Summary
- Pfizer achieved positive results from its phase 3 JADE MONO-1 study using Abrocitinib to treat patients with moderate to severe atopic dermatitis.
- The primary endpoint of the study was met in those treated with Abrocitinib that had a higher IGA response of 43.8% compared to placebo with 7% from baseline to week 12.
- A competing drug for Pfizer in atopic dermatitis would be Dupixent; a phase 3 study with Dupixent as a comparator is expected to be read out by the first half of 2020.
- With positive results from several studies, Pfizer is likely to file its FDA application for regulatory approval of Abrocitinib in atopic dermatitis in 2020.
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Pfizer (PFE) announced that it had achieved positive results for its phase 3 study using Abrocitinib to treat patients with moderate to severe atopic dermatitis. These positive results were observed against placebo in a 12-week study known as JADE MONO-1. This latest positive data sets up the company to potentially take on Sanofi (SNY) and Regeneron Pharmaceuticals (REGN) with Dupixent. Dupixent has the advantage because it was approved to treat atopic dermatitis back in 2017, but the latest data with Abrocitinib could mean a potential competing drug that could take some market share.
Latest Results Are Reinforced With Another Prior Study
Pfizer announced positive results from the late-stage study known as JADE MONO-1. This study recruited a total of 387 atopic dermatitis patients that were randomized to receive either: 200 mg of Abrocitinib, 100 mg of Abrocitinib, or placebo. The primary endpoint was looking for something known as the Investigator's Global Assessment (IGA) score from baseline to week 12. In essence, the measure was based on the response of clear skin (0) or almost clear skin (1). This was based on a 5 point scale. In addition, there had to be a reduction from baseline measurement of disease >=2 points in score at week 12. In terms of the primary endpoint, the measures were as follows:
- 200 mg of Abrocitinib - response rate was 43.8%
- 100 mg of Abrocitinib - response rate was 23.7%
- placebo - response rate was 7%
As you can see above, doubling the dose to the highest level of 200 mg of Abrocitinib had an IGA response rate of 43.8%. This was much better than placebo only achieving a 7% response rate. This JADE program is strong, but I believe that investors can greatly benefit from additional catalysts. The first of which involves additional data to be shared from the JADE program in 2020. The second catalyst would be data from the long-term extension study known as JADE EXTEND. This is a long-term study to evaluate the safety and efficacy of Abrocitinib in patients with moderate to severe atopic dermatitis. This long-term study is needed because the primary endpoint for JADE MONO-1 was only being evaluated for 12 weeks. The JADE EXTEND study is looking at treating patients for 96 weeks. Besides the positive data from JADE MONO-1, it is important to highlight that data released a few weeks prior pretty much reinforces the efficacy of Abrocitinib in treating this patient population. That is, about a few weeks ago, Pfizer had reported that the co-primary endpoint of IGA score from baseline and >=2 point reduction was met in another similar late-stage study known as JADE MONO-2. It is good to see such confirmation from another similar study.
Competitors
As I noted in the beginning, Regeneron Pharmaceuticals and Sanofi have their drug to treat atopic dermatitis known as Dupixent. Dupixent has been approved for a few indications, but, back in March of 2019, Regeneron expanded the label to include adolescents with atopic dermatitis. It is believed that Dupixent, for atopic dermatitis (also known as Eczema) plus the asthma indication also, could reach peak sales of $7 billion. It is not going to be easy for Pfizer to come into this space; however, with an arsenal of data, I believe it has a good shot. One place where Abrocitinib may be able to compete on is in terms of limiting itching that these patients experience. Consider that after 12 weeks of treatment with the highest dose of the drug, about 57.2% people experienced at least a 4-point improvement on pruritus measurement. There were improvements in pruritus (itching) within the first 2 weeks. Dupixent had several trials and the highest number it had was a 59% improvement and the lowest was a 36% improvement from another study. It's hard to directly compare studies, but this in effect gives some idea of whether or not Abrocitinib might be able to compete against Dupixent. There is another item to watch on this front. Pfizer expects to finish another phase 3 study (A third one) that makes use of Dupixent as a comparator drug. Results from this late-stage study are expected by the first half of 2020. This will be a good study to see if Abrocitinib ends up being superior in safety and efficacy compared to Dupixent for patients with atopic dermatitis. With all 3 studies in hand in 2020, Pfizer will then likely move to file for FDA approval of Abrocitinib for atopic dermatitis.
