Increasing Clinical Trial Success

Super-precision genetic-based design increasing safety and efficacy

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Clinical Trial Success PDF

Super-precision clinical trials

Over the past decade, there has been strong growth in precision clinical trials with 46% of approved drugs having a genetic biomarker on the label. These drugs rely on a genetic variant that codes for an amino acid mutation that either inactivates or activates a gene. However, this mutation is only present in a percentage of tumors and there are likely many other mutations that have a similar impact on gene function and disease. The problem is that it is very labor-intensive and takes a long time to identify all of these other genetic variants of concern, so these variants are not considered in clinical decisions. This is where Heligenics empowers a superior design of clinical trials with its Gene Mutation Libraries (GMLs) measuring the impact of each genetic variant in a GigaAssay experiment. Comparisons to GMLs from cells treated with drugs can identify resistance mutations.

Now, all these GML variants can be used to segregate patients in a clinical trial. We call this new data-driven approach to clinical trial design Super-precision clinical trials since they are expanding on the precision clinical trials that have become routine practice.

Five Facts

  • 46 % of recent drug approvals have a genotype on the label
  • Many genetic variants have similar effects on gene function
  • Precision clinical trials can be scaled to use a whole gene
  • Better than artificial intelligence
  • Get more drugs approved

Since most clinical trials fail, the world needs a better design

Single gene mutations have transformed drug approvals

Heligenics gene mutation libraries will revolutionize it

Trials based upon whole gene genotyping is more comprehensive that a single genetic marker

Heligenics is helping drug manufacturers scale the use of a genetic biomarker to a whole gene biomarker. Recent examples show that although only a few variants may be in clinical practice, there are sometimes 1000s of variants in a gene with a similar effect that are not yet being used. The successful precision drug trial concept can be scaled to use all mutations in a target gene with Heligenics GMLs.

Unlike AI, this revolutionary technology is based on experimentally derived, not theoretical data – allowing you to identify which subjects have side effects or are unlikely to respond, therefore significantly improving the odds of your next drug getting approved.

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