Allergies, Author Interviews / 20.07.2020

MedicalResearch.com Interview with: [caption id="attachment_51005" align="alignleft" width="159"]Todd Green MD Vice President of Medical Affairs North America DBV Technologies Dr. Green[/caption] Dr. Todd Green Vice President of Clinical Development and Medical Affairs https://www.dbv-technologies.com MedicalResearch.com: What is the background for this study? Response: The PEOPLE study is an open-label extension of the Phase III PEPITES trial designed to evaluate the long-term safety, tolerability and efficacy of Viaskin Peanut 250 μg (DBV712). Participants who completed the 12-month study period of PEPITES were eligible to enroll in PEOPLE, which evaluates the eliciting dose (ED) after three years (Month 36) of active treatment using a double-blind, placebo-controlled food challenge (DBPCFC). 
Allergies, Author Interviews / 22.01.2020

MedicalResearch.com Interview with: [caption id="attachment_52925" align="alignleft" width="133"]Dr. Dianne Campbell, MBBS, FRACP, PhD VP, Global Medical Affairs DBV Technologies   Dr. Campbell[/caption] Dr. Dianne Campbell, MBBS, FRACP, PhD VP, Global Medical Affairs DBV Technologies   MedicalResearch.com: What is the background for this study? Response: The PEOPLE study is an open-label extension of the Phase III PEPITES trial designed to evaluate the long-term safety, tolerability and efficacy of Viaskin Peanut 250 μg (NCT03013517) in peanut-allergic children ages 4 to 11 years . Participants who completed the 12-month study period of PEPITES were eligible to enroll in PEOPLE. Patients who were randomized to active treatment in PEPITES are eligible to receive up to four additional years of treatment, and those previously receiving placebo are eligible to receive up to five years of treatment. The current study reports on the 3 year outcomes of children who were initially randomized to receive active treatment in the PEPITES study and completed an additional 2 years of treatment during the PEOPLE study. The study evaluated the eliciting dose (ED) after three years (Month 36) of active treatment using a double-blind, placebo-controlled food challenge (DBPCFC). The starting dose of each challenge was 1 mg of peanut protein and escalated to the highest dose of 2,000 mg peanut protein; possibly repeated once to reach a maximum total cumulative dose of 5,444 mg peanut protein. All participants who reached an ED ≥ 1,000 mg at Month 36 were eligible to continue the study for two additional months without treatment while maintaining a peanut-free diet. A further double-blind placebo-controlled food challenge to determine ED was administered at the end of this period (Month 38). Additional analyses include exploratory assessments of safety parameters, immune biomarkers such as immunoglobulin G4 (IgG4) and immunoglobulin E (IgE).
Allergies, Author Interviews / 06.09.2019

MedicalResearch.com Interview with: [caption id="attachment_51129" align="alignleft" width="133"]Edwin H. Kim, MD, MS Assistant Professor of Medicine & Pediatrics, Division of Rheumatology, Allergy & Immunology Program Director, UNC Allergy and Immunology Fellowship Program Director, UNC Food Allergy Initiative Medical Director, UNC Allergy & Immunology Clinic UNC School of Medicine Chapel Hill, NC Dr. Edwin H. Kim[/caption] Edwin H. Kim, MD, MS Assistant Professor of Medicine & Pediatrics, Division of Rheumatology Allergy & Immunology Program Director, UNC Allergy and Immunology Fellowship Program Director, UNC Food Allergy Initiative Medical Director, UNC Allergy & Immunology Clinic UNC School of Medicine Chapel Hill, NC MedicalResearch.com: What is the background for this study? Response: In 2011, Kim and colleagues – including Wesley Burks, MD, dean of the UNC School of Medicine – conducted a small study of 18 patients to show that sublingual immunotherapy (SLIT) was safe and effective over the course of one year. Since then, Kim and colleagues followed 48 patients in the SLIT protocol of 2 mg daily for five years. In the JACI paper, the researchers showed that 67 percent of these patients were able to tolerate at least 750 mg of peanut protein without serious side effects. About 25 percent could tolerate 5000 mg
Allergies, Author Interviews, Pediatrics, Pharmaceutical Companies / 21.08.2019

