AC-201 / Accro Biosci, Fosun Pharma - LARVOL DELTA

Efficacy and Safety of a Selective Oral TYK2/JAK1 Inhibitor, AC-201, in Patients with Plaque Psoriasis: A Phase II, Randomized, Double-blinded, Placebo-Controlled Trial (EADV 2025) - P2 | "The most common Treatment-Emergent Adverse Events (TEAEs) reported were upper respiratory tract infection (8.6% for 25mg BID, 34.3% for 50mg BID,13.5% for 100mg QD and 10.8% for placebo) and hypertriglyceridemia (8.6% for 25mg BID, 17.1% for 50mgBID, 8.1% for 100mg QD and 18.9% for placebo). Conclusion 12-week treatment with oral AC-201 results in significant clinical improvement in patients with moderate-to- severe plaque psoriasis and is generally well tolerated."

Clinical • Late-breaking abstract • P2 data • Dermatology • Dyslipidemia • Hypertriglyceridemia • Immunology • Infectious Disease • Psoriasis • Respiratory Diseases • TYK2

Efficacy and Safety of a Selective Oral TYK2/JAK1 Inhibitor, AC-201, in Patients with Plaque Psoriasis: A Phase II, Randomized, Double-blinded, Placebo-Controlled Trial (ESDR 2025) - P2 | "12-week treatment with oral AC-201 results in significant clinical improvement in patients with moderate-to-severe plaque psoriasis and is generally well tolerated."

Clinical • P2 data • Dermatology • Dyslipidemia • Hypertriglyceridemia • Immunology • Infectious Disease • Psoriasis • Respiratory Diseases • TYK2

Accro Bioscience to Present Phase II Data of AC-201 for Plaque Psoriasis at the European Academy of Dermatology & Venereology Congress 2025 in Paris (PRNewswire)

P2 data • Psoriasis

Fosun Pharma Gains Exclusive Rights for Accro's Novel Small-Molecule Drug Candidate AC-201 in Greater China (Fosun Pharma Press Release) - "Under the agreement, Accro will receive an upfront payment and near-term milestone payment totaling RMB 80 million (including an upfront payment of RMB 60 million, and a milestone payment of RMB 20 million upon completion of manufacture technology transfer), as well as up to RMB 76 million in development milestone payments. Accro will also receive commercial milestone payments and tiered royalties of up to double-digit percentages based on product sales in the licensed regions."

Licensing / partnership • Psoriasis

Accropeutics Announces Positive Data from Phase 2 Trial of AC-201, an oral, selective TYK2/JAK1 Inhibitor, for the treatment of Moderate-to-Severe Plaque Psoriasis (PRNewswire) - P2 | N=145 | NCT06972888 | Sponsor: Accro Bioscience (Suzhou) Limited | "Accro Bioscience (Suzhou) Limited (Accropeutics)...announced positive results from their Phase 2 clinical trial of AC-201, an oral, selective TYK2/JAK1 Inhibitor, in moderate-to-severe plaque psoriasis. Primary and key secondary endpoints including Psoriasis Area and Severity Index (PASI)-75, PASI-90(≥75% and 90% reduction in PASI) and static Physician's Global Assessment (sPGA)-0/1 (score of 0 'clear' or 1 'almost clear') were achieved following 12 weeks of treatment in all 3 dosing groups of AC-201....At week 12, PASI-75 response rates were 8.1% for placebo (PBO), 31.4% for 25mg BID (P=0.012 vs. PBO), 74.3% for 50mg BID (P<0.001 vs. PBO), and 59.5% for 100mg QD (P<0.001 vs. PBO). The PASI-90 response rate was 2.7% for placebo, 20% for 25mg BID (P=0.02 vs. PBO), 48.6% for 50mg BID (P<0.001 vs. PBO), and 24.3% for 100mg QD (P=0.007 vs. PBO)."

P2 data • Psoriasis

A Phase II Clinical Study of AC-201 Tablets in Subjects With Plaque Psoriasis (clinicaltrials.gov) - P2 | N=145 | Completed | Sponsor: Accro Bioscience (Suzhou) Limited

New P2 trial • Dermatology • Immunology • Psoriasis

Accropeutics Secured $12 Million in Series B Plus Financing (PRNewswire) - "The proceeds from the Series B Plus financing will be used to generate more clinical data for AC-101, a RIPK2 inhibitor, in an ongoing Phase Ib clinical trial for patients with Ulcerative Colitis (UC). Accropeutics' other clinical-stage assets include AC-201, a selective TYK2/JAK1 inhibitor, currently in an ongoing Phase II trial for patients with moderate-to-severe Psoriasis, and for multiple additional indications; and AC-003, a RIPK1 inhibitor, currently in an ongoing Phase Ib trial for patients with acute Graft-versus-Host Disease (aGvHD). The company also has multiple I&I assets in the pre-clinical stage."

Financing • Acute Graft versus Host Disease • Psoriasis • Ulcerative Colitis

A study to Evaluate the Effects of Food on Pharmacokinetics of AC-201. (ANZCTR) - P1 | N=12 | Terminated | Sponsor: Accro Bioscience (Australia) Pty Ltd | Initiation date: Jun 2023

Trial initiation date • Trial termination • Dermatology • Immunology • Psoriasis

Part 1 and Part 3:A Study to evaluate the safety,Tolerability,Pharmacokinetics of AC-201 (ANZCTR) - P1 | N=82 | Recruiting | Sponsor: Accro Bioscience (Australia) Pty Ltd | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Dermatology • Immunology • Psoriasis

A study to Evaluate the Effects of Food on Pharmacokinetics of AC-201. (ANZCTR) - P1 | N=12 | Not yet recruiting | Sponsor: Accro Bioscience (Australia) Pty Ltd

New P1 trial • Dermatology • Immunology • Psoriasis

Part 1 and Part 3:A Study to evaluate the safety,Tolerability,Pharmacokinetics of AC-201 (ANZCTR) - P1 | N=82 | Not yet recruiting | Sponsor: Accro Bioscience (Australia) Pty Ltd

New P1 trial • Dermatology • Immunology • Psoriasis

TYK2/JAK1 Inhibitor AC-201 of Accropeutics Bioscience gained Human Research Ethics Committees (HREC) permission for Phase I (PRNewswire) - "Accropeutics Bioscience announced that its oral small molecule TYK2/JAK1 inhibitor AC-201 has been approved by the Australian Human Research Ethics Committee (HREC) to launch a clinical phase I trial in Australia. The trial will be a randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and food effects of AC-201 in healthy adults. AC-201 is a novel small molecule inhibitor of TYK2/JAK1 with high activity, selectivity, and safety window....It demonstrated significant efficacy in multiple animal models of diseases, including psoriasis, and is intended for the treatment of psoriasis and other inflammatory and autoimmune diseases."

New P1 trial • Immunology • Inflammation • Psoriasis