotherapy Shows Promise for Peanut Allergy Treatment in Phase 1 Trial

3 months ago

• Intrommune Therapeutics' Phase 1 OMEGA study demonstrates successful safety profile of innovative toothpaste-based peanut allergy treatment, with all participants tolerating their highest assigned dose. • The novel Oral Mucosal Immunotherapy (OMIT) platform, utilizing INT301 peanut protein in toothpaste, achieved a remarkable 97% adherence rate among adult participants. • Study results show no severe systemic reactions or anaphylaxis, with only mild, localized reactions reported, marking a potential breakthrough in food allergy treatment convenience.

NIH Trial Shows Home-Based Peanut Butter Therapy Successfully Treats High-Threshold Peanut Allergies

3 months ago

• A groundbreaking NIH-sponsored trial demonstrated 100% success rate in helping children with high-threshold peanut allergies tolerate up to three tablespoons of peanut butter through gradual exposure therapy. • The 18-month treatment protocol, using store-bought peanut butter with home-measured doses, offers a safe and accessible option for approximately 800,000 U.S. children with high-threshold peanut allergies. • The study showed 68.4% of treated participants achieved sustained unresponsiveness to peanuts, compared to only 8.6% natural tolerance development in the avoidance group.

Aravax Appoints Aled Williams as CBO to Spearhead International Expansion of Peanut Allergy Therapy PVX108

4 months ago

• Aravax appointed Aled Williams as Chief Business Officer to bolster its international presence and strategic partnerships. • Williams will focus on expanding the Aravax portfolio and advancing the asset strategy, leveraging his 25 years of biotech and pharma experience. • The appointment supports the Phase 2 development of PVX108, Aravax's lead immunotherapy for peanut allergy, designed for safer and more targeted treatment. • Aravax aims to establish itself as a leader in food allergy treatments through innovative immunotherapies and strategic global outreach.

Palforzia Receives European Commission Approval for Peanut Allergy Treatment in Toddlers

4 months ago

• The European Commission has approved Palforzia for treating peanut allergies in toddlers aged 1-3, expanding its availability in Europe. • This approval follows the FDA's decision in July 2024, making Palforzia the only oral immunotherapy approved for this age group in both regions. • Palforzia aims to desensitize patients by gradually increasing tolerance to peanuts, reducing the risk of severe allergic reactions from accidental exposure. • The approval is based on the Phase 3 POSEIDON study, which demonstrated Palforzia's efficacy and safety in young children with peanut allergies.

ALK's Peanut Allergy Tablet Shows Positive Results, Advances to Phase II

5 months ago

• ALK's sublingual immunotherapy (SLIT) tablet for peanut allergy demonstrated safety and tolerability across multiple doses in a Phase I/II trial. • Based on Phase I/II results, the peanut tablet development is advancing to Phase II to evaluate dose finding and efficacy. • The Phase II trial, involving approximately 125 patients in the USA and Canada, is expected to be completed in 2026, with first patients dosed imminently.

Viaskin Peanut Patch Shows Promise in Toddlers with Peanut Allergy, Gains FDA Accelerated Approval Pathway

6 months ago

• DBV Technologies' Viaskin Peanut patch demonstrates sustained benefits over 36 months in toddlers aged 1-3, improving treatment efficacy and safety. • The FDA has granted an Accelerated Approval pathway for Viaskin Peanut, acknowledging its potential as a significant advancement over existing therapies for peanut allergy. • Data from the EPITOPE Phase 3 trial supports the proposed labeling strategy, highlighting the importance of consistent patch wear time for optimal clinical response. • A confirmatory study with the commercial version of Viaskin Peanut will be conducted to validate its safety and efficacy, with BLA submission expected in 2H 2026.

IgGenix Doses First Patient in Phase 1 Trial of IGNX001 for Peanut Allergy

6 months ago

• IgGenix has dosed the first patient in its Phase 1 ACCELERATE Peanut trial, evaluating IGNX001, a novel monoclonal antibody for peanut allergy. • IGNX001 neutralizes peanut proteins by attaching to them, preventing interaction with allergy cells, offering a different mechanism from existing immunotherapies. • The Phase 1 trial is a randomized, multi-center, double-blind, placebo-controlled study assessing safety, tolerability, and proof of mechanism in adults and adolescents. • Topline data from the trial, conducted in Australia, is expected in mid-2025, with recruitment ongoing for individuals aged 15-55 with peanut allergy.

Lurie Children's Advances Peanut Allergy Immunotherapy with Novel Approaches

9 months ago

• Lurie Children's Hospital is conducting clinical trials for peanut allergies, focusing on reducing the risk of severe reactions from accidental exposure. • A Phase 3 trial is underway, evaluating a peanut protein skin patch (Viaskin) for children aged 4-7, aiming for improved tolerability over oral immunotherapy. • An early-stage trial is testing a sublingual tablet for peanut desensitization in participants aged 4-25, assessing safety and effectiveness. • These immunotherapies seek to alleviate anxiety by minimizing severe reaction risks, though strict allergen avoidance remains necessary.

DBV Technologies Announces Positive Topline Results from Phase 3 EPITOPE Trial of Viaskin Peanut in Peanut-Allergic Toddlers

3 years ago

DBV Technologies has announced positive topline results from its Phase 3 EPITOPE trial, evaluating the safety and efficacy of Viaskin Peanut in treating peanut-allergic toddlers aged 1 to 3 years. The trial met its primary endpoint, showing a significant treatment effect with 67.0% of subjects in the Viaskin Peanut arm meeting response criteria at 12 months, compared to 33.5% in the placebo arm.

Drug Development Updates