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Citeline’s Trialtrove has recently expanded its disease coverage to include trials evaluating therapeutic treatments for neonatal brain injury (NBI), also known as neonatal encephalopathy or hypoxic ischemic encephalopathy. Historically, the primary cause of NBI was attributed to acquired insults sustained at birth, such as asphyxia. More recently, a much broader array of underlying causes, particularly metabolic ones, have been found to account for these injuries, especially in premature infants. Some forms of NBI occur with alarming frequency, such as stroke, which occurs in 1 out of 4,000 live births. All forms have a high mortality risk, various serious neurological disorders, such as epilepsy, as well as learning and physical disabilities (Ferriero, DM, 2004). Considering the myriad causes and consequences of NBI, what does the clinical landscape look like for drug development in this field?

 

 

The infographics below provide an overview of the new NBI module in Trialtrove. This relatively small field of clinical research is predominantly in early stage development, with 42 of the 60 clinical trials (70%) in phase I – II. (Figure 1)

 

 

 

 

 

A look at the mechanisms of action (MOAs) that are tested in 2 or more trials (Figure 2) shows that EPO receptor agonists are evaluated in the highest number of NBI trials. This MOA includes various forms of the approved drug erythropoietin (EPO) and are primarily phase II+ trials. Interestingly, stem cell therapies are highly represented in NBI trials. The placenta and umbilical cord blood are rich sources of stem cells and can provide autologous stem cells for transplantation since these are the neonate’s own tissues. This regenerative medicine approach will be exciting to follow as clinical development progresses beyond the current phase I-II stages. It is also notable that drugs with many different MOAs are in development for this indication, perhaps reflecting the broad array of underlying brain injury causes. There are only two phase III/IV and IV studies, both of which evaluate iron or vitamin supplementation (in some cases to the expectant mother), pointing to a large unmet need in NBI treatment.

 

 

 

 

 

The high incidence of NBI has not led to correspondingly high clinical trial activity to date. Where is the trial activity occurring and who is sponsoring these trials? The map below shows the global distribution of NBI research across all trial statuses, with the hottest spot being in the United States (13 trials), followed by China and the United Kingdom (7 each). (Figure 3)

 

 

 

 

 

The final figure provides the numbers of trials by sponsor type (Figure 4). The vast majority (56 of 60) are sponsored by academic/medical centers, alone or in collaboration with government or cooperative entities. The academic sponsorship also offers an explanation for why most studies (52 of 60) are single country studies (not shown), rather than being multinational or global in scope. Only four trials have an industry sponsor.

 

 

 

 

 

This profile of Trialtrove’s neonatal brain injury module highlights how limited the therapeutic options currently are for an important condition. Do industry pipelines contain other therapeutic candidates that can be developed for NBI? When new developments occur, Trialtrove will be sure to capture them – tune in.

 

 

Check out the Infogr.am blog summary here 

Ferriero, DM, Neonatal Brain Injury, N Engl J Med 2004; 351:1985-1995

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