MedicalResearch.com Interview with: [caption id="attachment_51005" align="alignleft" width="159"]Todd Green MD Vice President of Medical Affairs North America DBV Technologies Dr. Todd Green[/caption] Todd Green MD Vice President of Medical Affairs North America DBV Technologies https://www.dbv-technologies.com   Dr. Green discusses the recent announcement that DBV Technologies is submitting a BLA for Viaskin Peanut to the FDA.   MedicalResearch.com: What is the background for this announcement? How common is peanut allergy in children?  DBV Technologies is a global clinical-stage biopharmaceutical company whose mission is to improve the lives of patients with food allergies and other immunological diseases through our investigational epicutaneous immunotherapy technology platform. For more than 15 years, we’ve been striving to deliver transformative treatments for patients suffering with the burden and life-threatening risk of food allergies. On August 7, 2019 DBV announced the submission of its Biologics License Application (BLA) to the U.S. Food and Drug Administration for Viaskin® Peanut for the treatment of peanut-allergic children ages 4 to 11 years. This submission addressed the additional data needed on manufacturing procedures and quality controls which were communicated by the FDA in December 2018, when DBV voluntarily withdrew its prior BLA submission for Viaskin Peanut. Peanut allergy is one of the most common food allergies and can cause severe, potentially fatal allergic reactions, including anaphylaxis. In the United States, nearly one million children suffer from a peanut allergy.[1] Fear of life-threatening reactions triggered by accidental peanut exposure during everyday activities may lead to significantly increased anxiety and decreased quality of life for patients and their families.[2,3,4] Currently, avoidance and readiness to manage accidental exposure reactions remain the standard of care. At DBV, we are committed to finding treatments that will help address the urgent unmet medical need of those suffering from food allergies, including peanut allergy, and our mission is to improve the lives of those patients and their families.
Allergies, Author Interviews, Immunotherapy, JAMA / 06.05.2019

MedicalResearch.com Interview with: [caption id="attachment_48976" align="alignleft" width="129"]Dr. Marcus Shaker Dr. Shaker[/caption] Marcus S. Shaker, MD Associate Professor of Pediatrics Associate Professor of Community and Family Medicine Dartmouth-Hitchcock Medical Center MedicalResearch.com: What is the background for this study? Response: There are two peanut allergy treatments that are being evaluated for potential FDA approval—an orally administered treatment and an epicutaneous (skin based) treatment.  Both have tremendous potential benefit.  The focus of our study was to explore the range of health and economic benefits in terms of establishing pathways for how each therapy could be cost effective. We want to be clear that our purpose was not to suggest one therapy is or is not cost effective at present.  That would be a ridiculous statement to make regarding two treatments that not only lack FDA approval, but do not have established pricing.  Rather, we used preliminary inputs that are presently available to create as robust a model as we could to better determine the individual paths that would make them more or less cost-effective.
Allergies, Author Interviews, Immunotherapy, Pediatrics / 18.04.2019

