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Expert Interview

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Another Expert Opinion: Following Phase 3 Study Initiation of Viaskin in Peanut Allergy, We Discuss the Data Released To Date

Ticker(s): DBVT, AIMT

Who's the expert?

Name: Dr David M Fleischer - MD

Institution: University of Colorado Medicine

  • Associate Section Head of the Section of Allergy at Children’s Hospital Colorado (CHCO), Co-Director of the Food Challenge and Research Unit, and an Associate Professor of Pediatrics at CHCO and the University of Colorado Denver School of Medicine.
  • Global PI for the pivotal Phase III peanut epicutaneous immunotherapy trial being conducted at more than 30 sites across the world. Member of the National Institutes for Allergy and Infectious Diseases (NIAID) Expert Panel that updated the 2010 NIAID Food Allergy Guidelines on the topic of the Prevention of Peanut Allergy.
  • Research has focused on the natural history of food allergy and novel treatments for food allergy, including oral, sublingual, and epicutaneous immunotherapies.

Interview Questions
Q1.

Please describe your clinical background current treatment of patients with Peanut Allergies.

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Q2.

Please describe the patient population demographics with Peanut Allergy, their ages, and approximately how many have the  Type 1,  IgE mediated, immediate hypersensitivity reaction, and how many have the delayed and dose dependent response Types 3 and 4?

  • Would Viaskin or AR101 be more suitable in treating one type of allergy than the other?

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Q3.

Would Viaskin or AR101 work well regardless of the age at which it is introduced to the patient? Are they more effective taken early on, as a child? Does the immune system still adapt to not see peanut protein as a trigger for response in older patients? (AR101 has older patients enrolled in the PALISADE study too, although the majority, 57% of the patients enrolled are between 4-11 years of age)

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Q4.

Viaskin and AR101 are, at the core, ways to decrease the sensitivity of patients to peanut exposure. In what other ways can a patient achieve that? Are the alternatives more expensive or effective?

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Q5.

What is the difference between Viaskin, AR101, and basic peanut protein, besides the fact that the drugs have exact measured concentrations, tested dosages, and a good delivery method, through the skin(Viaskin) and orally(AR101). In what way are the main compounds different, and through what mechanism of action do they decrease patient sensitivity to peanut?

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Q6.

In urgent care settings, what is the first-line of treatment used for treating Peanut Allergy reactions and to stabilize the patient? And what has been the standard of care for long-term desensitization until now?

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Q7.

In a data presentation released March 2017 from VIPES study in children 6-11 years, DBVT reported that treatment with VP 250 μg showed CRD increase to 1440 mg at month 36, from 44 mg at the start. What is the clinical relevance of going from 44 to 1440 on CRD? How would it translate into the lifestyle changes of the patient?

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Q8.

In the Phase 3 PALISADE trial of AR101, 62% of the patients were reactors and 38% were non-reactors, up to the 100-mg dose.    Can you discuss the data points on the immune parameters presented, Peanut SPT Peanut-Specific IgE and Ara h 2 IgE.

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Q9.

Another Viaskin data presentation in March cites Peanut-allergic individuals decreased their risk of an allergic reaction 67- to 5089-fold for all of the diverse products containing peanut, following treatment.  How does this data compare to long-term desensitization treatments you’ve previously used? Is the risk decrease substantial, in your opinion?

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Q10.

Please discuss how you believe patients and their families will weigh efficacy vs. safety vs. ease of use when considering whether to try new peanut-allergy treatments.

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Q11.

Private practitioners of OIT and past OIT trials have used commercially available peanut protein to desensitize patients. Will the availability of this cheap option impact the success of either Viaskin or Aimmune's AR101?

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Q12.

With parents, less risky adverse events such as skin rash may have an outsized impact on commercial viability.   Have you had/heard any feedback on skin rash around the Viaskin patch site, the level of discomfort to the child, the ability to maintain consistent dose (i.e. keep the patch on), the willingness to keeping trying in hopes of improving tolerance over time, etc.?  How important a factor is patch site skin rash to the potential success of the product?

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Q13.

Have you had/heard feedback on how practical Viaskin patch is?  How compatible is it with the daily routine of active children?  Are there issues keeping the patch in place and viable while swimming, sweating while running around, bathing etc.?

Added By: c_admin
Q14.

How well can the two products be compared due to differences in their trial eligibility criteria? For example: DBV REALISE trial, Ages 4-11, psIgE ≥14 kU/L Aimmune ARTEMIS trial, Ages 4 -17 Years, psIgE ≥ 0.35 kUa/L

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Q15.

Do you know what the source is for the peanut material used in the Viaskin patch?

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Q16.

How does the change in patient population (enrolling more allergic and younger patients) from VIPES to PEPITES enhance or diminish the likely chance of success? 

Added By: user2323
Q17.

How does the change in the primary endpoint from VIPES (phase II) to PEPITES (phase III) enhance or diminish the likelihood of success for the study?  What sort of delta between placebo and those on drug in terms of responders would you consider this trial a success?  Is there a delta between placebo and drug for which you would find disappointing despite the study hitting its primary endpoint?

Added By: user2323

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