Olumiant leads the alopecia Jak pack

Snippets

Lilly and Incyte today claimed the first pivotal win for a Jak inhibitor in alopecia – but it might not be the last. The groups’ Olumiant succeeded in Brave-AA2, but Pfizer is not too far behind with its Jak3/TEC inhibitor ritlecitinib, whose phase II/III study is also set to report in 2021. Lilly is not disclosing data from Brave-AA2, only saying that both doses tested, 2mg and 4mg once daily, met the primary efficacy endpoint, the percentage of patients achieving a severity of alopecia tool (Salt) 20 score at 36 weeks. Ritlecitinib’s Allegro-2b/3 trial also evaluates Salt 20, at week 24, so if it hits it will be interesting to see how the projects stack up. Safety will also be under scrutiny given Jak inhibitors’ track record. Lilly said that in Brave-AA2 Olumiant’s safety profile was consistent with experience in rheumatoid arthritis, for which it is FDA approved, and atopic dermatitis, for which it has EMA approval. Still, Olumiant’s US label has a black box warning for serious infections, malignancies and thromboses, which might hurt its chances in a disease like alopecia. The sellside forecasts Olumiant sales of $1.2bn in 2026, according to EvaluatePharma consensus, but none of this is expected to come in alopecia.

Jak inhibitors in active clinical development for alopecia
Project Company Pharma class Trial ID Data due
Phase III
Olumiant Lilly Jak 1 & 2 inhibitor BRAVE-AA2  Toplined Mar 2021, 2mg & 4mg doses met primary endpoint
BRAVE-AA1  Completed Feb 2021
Ritlecitinib (PF-06651600) Pfizer Jak 3/TEC inhibitor Allegro-2b/3  Completed Dec 2020
CTP-543 Concert  Jak 1 & 2 inhibitor Thrive-AA1 Completes Feb 2022
Thrive-AA2 Due to start H1 2021
Phase II
Jaktinib (oral) Suzhou Zelgen Biopharmaceuticals Jak 1-3 inhibitor NCT04034134 (severe) Completed Dec 2020
Jaktinib (topical) Suzhou Zelgen Biopharmaceuticals Jak 1-3 inhibitor NCT04445363 (mild to moderate) Completed Dec 2020
Source: EvaluatePharma & clinicaltrials.gov.

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