Pfizer and Eli Lilly Secure Approvals for International Multicenter Clinical Trials of Two Novel Imported Drugs in China

Source | Medical Perspectives

The Center for Drug Evaluation (CDE) of China’s National Medical Products Administration announced that two imported new drugs have received implicit approval for clinical trials, both of which are international multicenter clinical trials. The two products are Pfizer’s novel TNFSF15 blocker PF-06480605 injection and mirikizumab injection, an IL-23 monoclonal antibody developed by Eli Lilly and Company.

Source: CDE Official Website

1. Pfizer: PF-06480605 Injection

Mechanism of Action: Novel TNFSF15 Inhibitor

PF-06480605 is a novel TNFSF15 inhibitor under development by Pfizer, formulated as a fully human immunoglobulin G1 (IgG1) monoclonal antibody. According to Pfizer’s official website, the product has advanced to Phase 2 clinical trials globally, with ulcerative colitis (UC) as the intended indication. Research indicates that the pathogenesis of UC is closely associated with multiple genes, including TNFSF15. The protein product of this gene, TL1A, exhibits physiological activities such as T-cell activation and promotion of inflammatory cytokine secretion, playing a significant role in immune regulation and inflammatory diseases.

In June this year, PF-06480605 submitted an Investigational New Drug (IND) application in China. This marks its first clinical trial approval in the country, with plans to develop it for the treatment of moderate-to-severe ulcerative colitis. On the ClinicalTrials.gov website, a total of four clinical trials have been registered for this product. Among them, two are early-phase studies conducted in healthy volunteers, and the other two are Phase 2 studies in patients with moderate-to-severe ulcerative colitis.

In a Phase 1 dose-escalation study conducted in healthy subjects, PF-06480605 demonstrated favorable safety and tolerability profiles, with higher target engagement compared to the placebo group. These findings support further investigation of PF-06480605 as a therapeutic agent for inflammatory bowel disease and other inflammatory disorders. Notably, there are currently few investigational new drugs targeting TNFSF15 blockade in clinical development.

2. Eli Lilly: mirikizumab injection

Mechanism of Action: IL-23 Inhibitor

Mirikizumab is a fully humanized monoclonal antibody developed by Eli Lilly and Company that targets the p19 subunit of IL-23. It binds to the p19 subunit of IL-23, thereby blocking IL-23-mediated inflammatory responses. Currently, this product is undergoing multiple clinical trials for the treatment of immune-mediated diseases, including psoriasis, ulcerative colitis, and Crohn's disease.

Mirikizumab Injection Receives Three Implicit Approvals for Clinical Trials in China, All of Which Are International Multicenter Clinical Trials Targeting Moderate to Severe Active Crohn's Disease.

According to public information, mirikizumab previously yielded positive results in a Phase 2 clinical trial for the treatment of moderate-to-severe Crohn’s disease. The trial results demonstrated that, compared with placebo, mirikizumab significantly reduced clinically and endoscopically measured disease activity after 12 weeks of treatment.

In China, mirikizumab has also received multiple implied approvals for clinical trials from the Center for Drug Evaluation (CDE), targeting indications for moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.

It is worth noting that in July this year, mirikizumab met the primary and all key secondary endpoints, as well as all key secondary endpoints compared with the active control, in the Phase 3 OASIS-2 clinical trial for patients with moderate-to-severe plaque psoriasis.

References:

[1] Center for Drug Evaluation (CDE), National Medical Products Administration of China. Retrieved Aug 27, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=25#

[2] Lilly's Mirikizumab Superior to Cosentyx® (secukinumab) in a Phase 3 Study for Patients with Moderate to Severe Plaque Psoriasis. Retrieved July 17, 2020, fromhttps://investor.lilly.com/news-releases/news-release-details/lillys-mirikizumab-superior-cosentyxr-secukinumab-phase-3-study

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