POISED Study Supports Risk of Cessation of Oral Immunotherapy for Peanut Allergy; PACE Study Indicates Safer Peanut Allergy Treatment Approaches are Needed

New York, Nov. 07, 2019 (GLOBE NEWSWIRE) -- A major study recently published in The Lancet, “Sustained outcomes in oral immunotherapy for peanut allergy (POISED study),” further validates the benefit of oral immunotherapy (OIT) for peanut allergy treatment and highlights the potential risks of allergy immunotherapy discontinuation.    

“The POISED study validates the strategy behind INT301, our lead oral mucosal immunotherapy (OMIT) treatment product for peanut allergy,” said Michael Nelson, CEO, Intrommune. “These data further prove that success with allergy immunotherapy hinges on consistent exposure of a patient’s immune system to gradually “desensitize” the patient to the specific allergy trigger over time.” Brushing with INT301, a specialized, fully functional toothpaste whose ingredients include peanut allergens in therapeutic doses, removes the onus of daily dosing and thus avoids “medication fatigue” which has proven an obstacle to long-term maintenance. 

The POISED study involved 120 participants, of whom 95 received escalating doses of peanut protein up to 4000 mg up to week 104, then separated randomly into groups that ingested 300 mg peanut protein daily for 52 weeks, or received oat flour (placebo group). Consistent with clinical observations in numerous preceding OIT investigational studies, subjects enrolled in POISED experienced gastric distress and other adverse reactions. Double blind, placebo-controlled food challenges (DBPCFCs) to 4000 mg peanut protein were done at baseline and periodically through week 156. The authors concluded “that peanut OIT could desensitize individuals with peanut allergy to 4000 mg peanut protein but discontinuation, or even reduction to 300 mg daily, could increase the likelihood of regaining clinical reactivity to peanut.” All study participants were enrolled in the research at the Sean N Parker Center for Allergy and Asthma Research at Stanford University (Stanford, CA, USA). 

“The Stanford results address the concern that has shadowed OIT from the beginning, that discontinuing treatment or half-hearted maintenance can undo the gains and leave a person even more vulnerable,” said William Reisacher, MD, an Otolaryngologist who specializes in Allergy at Weill Cornell Medicine/NewYork-Presbyterian Hospital. “Daily handfuls of peanut M&Ms may sound like a treat, but when taken as medicine, people will get tired of that. Plus, peanut allergic individuals often develop a protective psychological aversion to the taste and smell of peanuts. On the other hand, taste and flavor can be masked by a toothpaste and regular tooth brushing is a near universally accepted daily routine.”

Other limitations of OIT were underscored in a meta-analysis by Chu, et al., titled “Oral immunotherapy for peanut allergy (PACE): a systematic review and meta-analysis of efficacy and safety” also published in The Lancet. Their multinational literature review concluded, “In patients with peanut allergy, high-certainty evidence shows that available peanut oral immunotherapy regimens considerably increase allergic and anaphylactic reactions over avoidance or placebo, despite effectively inducing desensitization. Safer peanut allergy treatment approaches and rigorous randomized controlled trials that evaluate patient-important outcomes are needed.” Dr. Reisacher comments, “We believe that oral mucosal immunotherapy, by avoiding the gastric tract, will reduce the incidence of systemic adverse reactions while still engaging the immune system in the direction of desensitization.”

About Peanut and Other Food Allergies
Food allergies affect an estimated 220 million people, including more than 9 million adults and 6 million children in the U.S. Management of food allergies currently focuses on avoidance of exposure to triggering foods, though many such foods such as peanuts are common ingredients in food products and therefore difficult to avoid. Many people with peanut allergy are accidentally exposed and experience potentially life-threatening reactions, including anaphylaxis, each year. Unfortunately, there are no FDA-approved therapies for any food allergy, an area of tremendous unmet medical need.

About Oral Mucosal Immunotherapy
Oral mucosal immunotherapy (OMIT) uses a specially formulated toothpaste to stabilize and deliver allergenic proteins to immunologically active areas of the oral cavity with the greatest potential for allergy desensitization. Success with allergy immunotherapy hinges on 
consistent exposure of a patient’s immune system to gradually “desensitize” the patient to the specific allergy trigger over time. OMIT promises advantages over other approaches to allergy immunotherapy due to its targeted delivery, simplified administration, and support of 
reliable, long-term adherence.

About Intrommune Therapeutics
Intrommune, dedicated to improving and protecting the lives of people with food allergy, is developing the revolutionary oral mucosal immunotherapy (OMIT) treatment platform for food allergies. OMIT is a long-term, patient-friendly, disease-modifying solution for the 220 million people, including more than 9 million adults and 6 million children in the U.S., who suffer from life-altering food allergies. Intrommune’s lead product, INT301, is expected to be a safe, effective and convenient therapy for patients who suffer from peanut allergy. 

The Keiretsu Forum, a global investment community of accredited angel investors, has engaged in a thorough diligence process with Intrommune and has issued a positive report. To access this report, please visit: http://www.intrommune.com/keiretsu-dd

For more information on Intrommune Therapeutics, please visit http://www.intrommune.com

Sustained outcomes in oral immunotherapy for peanut allergy (POISED study): a large, randomised, double-blind, placebo-controlled, phase 2 study, R.S. Chinthrajah, et al. Sept 12, 2019. Lancet;394(10207):1437-1449. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)31793-3/fulltext

Oral immunotherapy for peanut allergy (PACE): a systematic review and meta-analysis of efficacy and safety, Chu DK, et al. Jun 1, 2019. Lancet;393(10187):2222-2232. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)30420-9/fulltext 

Cautionary Statement Regarding Forward Looking Statements
This release may contain "forward-looking statements." Forward-looking statements are identified by certain words or phrases such as "may," "will," "aim," "will likely result," "believe," "expect," "will continue," "anticipate," "estimate," "intend," "plan," "contemplate," "seek to," "future," "objective," "goal," "project," "should," "will pursue" and similar expressions or variations of such expressions. These forward looking statements reflect the company's current expectations about its future plans and performance. These forward-looking statements rely on a number of assumptions and estimates which could be inaccurate and which are subject to risks and uncertainties. Actual results could vary materially from those anticipated or expressed in any forward-looking statement made by the company. The company disclaims any obligation or intent to update the forward-looking statements in order to reflect events or circumstances after the date of this release. This release does not contain or constitute an offer to sell or a solicitation of any offer to buy securities in the United States or in any other jurisdiction.


Contact Data