Earlier this month, FARE staff members attended the annual scientific meeting of the American Academy of Allergy, Asthma & Immunology, where researchers presented a number of new abstracts. Of interest to the food allergy community, both Aimmune Therapeutics and DBV Technologies presented new findings during the session for late-breaking abstracts.
Aimmune reported data from ARC002, an open-label Phase 2 trial of AR101, a peanut allergen formulation for oral immunotherapy use in the treatment of peanut allergy. In this trial involving participants ages 4-21, former placebo subjects up-dosed to 300 mg of peanut protein over a period of 22 weeks and then underwent double-blind placebo-controlled food challenge after two more weeks of therapy. In this group, 20 of 26 of the placebo subjects passed the challenge at 443 mg of peanut and entered the open-label continuation trial, during which they received 12 weeks of treatment with AR101.
In the group that had previously undergone therapy with AR101, 21 out of 29 participants also entered the open-label continuation trial. Researchers reported that 100 percent of participants in both groups tolerated 443 mg of peanut protein, 90 percent tolerated 1,043 mg of peanut protein and 60 percent tolerated 2,043 mg of peanut protein. The highest amount is equivalent to about seven or eight peanuts. Two participants required single doses of epinephrine during the double-blind placebo-controlled food challenge. None required epinephrine during the double-blind placebo-controlled food challenge that followed up-dosing. Five patients stopped the trial, primarily due to gastrointestinal side effects.
According to a press release from Aimmune, the ARC002 results showed increasingly good tolerability of AR101 with continued treatment. The press release also stated, “As many as a third of patients who began up-dosing in ARC002 (placebo crossovers) experienced an adverse event on the initial dosing day, which consists of up to five gradually escalating doses. During the biweekly up-dosing period, ARC002 patients as a whole (placebo crossovers and active rollovers) experienced on average an adverse event approximately once a month. During daily maintenance therapy, the rate decreased to about once every two to three months.”
Results from the open label phase of this trial indicate that AR101 is safe and effective, according to Aimmune.
“These data suggest that treatment with AR101 could provide effective protection against accidental ingestion for the majority of peanut allergic individuals,” said J. Andrew Bird, MD, assistant professor at the University of Texas Southwestern Medical Center. “Accidental exposures to peanut typically involve ingestion of less than one peanut and often just traces of peanut, and we have shown that the levels of desensitization achieved in the post-therapy food challenges after 12 weeks of low-dose maintenance in ARC002 protect against ingestion of more than one peanut for 85 percent of participants in the study. It is particularly encouraging to see that, over time, this treatment was well-tolerated by the majority of participants, as immunotherapy must be sustained to continue to be effective.”
Favorable safety and efficacy data was also reported by DBV Technologies regarding OLFUS-VIPES, the ongoing, open label, two-year follow-up study of VIPES, the Phase IIb clinical trial of Viaskin® Peanut, also known as the peanut patch.
Out of 207 participants who completed the VIPES randomized controlled trial, 171 entered the open label continuation. These participants had previously received either placebo or one of three 12-month dose regimens.
Hugh A. Sampson, primary investigator of the OLFUS-VIPES study, director of the Jaffe Food Allergy Institute at the Kravis Children’s Hospital at Mount Sinai and chief scientific officer for DBV Technologies, reported that 80 percent of children ages 6 to 11 responded to Viaskin Peanut 250 µg in the trial. Two years into the trial, the average cumulative reactive dose among this group was 1,883 mg of peanut protein compared with 84 mg at baseline. (One peanut contains approximately 250 mg of peanut protein.)
According to a press release from DBV Technologies about this research, a doubling in response rates at 1,000 mg or more during the oral food challenge was observed during the second year of treatment in children dosed with Viaskin Peanut 250 µg, which increased to 60 percent.
“Data from OLFUS-VIPES support an increase in treatment response over time. Patients were highly motivated and we saw excellent treatment compliance and no treatment-related dropouts,” Sampson said in a press release. “I believe this is a unique feature of Viaskin Peanut, which continues to show a strong safety profile. We also continue to observe a significant increase in the level of peanut protein consumed by patients that have been treated for two years.”
There were no reactions that required epinephrine, nor were any treatment-related serious adverse events observed during the trial. Most adverse events were considered to be mild or moderate, mainly related to skin symptoms. Those events were less frequent as the trial continued.
The study’s authors also reported that compliance to the trial’s protocol was very high – more than 96 percent across trial sites.
Viaskin was also observed to maintain response rates in adolescents and adults over time. Based on these results, DBV intends to explore additional Viaskin Peanut dose regimens in populations not included in the ongoing Phase III trial, which is studying Viaskin Peanut in children four to 11 years of age.
Learn more about this study, as well as other abstracts involving Viaskin Peanut and Viaskin Milk, in a press release from DBV Technologies. For information on how to get involved with a DBV clinical trial, visit this link at clinicaltrials.gov.