MedicalResearch.com Interview with: [caption id="attachment_48695" align="alignleft" width="162"]Lianne Soller, PhDAllergy Research ManagerUniversity of British ColumbiaVancouver, BC, Canada   Dr. Soller[/caption] Lianne Soller, PhD Allergy Research Manager University of British Columbia Vancouver, BC, Canada   MedicalResearch.com: What is the background for this study? What are the main findings? Response: In 2017, a clinical trial of 37 subjects demonstrated that preschool peanut oral immunotherapy was safe, with predominantly mild symptoms reported and only one moderate reaction requiring epinephrine. Our study aimed to examine whether these findings would be applicable in a real-world setting (i.e., outside of research). We found that peanut oral immunotherapy is safe in the vast majority of preschoolers, with only 0.4% of patients experiencing a severe reaction, and only 12 out of ~40,000 peanut doses needed epinephrine (0.03%). 
Allergies, Author Interviews, Pediatrics / 04.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47726" align="alignleft" width="200"]Todd Green MD Vice President, Medical Affairs North AmericaDBV TechnologiesAssociate Professor of PediatricsUniversity of Pittsburgh School of Medicine Dr. Green[/caption] Todd Green MD  Vice President, Medical Affairs North America DBV Technologies Associate Professor of Pediatrics University of Pittsburgh School of Medicine MedicalResearch.com: What is the background for this announcement? What is Viaskin Peanut? Response: Peanut allergy is one of the most common food allergies and can cause severe, potentially life-threatening allergic reactions, including anaphylaxis. Unfortunately, there are no FDA-approved treatment options for peanut or other food allergies – leaving patients with avoidance and readiness to manage reactions to accidental exposures as their only option. Viaskin Peanut uses epicutaneous immunotherapy or EPIT, a method of delivering biologically active compounds to the immune system through the skin. Patients receive about 1/1,000th of a peanut with each daily dose of peanut protein – the equivalent of one peanut every three years – which activates the immune system with very minimal exposure. In February 2019, DBV announced that its planned resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for Viaskin Peanut in the treatment of peanut-allergic children 4 to 11 years of age is anticipated in the third quarter of 2019. DBV is working diligently on its resubmission package, bringing us one step closer to providing an FDA-approved treatment for peanut-allergic children and their families. Viaskin Peanut previously received Breakthrough and Fast Track designations for the treatment of peanut-allergic children from the FDA in 2015 and 2012, respectively. 
Allergies, Author Interviews, Immunotherapy, JAMA, Pediatrics / 01.03.2019

MedicalResearch.com Interview with: [caption id="attachment_47721" align="alignleft" width="200"]Dr. Matthew GreenhawtDirector, Food Challenge and Research UnitChildren’s Hospital Colorado Dr. Greenhawt[/caption] Dr. Matthew Greenhawt Director, Food Challenge and Research Unit Children’s Hospital Colorado MedicalResearch.com: What is the background for this study? Response: In the US, nearly one million children suffer from a peanut allergy and severe reactions to food allergens are not uncommon – yet there is significant unmet need in the food allergy immunotherapy space, as there are no currently approved treatment options. That being said, we are encouraged by the efficacy and safety data, which support Viaskin Peanut as a convenient and well-tolerated potential treatment option for the peanut allergy. In the pivotal Phase III clinical trial (PEPITES) just published in The Journal of the American Medical Association (JAMA), Viaskin Peanut – the first epicutaneous immunotherapy (EPIT) in development that leverages the skin to activate the immune system – provided statistically significant desensitization in peanut-allergic children ages 4-11 years old. Patients who were treated with active therapy were more likely to have increased their eliciting dose to peanut (the amount of peanut protein ingested before an objective allergic reaction was seen during a double-blind, placebo-controlled food challenge) by a required amount as compared to patients treated with a placebo patch. The improvement suggests a reduced risk of allergic reaction to accidental peanut ingestion in the group treated with Viaskin Peanut, with no change seen in the placebo group.
Allergies, Author Interviews, Immunotherapy / 25.02.2019

