French biopharmaceutical company Axoltis Pharma has announced promising results from its phase 1b clinical trial evaluating NX210c – an innovative therapy for neurodegenerative diseases and traumas.
Axoltis develops innovative drugs for neurodegenerative and neurotraumatic diseases with a high unmet medical need.
The results follow a single-ascending dose phase 1a study carried out in 2020, which had demonstrated a good safety profile for NX210c in healthy volunteers.
The phase 1b trial aimed at evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of the drug in healthy volunteers aged over 55 years.
Axoltis enrolled 29 healthy volunteers in a single-centre, randomised, double-blind, placebo controlled, dose escalation study conducted at the Centre for Human Drug Research, Leiden, the Netherlands.
The drug was administrated in a ten-minute infusion via an intravenous route, three times a week for four weeks.
The findings confirm that NX210c is safe and well-tolerated at all tested doses and any related adverse events observed were mild. Additionally, the specific neurologic safety profile of NX210c was strengthened by applying Neurocart, a series of central nervous system tests), included an extensive EEG signal review.
Dr Annette Janus, neurologist and chief medical officer at Axoltis, said: “This trial confirms the excellent safety and tolerability profile of NX210c.
“Moreover, we are excited to observe significant pharmacodynamic effects on blood and cerebrospinal fluid biomarkers, especially those important for BBB integrity, neuroprotection and neurotransmission.
“The results are very promising and provide a strong foundation to build on the NX210c drug development strategy,” said
By using a computational modelling approach based on the clinical dataset, Axoltis was also able to show an NX210c pharmacokinetics-
In parallel to this study in ALS, the company has already obtained authorisation to extend its phase 1b study in the Netherlands with a cohort of Parkinson’s disease patients.
Meanwhile, Axoltis is partnered with InSilicoTrials from Milan Italy to explore the potential effects of NX210c in neurodegenerative disease models.
