Immunic Inc (NASDAQ:IMUX) chief medical officer Dr Andreas Muehler discusses the importance of clinical trials in the biotech industry to mark Clinical Trials Day on May 20.
Dr Muehler noted that Immunic focuses on translating research ideas into clinical trials to demonstrate clinical proof of concept as well as safety and efficacy of a drug candidate. He explained the stages of clinical development, from preclinical trials to late-stage phase 3 trials and commercialization. Preclinical trials involve testing in animals and cell cultures to ensure safety before human testing begins.
Phase 1 trials assess safety and pharmacokinetics, while phase 2 trials determine the appropriate dosage. Phase 3 trials involve large-scale testing to obtain statistically significant outcomes for regulatory approval. Dr Muehler emphasized the importance of continuous clinical development, even after drug approval, to monitor for rare side effects and test in different populations.
Clinical trials at Immunic are organized by medical and clinical operations teams and executed with the help of contract research organisations (CROs) to manage the trials across various countries. Dr Muehler highlighted the challenges in clinical trials, such as patient recruitment and the need for effective planning and communication with key opinion leaders and investigators. He shared that staying in close contact with investigators through meetings, site visits, and newsletters helps in efficient trial execution and patient enrolment.
Immunic's approach has been successful in rapidly enrolling patients for trials, particularly in multiple sclerosis studies, he added.
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