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Is Relief On The Way For Peanut Allergy?

(RTTNews) - Peanut allergy, a condition in which the immune system mistakenly recognizes a number of proteins from peanuts as potential foreign pathogens, triggering an inflammation, is most common in children. The rate of peanut allergy is on the rise - with approximately 2 percent of children, roughly 1.5 million children in the U.S., being affected, according to the Jaffe Food Allergy Institute.

Sometimes peanut allergy can cause a life-threatening reaction like anaphylaxis that requires immediate medical attention. *Anaphylaxis is a severe allergic reaction accompanied by flushing, itching, nasal congestion, wheezing, difficulty breathing, drop in blood pressure, and swelling of the throat and tongue, sometimes accompanied by nausea, vomiting, and diarrhea. (Source: Harvard Medical School).

An immediate injection of epinephrine (adrenaline) can prevent food-induced anaphylaxis from turning fatal.

The peanut allergy usually continues into adulthood and only 20% of the children outgrow it. There is no treatment yet for peanut allergy, and the best way to prevent an allergic reaction is to avoid foods that contain peanuts.

According to a March 2018 report published by Prescient & Strategic (P&S) Intelligence, there are 19 drug candidates in the peanut allergy therapeutics pipeline that are in different stages of development.

Let's take a look at some of the players in the peanut allergy therapeutics space.

1. Aimmune Therapeutics Inc. (AIMT)

Aimmune Therapeutics is a biopharmaceutical company developing treatments for life-threatening food allergies.

The Company's Biologics License Application for oral AR101 for peanut allergy is under FDA review, with a decision expected by January 2020. Before the FDA announces its decision, AR101 is likely to be reviewed by an advisory committee.

The Biologics License Application for AR101 was based on data from a phase III trial, dubbed PALISADE.

In the PALISADE trial, 499 patients of age 4-17, and 55 adult patients of age 18-49 were enrolled at more than 60 clinical sites in the United States, Canada, and eight countries in the European Union.

In the 4-17 age group, 496 of them received treatment. After approximately one year of treatment, patients completed an exit double-blind, placebo-controlled food challenge in which 67.2% of AR101-treated patients tolerated at least a 600-mg dose of peanut protein compared to 4.0% of placebo patients.

In the 18-49 age group, of the 41 patients in the AR101 arm, 21 patients discontinued treatment due to adverse events. In an exploratory analysis of this age group, 85% of AR101 patients who completed the study tolerated at least 600 mg of peanut protein in the exit double-blind, placebo-controlled food challenge compared to 15% of placebo patients who completed the study.

If approved, AR101 will be the first medicine for peanut allergy.

AIMT closed Thursday's trading at $21.94, down 1.57%.

2. DBV Technologies S.A. (DBVT)

DBV Technologies is a clinical-stage biopharmaceutical company developing a novel technology platform called Viaskin to address areas of unmet medical need, including in patients suffering from food allergies.

Viaskin is designed as a patch and is the first epicutaneous immunotherapy (EPIT) in development that leverages the skin to activate the immune system and induce desensitization in peanut-allergic children.

In a phase III study, dubbed PEPITES, Viaskin Peanut (250 Aµg) administered once-daily on the skin as a non-invasive patch demonstrated clinically meaningful desensitization in peanut-allergic children, suggesting patients who were treated with active therapy may be less likely to have an allergic reaction to an accidental exposure to peanut as compared to placebo. Viaskin Peanut was also observed to be well-tolerated in the trial, resulting in a low discontinuation rate due to treatment-emergent adverse events.

The Biologics License Application for Viaskin Peanut for the treatment of peanut allergy in children four to 11 years was submitted by DBV Technologies last October. Following correspondence with the FDA, the application had to be withdrawn last December as additional data on manufacturing procedures and quality controls were needed.

The Company is targeting resubmission of the Biologics License Application in the third quarter of 2019.

AIMT closed Thursday's trading at $9.04, down 0.55%.

3. AnaptysBio Inc. (ANAB)

AnaptysBio is a clinical-stage biotechnology company developing first-in-class antibody product candidates focused on unmet medical needs in inflammation.

The Company's lead product candidate for peanut allergy is Etokimab, previously known as ANB020, which has successfully completed a phase IIa trial.

In the phase IIa trial, six of 13 (46%) patients exhibiting moderate-to-severe symptoms during a baseline oral food challenge at enrollment improved peanut tolerance to cumulative 500mg at day 14 after a single dose of ANB020 compared to zero of three (0%) dosed with placebo.

However, the Company has decided not to utilize its clinical development resources to pursue a phase IIb trial of Etokimab in peanut allergy as a result of market assessment regarding the adoption of the peanut oral food challenge in future commercial usage of Etokimab in peanut allergy patients.

But that said, the Company may pursue potential investigator-sponsored trials of Etokimab in the indication of peanut allergy.

ANAB closed Thursday's trading at $80.01, up 0.05%.

4. Intrommune Therapeutics

New York-based Intrommune Therapeutics is a privately-held specialty biopharmaceutical company developing OMIT, a patient-friendly treatment platform, for peanut and other food allergies.

OMIT, or oral mucosal immunotherapy, enables regular administration of allergy immunotherapy in a fully functional toothpaste.

The Company's lead product candidate developed under the OMIT platform is INT301 for the treatment of peanut allergies. INT301 is expected to move into phase I study this year.

5. Camallergy

Cambridge, U.K.- based Camallergy (Cambridge Allergy Ltd) is a private biopharmaceutical company developing treatments for food allergies.

The Company's lead product candidate, CA002, is a novel oral immunotherapy for the treatment of peanut allergy.

In a phase II study, which involved 99 children with peanut allergy, aged 7 to 16 years, CA002 demonstrated safety and efficacy, and the Company is preparing to advance CA002 for the phase III registration trial.

6. Aravax

Melbourne, Australia-based Aravax is a clinical stage biotechnology company developing a precisely-targeted, next-generation treatment for peanut allergy.

The Company's lead product candidate is PVX108, a peptide-based immunotherapy designed to safely induce immune tolerance to peanut allergens.

PVX108 has successfully completed a phase I study in peanut-allergic adults in Australia, and the Company is working with the clinical community to design a phase II study of the compound.
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