IMUX - Immunic CMO discusses role of clinical trials in biotech development for Clinical Trials Day

(NewsDirect)

Immunic Inc (NASDAQ:IMUX) chief medicalofficer Dr Andreas Muehler discusses the importance of clinical trialsin the biotech industry to mark Clinical Trials Day on May 20.

Dr Muehler noted that Immunic focuses ontranslating research ideas into clinical trials to demonstrateclinical proof of concept as well as safety and efficacy of a drugcandidate. He explained the stages of clinical development, frompreclinical trials to late-stage phase 3 trials and commercialization.Preclinical trials involve testing in animals and cell cultures toensure safety before human testing begins.

Phase 1 trials assess safety and pharmacokinetics, while phase 2trials determine the appropriate dosage. Phase 3 trials involvelarge-scale testing to obtain statistically significant outcomes forregulatory approval. Dr Muehler emphasized the importance ofcontinuous clinical development, even after drug approval, to monitorfor rare side effects and test in different populations.

Clinical trials at Immunic are organizedby medical and clinical operations teams and executed with the help ofcontract research organisations (CROs) to manage the trials acrossvarious countries. Dr Muehler highlighted the challenges in clinicaltrials, such as patient recruitment and the need for effectiveplanning and communication with key opinion leaders and investigators.He shared that staying in close contact with investigators throughmeetings, site visits, and newsletters helps in efficient trialexecution and patient enrolment.

Immunic's approach has been successful in rapidly enrollingpatients for trials, particularly in multiple sclerosis studies, headded.

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