Protagonist Therapeutics Awaits FDA Decision on Two Drugs
Protagonist Therapeutics is highlighting its expertise in peptide-based drug development as it awaits FDA decisions on two of its medicines. A company interview details their path from research to regulatory submission for the two therapies.
- One of the drugs awaiting an FDA decision is rusfertide, a potential treatment for polycythemia vera, a rare blood cancer that causes the overproduction of red blood cells. The other is icotrokinra (also known as JNJ-2113), an oral peptide being evaluated for the treatment of moderate-to-severe plaque psoriasis. - The development of icotrokinra is a collaboration with Janssen Biotech, Inc., a subsidiary of Johnson & Johnson, highlighting how smaller biotech firms often partner with larger pharmaceutical companies to bring a drug to market. This partnership involves shared responsibilities in clinical development and navigating the regulatory approval process. - The creation of these drugs relies heavily on computational biology and bioinformatics. Professionals in these tech-focused roles use computer modeling and data analysis to design and predict the function of peptides, which are short chains of amino acids, before they are even synthesized in a lab. A typical day for a computational biologist might involve writing code, analyzing large datasets, and collaborating with lab-based scientists. - To get these drugs to the FDA, a different set of professionals runs the clinical trials. Clinical Research Associates (CRAs) are responsible for monitoring these trials, ensuring patient safety, and verifying the data collected from patients and doctors. This career path is more patient-facing and operational compared to the computational roles. - Educational pathways for these careers differ significantly. A computational biologist or bioinformatician typically has a bachelor's degree in a field like biology or computer science, often followed by a master's or Ph.D. with a focus on programming and data analysis. In contrast, a CRA position often requires a background in life sciences or nursing, and there are opportunities to enter the field with a bachelor's degree. - The development of a drug from initial research to FDA submission is a long and complex process that can take over a decade. It involves a "drug discovery" phase, where potential molecules are identified, a "preclinical" phase of lab and animal testing, and then multiple phases of human clinical trials to test for safety and effectiveness. - An individual with a Ph.D. in a field like molecular biology or biochemistry would likely be involved in the early-stage discovery and research of new drugs. An M.D. might be more involved in the later stages of clinical development, designing and overseeing the clinical trials, and interacting with the FDA. - Protagonist Therapeutics specializes in "peptide therapeutics," which are designed to be highly specific and potent. A key challenge in this field, which a variety of scientists work to solve, is making these drugs stable enough to be effective in the human body and, in the case of icotrokinra, able to be taken orally.
