While waiting for Mueller’s report we stopped speculating on the stocks in what we saw as an unreadable market. Following the delivery of the Mueller report we hesitated to prophesy as we waited to see how the market would perform and the reasons for its performance. We usually try to speculate about the performance of biotech firms’ stocks based on their scientific capabilities, including their technologies’ and products’ promises; with many other considerations related to biotechnology. The biotech stocks’ performances; however, like all other stocks, do not depend entirely on the firms’ accomplishments. The biopharma stocks can either reach the moon or get entombed, based on the market’s moves, which depend on the status of the economy and many other factors, including the degree of the country’s appropriate relations between politicians.
The market seemed happy yesterday and even happier today which makes us tilt to the optimistic rather than pessimistic. We have a lot of news regarding gene editing and gene therapy,novel liquid diagnostic procedures and novel treatments, etc., which we will start to post on the Prohost website.
Today, we start by confirming some good news for children who cannot eat peanuts due to their allergy. A European trial data confirmed the successful results of a previous American trial aimed at treating peanut allergy.
In the NEWS
From Aimmune Therapeutics (AIMT) we learned that its phase 3 European clinical trial ARTEMIS, of its product AR101, for the treatment of peanut allergy, has met its primary efficacy endpoint. Top-line data show that the proportion of AR101-treated patients, who tolerated a 1,000-mg dose of peanut protein in a blinded exit challenge after approximately nine months of AR101 treatment, was significantly higher than in the placebo group.
AR101-treated patients improved 100-fold from 10 mg at baseline to 1,000 mg at exit.
The safety profile and completion rate observed in ARTEMIS are consistent with the results seen in previous AR101 clinical trials. No cases of anaphylaxis or of eosinophilic esophagitis (EoE) were observed.
Aimmune plans to present full results in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress in early June.
Phase 3 ARTEMIS trial, AR101 and Peanut Allergy
The randomized, double-blind, placebo-controlled phase 3 ARTEMIS clinical trial enrolled 175 children and adolescents ages 4 to 17 from 18 sites in: Italy, France, Spain, Germany, Ireland, Sweden and the United Kingdom. The patients underwent approximately six months of dose escalation and then three months at a daily therapeutic dose of AR101 at 300 mg or placebo followed by an exit, double-blind, placebo-controlled food challenge. The primary efficacy endpoint was patients’ ability to tolerate a 1,000-mg single dose of peanut protein, the equivalent of approximately three to four peanut kernels (2,043 mg cumulative; equivalent to seven or eight peanut kernels).
Based on these positive results Aimmune intends to submit a Marketing Authorization Application (MAA) for AR101 to the European Medicines Agency (EMA) in mid-2019. Aimmune submitted a Biologics License Application (BLA) for AR101 to the U.S. Food and Drug Administration (FDA) in December 2018. Its review by the agency began following the end of the U.S. government shutdown in January 2019.
The FDA informed Aimmune that the BLA will be reviewed under a 12-month target review period, as measured from the January 2019 start date. Consequently, review of the BLA may take until late January 2020.
Aimmune’s announced results, and the comments by Jayson Dallas, M.D., President and CEO of Aimmune, indicate that the ARTEMIS trial demonstrates that AR101 has significantly improved the ability of patients to tolerate the 1,000-mg dose of peanut protein in the exit food challenge. If approved, AR101 would become the first therapy for peanut allergy in both the American and European clinics. It might significantly reduce their risk of severe, potentially life-threatening reactions to peanut exposures and provide peace of mind to them and their families.
The phase 3 PALISADE trial results, which had demonstrated that 50.3% of AR101-treated patients tolerated a single highest dose of 1,000 mg of peanut protein after around six months of dose escalation followed by six months at a daily therapeutic dose of 300 mg, compared to 2.4% of placebo patients, were published in the New England Journal of Medicine in November 2018.
We love to see that 2% of the world’s children who cannot eat peanuts may soon enjoy them as some of their friends and family surely do.