Advancements and Challenges in Clinical Trials: A 2024 Overview
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Clinical Trials: Latest Research & Developments
- Bemdaneprocel has accelerated its development following productive talks with the US FDA, aiming to enter a registrational trial to potentially slow or halt the progression of a neurodegenerative disease.
- Chinese firms have initiated seven global Phase III trials in 2024, with BeiGene, Genfleet, and InnoCare planning to add four more studies this year.
- LB is planning a Phase III program for its amisulpride derivative, following positive Phase II data, focusing on safety and convenience with a lower dose that more easily passes through the blood-brain barrier.
- Acelyrin is advancing to Phase III trials for its anti-IGF-1 agent, lonigutamab, in thyroid eye disease, despite uncertainties about its competitiveness against existing treatments.
- Two treatments targeting elF2B, a regulator involved in motor neurone disease, have missed their primary and secondary endpoints in a landmark platform trial.
- CARsgen's anti-Claudin 18.2 CAR-T therapy has met its endpoint in a pivotal Phase II trial for gastric/gastroesophageal junction adenocarcinoma, leading towards a China NDA filing.
- Neumora faced a setback as its kappa opioid receptor antagonism treatment for depression failed in the first of three Phase III studies, resulting in a sharp decline in its share price.
- Novo Nordisk and Eli Lilly are expected to release significant readouts in the obesity/diabetes space, with Novo Nordisk aiming to catch up to its rival.
- Mendus has secured FDA and EMA support for pivotal studies of its allogenic leukemia-derived dendritic cell vaccine, following promising Phase II data.
- BMS's Sotyktu succeeded in two Phase III psoriatic arthritis trials, and Novo's Alhemo was approved in the US for hemophilia A and B with inhibitors.
- Roche's gene therapy for spinal muscular atrophy, currently limited to intravenous administration in patients under two years, has passed a Phase III test for its intrathecal candidate, potentially expanding its use to children and young adults.
This year's clinical trials landscape highlights both the promise and the hurdles in developing new treatments, with significant advancements in some areas and notable challenges in others.