Pfizer Inc. PFE announced that it has initiated a pivotal phase IIb/III clinical study to evaluate its oral JAK3 inhibitor candidate, PF-06651600, for treating moderate to severe alopecia areata (“AA”).
Alopecia areata is an autoimmune dermatologic condition that results in patchy non-scarring hair loss, usually affecting the scalp. There is no FDA approved drug presently available to treat this condition, which can lead to high levels of depression and anxiety in patients.
The study will evaluate the safety and effectiveness of the candidate in nearly 660 patients, including adults and adolescents with 50% or greater scalp hair loss. Currently, PF-06651600 enjoys breakthrough therapy designation, which was granted based on positive data from the successfully completed phase IIa study.
In September 2018, Pfizer announced data from the phase IIa study, which demonstrated that the candidate improved hair re-growth on the scalp compared to the baseline after 24 weeks of treatment.
Apart from AA, PF-06651600 is being developed for rheumatoid arthritis (“RA”), Crohn’s disease and ulcerative colitis (“UC”).
A glimpse of Pfizer’s price trend reveals that it has outperformed the industry in the past six months. The stock has gained 14% compared with the industry’s 6.9% growth.
Markedly, Pfizer’s strong pipeline of kinase inhibitors includes JAK inhibitors, which are being developed for several inflammatory indications. Moreover, the company has four other kinase inhibitors in several stages of developments for multiple indications that include atopic dermatitis, psoriasis, Crohn’s disease, UC, AA, RA and inflammatory bowel disease.
Among approved kinase inhibitors, Xeljanz is a successful product in Pfizer’s portfolio. In the first nine months of 2018, Xeljanz garnered approximately $1.2 billion.
The company also has biosimilar products of other drugs generating tens of billions of dollars, which are indicated for inflammatory diseases in its portfolio. Pfizer already markets biosimilar version of Merck MRK/J&J’s JNJ Remicade, while biosimilar of AbbVie’s ABBV Humira is in late stage development.
Successful development of kinase inhibitors and Humira biosimilar along with approved drugs, will create a strong portfolio of inflammatory drugs going forward.
Zacks Rank
Pfizer has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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