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Personalized medicine for pathological circadian dysfunctions

Rachel L Skelton1, Jon M Kornhauser2, Barbara A Tate3

  • 1Insight Genetics, Inc. Nashville, TN, USA.

Frontiers in Pharmacology
|July 8, 2015
PubMed

Insights

Personalized medicine, using patient profiling and companion diagnostics (CDx), can improve success rates for central nervous system (CNS) drug development. This approach aims to increase the approval of new therapeutics for circadian rhythm disorders.

Area of Science:

  • Neuroscience
  • Pharmacology
  • Genetics

Background:

  • Recent approval of a circadian disorder therapeutic fuels interest in new medicines for circadian disruption.
  • Drug development for central nervous system (CNS) disorders faces high failure rates.
  • Personalized medicine is standard in oncology, improving drug development success.

Purpose of the Study:

  • To explore the potential of personalized medicine to reduce clinical trial failure rates in CNS drug development.
  • To review current circadian trials and lessons from a recent circadian therapeutic approval.
  • To discuss tailoring personalized medicine for future circadian disorder clinical trials.

Main Methods:

  • Review of current clinical trials for circadian disorders.
  • Analysis of the history and application of personalized medicine in oncology.
  • Examination of a recently approved circadian therapeutic and its development pathway.

Main Results:

  • Personalized medicine, including companion diagnostics (CDx) and patient profiling, enhances clinical trial efficiency.
  • Enriching patient populations in trials increases statistical significance and success rates.
  • This approach has the potential to significantly reduce the high failure rate in CNS drug development.

Conclusions:

  • Personalized medicine offers a viable strategy to improve the success of developing therapeutics for circadian disorders.
  • Lessons from oncology and recent circadian therapeutics can guide future CNS drug development.
  • Implementing personalized medicine can lead to more approvals for treatments targeting circadian abnormalities.
Keywords:
circadian disorderscircadian therapeuticscompanion diagnosticspatient enrollmentpersonalized medicinetargeted therapeutics

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