In recent years, there has been a steady increase in the number of agents approved to treat inflammatory bowel diseases (IBD), which has provided physicians with an increasing number of options to treat Crohn’s disease (CD). However, this progress is not reflected in the number of approved treatments for pediatric IBD patients. Of the seven biologics approved to treat moderate to severe CD in adults, only two have been approved for pediatric patients, Remicade (infliximab) and Humira (adalimumab), with the most recent approval given to Humira in 2014. To address the lack of progress in medications coming to market to treat pediatric CD, Eli Lilly and Janssen have formed a collaborative cross-company pediatric platform trial to establish a master protocol to help streamline the process of asset evaluation, as described last September in the journal, Therapeutic Innovation & Regulatory Science.

 

Adeleke Badejo, Senior Analyst – Immunology at GlobalData, comments: “Acting as a pilot study, this collaboration could illustrate the use of a master protocol as a feasible solution to overcome the obstacles associated with pediatric drug studies and accelerate the evaluation process.” 

 

The lack of approvals within pediatrics can be attributed to the numerous challenges associated with these studies; the smaller patient population, in addition to special measures required to ensure the ethics and safety of these trials, which all leads to trial delays, extended studies, and higher costs. Facing these challenges, many companies are incapable or unwilling to evaluate therapies in children or adolescents following approval for adults in the same intended indication. 

 

Typically used to study therapies in oncology, the use of master protocols may allow companies to overcome the obstacles associated with pediatric studies and thereby make the approval of therapies more feasible. The agreement between Eli Lilly and Janssen was established to allow the two companies to share resources for the goal of accelerating the evaluation of the respective companies’ assets, mirikizumab and Tremfya (guselkumab).  

 

Badejo continues: “The implications of and the foreseeable strategic benefit from Lilly and Janssen’s use of a master protocol is illustrated by the measures the two companies took to hide the partnership, such as submitting the Investigator Brochures under separate cover (EMA) and cross-referencing the company specific INDs (FDA) to maintain confidentiality.” 

 

In addition to providing a solution to the dearth of pediatric medications, the collaboration has the potential to salvage the mirikizumab program, Eli Lilly’s anti-IL23 pipeline asset currently in Phase 3 clinical development. Mirikizumab has lost significant ground to AbbVie’s Skyrizi (risankizumab), and to a lesser extent Janssen’s Tremfya, the other agents in this drug class. In addition to Skyrizi’s recent supplementary CD indication, both Skyrizi and Tremfya have received US FDA approval in psoriasis in 2017 and in 2019, respectively. These developments were compounded by Lilly’s announcement that it has discontinued development of its agent for psoriasis in April of last year. 

 

Badejo notes: “If this collaboration between Janssen and Eli Lilly results in mirikizumab entering the CD pediatric market before Skyrizi, then it will be a significant point of distinction that Lilly will use to separate from the rest of the drug class and potentially salvage the mirikizumab program for Lilly in the end.”