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Eli Lilly JAK inhibitor successfully promotes hair regrowth in phase 3 clinical trials
Eli Lilly JAK inhibitor successfully promotes hair regrowth in phase 3 clinical trials. Eli Lilly and Incyte announced that the JAK inhibitor OLUMIANT (Baricitinib) tablet jointly developed by both parties for the treatment of severe alopecia areata (AA) in adults has reached its primary endpoint in a Phase 3 clinical trial. In AA patients with hair loss ≥50%, both 2-mg and 4-mg doses of Baricitinib can significantly improve the patient’s hair regrowth in the 36th week of treatment.
This is the first JAK inhibitor that has been proven effective in a phase 3 clinical trial of AA patients. Baricitinib is expected to be the first JAK inhibitor approved for the treatment of severe alopecia areata in adults when the FDA has not yet approved relevant therapeutic drugs. The patient brings the gospel.
Alopecia areata is a non-scarring hair loss that often occurs in hairy parts of the body and can occur at any age, but it is more common in young adults and there is no significant difference in incidence between the sexes. About 5%~10% of alopecia areata can develop gradually or rapidly into total or general alopecia. There are approximately 147 million AA patients worldwide.
Baricitinib was originally a JAK1/2 tyrosine kinase inhibitor developed by Incyte. In December 2009, Eli Lilly and Incyte reached an exclusive global cooperative development agreement for Baricitinib. So far, the product has been approved in more than 70 countries to treat moderate to severe active rheumatoid arthritis. In March 2020, the FDA granted Baricitinib a breakthrough therapy designation for the treatment of AA.
BRAVE-AA2 is the first phase 3 study of Baricitinib with positive results in AA patients. In 546 adult patients with severe alopecia (hair loss ≥50%) for at least 6 months (not more than 8 years), compared with placebo, the scalp and hair regrowth of patients treated with Baricitinib was statistically significantly improved . Eli Lilly will provide additional post-study data in the first half of this year.
It is reported that in addition to alopecia areata, clinical studies of Baricitinib in the treatment of systemic lupus erythematosus (SLE), juvenile idiopathic arthritis (JIA) and COVID-19 are also being advanced globally.
In addition to Eli Lilly’s Baricitinib, a number of studies on the treatment of hair loss are being advanced globally.
The Phase 2 clinical trial of the topical androgen receptor (AR) antagonist Furitan in the treatment of androgenetic alopecia by the pioneering pharmaceutical industry is expected to obtain relevant data by the end of this year. Zejing Bio’s JAK kinase small molecule inhibitors Jacktinib and Hengrui Pharmaceutical’s SHR0302 is also undergoing phase 2 clinical trials. Concert’s JAK1/2 inhibitor deuterated rucotinib analog CTP-543 FDA has obtained the fast track qualification and breakthrough drug qualification for the treatment of AA granted by the FDA, and Pfizer’s PF -06651600 has also entered Phase 3 clinical phase.
(source:internet, reference only)