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LONDON, UK / ACCESSWIRE / February 22, 2018 / Active-Investors.com has just released a free research report on Aimmune Therapeutics, Inc. (NASDAQ: AIMT). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=AIMT as the Company's latest news hit the wire. On February 20, 2018, the California-based biopharmaceutical Company announced that its pivotal Phase-3 clinical trial, PALISADE (Peanut Allergy Oral Immunotherapy Study of AR101 for Desensitization in Children and Adults), evaluating its lead candidate AR101 for treating severe peanut allergy has met the primary endpoint. Register today and get access to over 1,000 Free Research Reports by joining our site below:
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Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Aimmune Therapeutics most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
PALISADE was an international randomized 3:1, double-blind, placebo-controlled, Phase-3 trial of the efficacy and safety of AR101 in a Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach in patients with peanut allergy. In the study, 496 highly allergic patients of the ages 4–17 received the treatment. PALISADE enrolled peanut-allergic patients ages at more than 60 clinical sites in the United States, Canada, and eight countries in the European Union.
Results of the Trial
After one year of treatment, 76.6% of participants treated with AR101 tolerated 300 mg of peanut protein compared to 8.1% for placebo, in the exit double-blind, placebo-controlled food challenge (DBPCFC). Around 67.2% of patients tolerated at least a 600-mg dose of peanut protein compared to 4% of placebo patients. Additionally, 50.3% of AR101 patients tolerated a single highest dose of 1,000 mg of peanut protein compared to 2.4% of placebo patients. The participants could tolerate no more than 30 mg of peanut protein at study entry. The pre-specified success criterion was 15%. Aimmune cleared this statistical requirement with a 53% difference. Incidences of serious adverse events (SAEs) were low. A total of 10 patients experienced SAEs, none of which were considered life-threatening. Nine of these patients were in the AR101 arm. Of the nine AR101 patients who experienced a SAE, five patients experienced mild or moderate SAEs, and the other four experienced severe SAEs.
Aimmune Plans to Seek Approval in United States and Europe for AR101
Based on the results, Aimmune expects to submit a Biologics License Application (BLA) for AR101 with the FDA by the end of 2018, followed by a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) in the first half of 2019. In the United States, AR101 has FDA Fast Track Designation as well as FDA Breakthrough Therapy Designation for peanut-allergic patients ages 4–17.
PALISADE is the Largest Peanut Allergy Trial Ever Conducted
Daniel C. Adelman, M.D., Chief Medical Officer of Aimmune, mentioned that PALISADE is not only the largest peanut allergy trial ever conducted, it is also the first to use an independent blinded assessor, and the first to accept peanut-allergic patients with a history of severe or life-threatening reactions.
Daniel added that given how robust the PALISADE results are and that they met or exceeded the pre-specified metrics, the Company is encouraged that the data from PALISADE are helping to define the magnitude of the potential treatment effect in very sensitive peanut-allergic patients.
About Peanut Allergy
Peanut allergy is a type of food allergy to peanuts. It is different from tree nut allergies. Physical symptoms of allergic reaction can include itchiness, urticaria, swelling, eczema, sneezing, asthma, abdominal pain, drop in blood pressure, diarrhea, and cardiac arrest. Anaphylaxis may occur. It is due to a type-I hypersensitivity reaction of the immune system in susceptible individuals. The allergy is recognized as one of the most severe food allergies due to its prevalence, persistency, and potential severity of allergic reaction. Currently, there is no cure for peanut allergy.
AR101, Aimmune's lead investigational drug, is an investigational oral biologic drug designed to help protect patients from severe allergic reactions in case they are accidentally exposed to peanut. AR101, upon regulatory approval, would meet the stringent manufacturing and quality requirements established by regulatory authorities.
About Aimmune Therapeutics, Inc.
Founded in 2011, Aimmune Therapeutics is a clinical-stage biopharmaceutical company developing desensitization treatments to protect people with food allergies from the life-threatening consequences of accidental exposures to their allergens. The Company is headquartered in Brisbane, California.
Stock Performance Snapshot
February 21, 2018 - At Wednesday's closing bell, Aimmune Therapeutics' stock fell 7.87%, ending the trading session at $32.21.
Volume traded for the day: 2.46 million shares, which was above the 3-month average volume of 484.77 thousand shares.
Stock performance in the previous six-month period – up 67.32%; and past twelve-month period – up 60.49%
After yesterday's close, Aimmune Therapeutics' market cap was at $1.68 billion.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
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