Chinese Drugmaker Innocare Reports Positive Late-Stage Trial Results for Psoriasis Oral Treatment

Chinese drugmaker Innocare Pharma reports that its experimental oral treatment fadeucravacitinib met its primary and secondary endpoints in a Phase III trial for moderate-to-severe plaque psoriasis. The company plans to advance regulatory filings to compete in a growing market. Meanwhile, clinical data highlights other advancements, including Takeda's TYK2 inhibitor zasocitinib demonstrating statistical superiority over Bristol Myers Squibb's deucravacitinib in a head-to-head trial.

Oral psoriasis treatment efficacy

• ▪Approximately 8.66 million people in China live with psoriasis, and the number of cases in the country is on the rise.
• ▪Oral pills such as Bristol Myers Squibb's Sotyktu and Amgen's Otezla offer convenient treatment options in a plaque psoriasis market largely dominated by injectables.
• ▪Innocare Pharma's experimental oral treatment fadeucravacitinib met its primary and multiple secondary endpoints, showing a consistent treatment effect in a Phase III trial for moderate-to-severe plaque psoriasis.
• ▪Beijing-based Innocare Pharma plans to advance regulatory filings for its oral drug fadeucravacitinib following the completion of its Phase III study.

TYK2 inhibitor trial results

• ▪In the phase 2 STRIDE trial, a majority of moderate-to-severe plaque psoriasis patients receiving 40 mg twice daily of the TYK2 inhibitor ESK-001 achieved 75% skin clearance.
• ▪Zasocitinib targets TYK2, a central mediator of the inflammatory axis involving cytokines IL-23 and IL-17 in psoriasis pathogenesis.
• ▪In the LATITUDE Atlas trial, 35% of patients treated with the TYK2 inhibitor zasocitinib achieved completely clear skin (PASI 100) at week 16.
• ▪A phase 2b clinical trial of the oral TYK2 inhibitor zasocitinib showed up to one-third of moderate-to-severe plaque psoriasis patients achieved complete skin clearance after 12 weeks.
• ▪The LATITUDE Atlas trial results showed that the zasocitinib response rate at week 16 was two and a half times greater than that of deucravacitinib.

Topical psoriasis treatment efficacy

• ▪A phase 2a study of the topical phosphodiesterase 4 inhibitor PF-07038124 demonstrated superior efficacy compared with placebo in patients with mild to moderate atopic dermatitis and plaque psoriasis.
• ▪The topical treatment PF-07038124 resulted in significant Psoriasis Area and Severity Index score improvements with no serious adverse events or application site reactions.

Biologic therapy skin cancer risks

• ▪Researchers emphasized the need for long-term cohort studies to evaluate the safety of biologic therapies and suggested establishing guidelines for their use in high-risk populations.
• ▪A meta-analysis study indicated that patients with psoriasis or psoriatic arthritis treated with biologics have a higher risk of developing melanoma and nonmelanoma skin cancer compared with the general population.

Drug pricing cost-effectiveness

• ▪A study suggests that using an efficiency frontier approach to negotiate drug prices for psoriasis biologics could lead to significant price reductions while aligning costs with clinical benefits.
• ▪The efficiency frontier study found that prices for certain psoriasis drugs, such as infliximab-dyyb and ixekizumab, could be reduced by up to 71% to match the cost-effectiveness of the most efficient treatments.

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