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Posted by James Tannahill

On 05/16/19, RumorHound platform alerted a potential takeover of Aimmune Therapeutics (NasdaqGSM:AIMT; $20.20) where no potential acquirer was mentioned. AIMT is a clinical stage biopharmaceutical company that develops therapies focused on desensitizing patients suffering from food allergies.

 

The company’s CODIT (characterized oral desensitization immunotherapy) platform provides patients with a pharmaceutical-grade product along with patient/physician support to minimize the risks of exposure. Their lead program AR101 is a characterized oral immunotherapy (OIT) targeting peanut allergy and represents a standardized mixture of 13 naturally occurring peanut proteins that is administered orally QD. Based on PhII results, FDA granted Breakthrough Therapy Designation to AR101. AIMT initiated PALISADE, a pivotal PhIII development program in 1H16, which met its primary efficacy endpoint and presented data in 1H18 at AAAAI-WAO. The company plans to submit a BLA by year-end and begin a similar process in Europe, with the intention of filing a MAA with the EMA in 1H19. The company remains on track to report RAMSES and ARC004 data by year-end. RAMSES has been completed and data may be made available by the end of November. This is consistent with expectations for 2H19 approval of AR101. The European ARTEMIS study should read out data supportive of approval in 1H19. This data is likely to be consistent with the PhIII PALISADE study, given the broadly similar study design.


AIMT Demonstrated Robust Safety and Efficacy in PhIII trial. In the primary analysis of patients aged 4-17, the trial met its primary and secondary endpoints, and AR101 demonstrated an encouraging tolerability and safety profile over the course of one year of treatment. Treatment with AR101 produced statistically significant desensitization to peanut protein at month 12, where 76.6% of participants treated with AR101 tolerated 300 mg of peanut protein compared to 8.1% for placebo (p&lt;0.00001) and 67.2% tolerated 600 mg of peanut protein and 50.3% tolerated 1000 mg of peanut protein- well above placebo's 4.0% and 2.4%, respectively (both highly statistically significant). The prespecified success criterion was 15% and notably, participants could tolerate no more than 30 mg of peanut protein at study entry.


AIMT Strongly Demonstrated Safety and Efficacy in PhII trial. In PhII development, patients were incrementally dosed with AR101 over 20-22 weeks starting at an initial 0.5mg dose + exiting at 300mg. Results unequivocally demonstrated efficacy suggesting 79% of AR101 patients tolerated the 300mg dose of peanut protein or a cumulative dose of 443mg. Such results compare to a responder rate of nearly 19% of patients comprising a placebo arm; where AR101 so afforded subjects who present a peanut allergy significant protection from accidental exposure to peanuts. Such a safety profile was accepted where mild and transient gastrointestinal (GI) side effects were reported and these symptoms were resolved in 1-2 weeks upon discontinuation of said regimen. Importantly, observed GI adverse effects were expected given such a route of administration and those were consistent with literature reports of oral desensitization treatments of this type of therapeutic.


AR201 and AR301 Development Programs AIMT is advancing the development of two other candidates, AR201 and AR301, targeting egg allergy and walnut allergy, respectively. Both programs are expected to progress to PhII development in 2H19 and AIMT plans to file an NDA for ‘301 in 2019.


1Q19 Earnings Call Notes:

  1. Lancet article published recently cast oral immunotherapy for peanut allergy in
    a negative light.  The conclusions drawn by the authors were out of context
    and shortsighted.  This, however, has certainly put recent downward pressure on the
    share price.
  2. There will be new data share at the EAACI conference in Portugal in early June.  This
    includes: the data from the ARTEMIS trial, data regarding the longest therapy times we
    have seen to date from the ARCO4 rollover study, and additional quality of life data. This
    should all be positive for the company.
  3. AIMT has held dialogs with ~70% of the payers responsible for patient coverage
    (covering 33% of target patients), and those conversations are going well.  Hoping to
    meet with 80% payers before anticipated approval in late Jan.
  4. The ICER report on OIT peanut therapy costs relative to benefits has not been a major
    factor in AIMT&#39;s discussions with payers about the cost of the drug.
  5. A date has not been set for the advisory committee meeting concerning the BLA
    approval of AR101, timing guidance still expected 2H19.
  6. Marketing and sales force at the company has doing an excellent job precisely
    identifying and prepping the physicians and clinics that will be the initial commercial
    targets (~200-300 clinics/allergists to early adopt out of the gate, increasing to ~700
    clinics and 1300 allergists thereafter, which represents 70% of patients&#39; providers,
    moving to more complete market penetration thereafter, 5000 practicing allergists in US
    in total)
  7. Manufactures and clinics have been contacted by FDA so AR101 BLA submission is
    certainly actively being reviewed
  8. The hypothesis holds that in the ~3-5 years of therapy timeframe some subpopulation of
    patients will go into true remission of their peanut allergy, but conclusive data not
    available yet.
  9. Specific pricing guidance not provided yet


Key Upcoming Dates

  1. Early June -- June 2nd oral presentation at EAACI regarding ARTEMIS data, and 2-3
    other poster presentations at the conference
  2. June 11--Public hearing on ICER report (final draft presented then?)
  3. "Mid 2019"--AR201 PhII trial to commence
  4. "Mid 2019"--MAA submitted to EU for AR101 approval (German, France, UK to be
    initial markets, Germany first)
  5. 2H 2019--FDA Ad Com meeting anticipated (no date yet)
  6. Jan 2020--FDA approval of AR101 (could be earlier)
  7. Mid 2020--EU approval of AR101
  8.  

About Aimmune

Aimmune Therapeutics, Inc., is a biopharmaceutical company developing oral treatments for life-threatening food allergies. The company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens. Aimmune’s first, investigational, complex biologic product, AR101, is being developed as a treatment to reduce the frequency and severity and adverse events following exposure to peanut. The BLA for AR101 is under review by the FDA, which granted AR101 Breakthrough Therapy Designation in 2015 for the desensitization of peanut-allergic patients 4 to 17 years of age. The Allergenic Products Advisory Committee (APAC) of the FDA will review the BLA for AR101 at a meeting scheduled for September 13, 2019. Aimmune has filed an IND application for its second product, AR201 for the treatment of egg allergy, and intends to start a randomized phase 2 clinical trial in mid-2019. For more information, please see www.aimmune.com.


Topics: Rumor Hound