Using Protein Biomarkers Enhances Clinical Trial Outcomes

It is crystal clear that clinical trials are the surest way to bring new drugs into the market. While most clinical trials are costly, nine out of ten drugs in clinical development are never approved. Most of these treatments fail in clinical trials due to a lack of the desired effect, and some of these failures are attributed to poor target selection during the drug discovery process. Matching the right treatment to the right patient based on molecular biomarkers can bring more promising results in clinical trials.

Precision Medicine Requires Reliable Biomarkers

Precision medicine aims to treat patients as individuals. It also targets treating patients in stratified groups with distinct molecular profiles. Early identification and verification of biomarkers in drug development stages will ensure that the new therapies are tested on the intended patients. Besides, it will save drug development costs and reduce the attrition rate in clinical trials.

Trials that are using biomarkers in selecting patients have a higher probability of proceeding to the next levels. For instance, 10.7% of trials of cancer drugs that used biomarkers in stratifying patients got market approval. Using biomarkers in early trials can give a functional basement on how later trials can be worked to boost their chances of succeeding. Besides, despite rapid growth in precision medicine, only a few percentages of trials are stratifying patients using biomarkers.

Searching for a Perfect Biomarker

Most biological processes relate to proteins, and most drugs do target proteins and not a nucleic acid. Identifying the levels of clinically relevant proteins in samples of patients will give you more insights into the patient’s disease. It will help you in selecting the best treatment and monitor how efficiently it is working.

In the past, insufficient depth and poor reproducibility made proteomics on body fluid less sufficient. But due to new technology, clinical proteomics is becoming an area of interest.

Identification of Reliable Biomarkers from Biological Fluids is Now Possible

Innovative approaches in large scale measuring of proteins is one of the key technological advancements in proteomics. The data-independent acquisition (DIA), as it is known, gives unbiased and comprehensive results. The method is also offering quantitative proteomic profiling, which reveals reproducible and robust biomarkers even in biological fluids.

Need to Go Deep into the Plasma Proteome

Blood plasma is more natural to collect and contains a variety of proteins that indicate what’s taking place in the body of a patient. It is, therefore, a preferred fluid for biomarker discovery. Besides, it also has proteins that originate from the tissues that are nurtured by blood flow, making it a window to the body. As a result, its composition can also change regularly due to biological processes. Large scale plasma proteomics and biomarkers are now achievable according to recent studies by Nestle and Biognosys after a recent study. It was found that the levels of 271 proteins that carry fat around changed significantly after weight loss hence presenting a large number of potential biomarkers candidates. It was concluded that weight loss reduced inflammation and improved the metabolism of patients.

You can bet that biomedical companies like Genprex Inc. (NASDAQ: GNPX) are looking keenly at including the use of biomarkers during their R&D.

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