MedicalResearch.com Interview with: Dr Paul Turner FRACP PhD MRC Clinician Scientist and Clinical Senior Lecturer, Imperial College London Honorary Consultant in Paediatric Allergy & Immunology Imperial College Healthcare NHS Trust Hon Consultant, Royal Free Hospital / Royal Brompton & Harefield NHS Foundation Trust Clinical trials specialist (Paediatrics), Public Health England Clinical Associate Professor in Paediatrics, University of Sydney, Australia Dr. Nandinee Patel, MD Section of Paediatrics Imperial College London London, United Kingdom MRC & Asthma UK Centre in Allergic Mechanisms of Asthma London, United Kingdom MedicalResearch.com: What is the background for this study? Response: Current desensitisation protocols for peanut allergy use defatted roasted peanut flour, which can be difficult to accurately measure in very low doses needed for desensitisation (and thus has resulted in the development of AR101 by Aimmune which is likely cost many thousands of dollars for a course of treatment). We have previously observed that some children with food allergy to roasted peanut (such as peanut butter) are nonetheless able to tolerate boiled peanuts without reacting. We performed in vitro protein analysis studies which demonstrated that boiling peanuts resulted in around 50% of protein leaching out of the peanut into the cooking water. Furthermore, we found evidence for preferential leaching of allergen epitopes such as Ara h 2 as well aggregation of proteins resulting in a hypoallergenic peanut product. We therefore sought to assess whether boiled peanuts could be as effective and safe to induce desensitisation.
Allergies, Author Interviews, NIH, Pediatrics / 05.01.2017

MedicalResearch.com Interview with: [caption id="attachment_30951" align="alignleft" width="130"]Anna Nowak-Wegrzyn, MD Associate Professor of Pediatrics Icahn School of Medicine at Mount Sinai Jaffe Food Allergy Institute New York, NY 10029 Dr. Anna Nowak-Wegrzyn[/caption] Anna Nowak-Wegrzyn, MD Associate Professor of Pediatrics Icahn School of Medicine at Mount Sinai Jaffe Food Allergy Institute New York, NY 10029 MedicalResearch.com: What is the background for this study? Response: Peanut allergy can be fatal, is usually life-long and has no cure. Considering a dramatic increase in prevalence of peanut allergy over the past decades, affecting estimated 2-3% of infants and young children in the US, there is a dire need for prevention. Prior studies determined that risk of peanut allergy is highest in the infants with severe eczema, those with mutations in filaggrin gene resulting in an impaired skin barrier function and those not eating peanut but exposed to peanut in the household dust. In addition, the prevalence of peanut allergy was 10-fold higher among Jewish children in the United Kingdom compared with Israeli children of similar ancestry. In Israel, peanut-containing foods are usually introduced in the diet when infants are approximately 7 months of age and consumed in substantial amounts, whereas in the United Kingdom children do not typically consume any peanut-containing foods during their first year of life. Based on these observations, a landmark clinical trial (Learning Early about Peanut Allergy, LEAP) has been designed to evaluate whether early introduction of peanut into the diet of infant considered at high risk for peanut allergy can reduce the risk of peanut allergy compared to avoidance of peanut. LEAP and other studies suggested that peanut allergy can be prevented by introduction of peanut-containing foods in infancy. The overall reduction in peanut allergy among the infants in the LEAP trial randomized to an early introduction group compared to those who avoided peanut until age 5 years was 81%.
Allergies, Author Interviews / 01.08.2014

Supinda Bunyavanich, MD, MPH, MPhil Department of Pediatrics- Allergy/Immunology Department of Genetics and Genomic Sciences Icahn Institute for Genomics and Multiscale Biology Mindich Child Health and Development Institute Icahn School of Medicine at Mount Sinai New York, NY 10029 USAMedicalResearch.com Interview with: Supinda Bunyavanich, MD, MPH, MPhil Department of Pediatrics- Allergy/Immunology Department of Genetics and Genomic Sciences Icahn Institute for Genomics and Multiscale Biology Mindich Child Health and Development Institute Icahn School of Medicine at Mount Sinai New York, NY 10029 USA Medical Research: What are the main findings of the study? Dr. Bunyavanich: What is the prevalence of peanut allergy among US children? Given that 90% of US households consume peanut butter, this is an important question. We report and compare prevalence estimates of childhood peanut allergy according to varying criteria among 7-10 year-old children participating in a US birth cohort not selected for any disease. The prevalence of peanut allergy ranged from 2.0% to 5.0%, depending on definition.