Accropeutics announced today that the first psoriasis patient has been dosed in the phase 2clinical trial of the TYK2/JAK1 inhibitor AC-201 in China. This study is amulticenter, randomized, double-blind, parallel group, placebo-controlled phaseII clinical trial to evaluate the efficacy, safety, and pharmacokineticcharacteristics of AC-201 in subjects with moderate to severe plaque psoriasis.
CFS warmly congratulates Accropeutics for achieving this important milestone! As Accropeutics 's strategic CDMO partner, CFS has been providing comprehensive services for this project,including formulation development, GMP manufacturing, process scale up, andclinical supply support for both Australian and China domestic clinical trials,ranging from toxicology through Phase I&II clinical trials. During theproject execution, CFS significantly enhanced the drug’s oral bioavailability byusing our Amorphous Solid Dispersion (ASD) technology platform, completing theentire process from toxicology formulation development to the GMP manufacturingof First-In-Human (FIH) clinical samples in less than five months.
The CFS clinicalsupply team efficiently customized the double-blinding packaging solutionaccording to the clinical protocol under tight deadlines, earning unanimousrecognition from the sponsor. We completed high-quality delivery from primaryand secondary packaging to finished products within eight weeks, ensuring thesmooth and efficient export of medicines to the clinical trial site inAustralia. Additionally, we proactively adjusted to clinical protocol changes,ensuring the timely enrollment and dosing of the first patient by the sponsor.
AC-201 is a novel oral small-molecule inhibitor of TYK2/JAK1 with high activity, selectivity, and safety margin. AC-201 caneffectively bind to the pseudo kinase domain (JH2) of TYK2/JAK1, stabilizingthe self-inhibitory conformation of the pseudo kinase domain on the kinasedomain, thereby inhibiting the function of TYK2/JAK1 kinase, and has noeffect on the JAK2/JAK2 signaling pathway. AC-201 is intended to treatautoimmune diseases such as psoriasis and systemic lupus erythematosus.AC-201 has completed the long-term toxicity studies (including 3, 6, 9-months) and reproductive toxicity studies (stages I and II). Studyresults indicate that AC-201 has an excellent safety profile andsupports the clinical development of Phase II and III. AC-201 demonstratedexcellent safety and tolerability in healthy volunteers in Australia and China.The average peak concentration and exposure level increased proportionally withdose and were not affected by food. No significant drug accumulation wasobserved after multiple dosing of AC-201. Biomarkers indicated that low tomiddle doses of AC-201 effectively blocked disease causing pro-inflammatorycytokines. The overall phase I data support the progression of AC-201 to phaseII for the treatment of psoriasis and other autoimmune disease patients.