Both JAK inhibitors met the primary efficacy endpoint in improving hair regrowth on the scalp relative to baseline at week 24 (33.6 points and 49.5 points for JAK3 and TYK2/JAK1, respectively) as measured by the Severity of Alopecia Tool score (100 point scale).
The findings were presented during a Late-Breaking News session at the 27th European Academy of Dermatology and Venereology Congress in Paris, France.
Based on the totality of the data and the emerging clinical profiles, the investigational JAK3 inhibitor, which was recently granted Breakthrough Therapy designation from FDA for alopecia areata, is advancing to the next phase of development for moderate to severe AA and will continue to be evaluated for rheumatoid arthritis, Crohn's disease and ulcerative colitis.
PF-06700841 will continue to be evaluated for psoriasis, CD and UC.
This Phase 2a, randomised, double-blind, multicenter study evaluates the efficacy, safety, and tolerability of PF-06651600 and PF-06700841 compared to placebo in patients with moderate to severe AA. Patients were randomized 1: 1: 1 to receive: PF-06651600 (200 mg once daily [QD] for four weeks, followed by 50 mg QD for 20 weeks), or PF-06700841 (60 mg QD for 4 weeks, followed by 30 mg QD for 20 weeks), or placebo.
The study found that the placebo-adjusted mean (95% CI) in SALT change from baseline scores at Week 24 were 33.6 points (21.4, 45.7), (P
UroGen's UGN-103 IND accepted by FDA for bladder cancer treatment
MaaT Pharma reveals positive 18-month data for MaaT013 in GI-aGvHD
Innate Pharma advances Sanofi-developed NK cell engager to Phase 2 for blood cancer patients
Soligenix receives orphan drug designation from FDA for active ingredient in SuVax
Candel Therapeutics granted FDA Orphan Drug Designation for CAN-2409 in pancreatic cancer treatment
Lipogems completes patient enrolment in ARISE I US FDA IDE study
Amylyx Pharmaceuticals' AMX0035 shows promising impact on Wolfram syndrome symptoms
Roche attains CE Mark for first companion diagnostic for HER2-low metastatic breast cancer
Cadrenal Therapeutics' tecarfarin receives US FDA Orphan Drug Designation
BioCity Biopharma's BC2027 Phase one study IND application receives US FDA approval
Seres Therapeutics completes patient enrollment for SER-155 Phase 1B trial