Key Takeaways:
- Axoltis Pharma’s innovative drug, NX210c, shows promising results in a phase 1b clinical trial for treating neurodegenerative diseases.
- The drug exhibits a good safety profile and significant pharmacological effects, particularly in BBB integrity and neuroprotection.
- Plans for 2024 include a phase 2 trial in ALS patients and a phase 1b trial in Parkinson’s Disease, alongside advanced in silico modeling.
A New Era in Neurodegenerative Disease Treatment Axoltis Pharma, a pioneering French biopharmaceutical company, has announced encouraging results from its phase 1b clinical trial of NX210c, a novel peptide drug candidate. These findings mark a significant stride in the quest for effective treatments for neurodegenerative diseases.
From Concept to Clinical Success Following a successful single-ascending dose phase 1a study in 2020, which established NX210c’s safety in healthy volunteers, the phase 1b trial focused on multiple ascending doses to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in volunteers over 55. Conducted at the Centre for Human Drug Research in Leiden, the Netherlands, this trial involved 29 participants, with doses ranging up to 10mg/kg and a placebo group.
Promising Results: Safety and Efficacy The trial outcomes have been highly promising, showing that NX210c is safe and well-tolerated at all tested doses, with mild adverse events. Notably, the trial also applied Neurocart® tests and extensive EEG signal reviews, enhancing the neurological safety profile of NX210c.
Dr. Annette Janus, Championing Neurological Advancements Dr. Annette Janus, a neurologist and chief medical officer at Axoltis, highlighted the significant pharmacodynamic effects on biomarkers, indicating NX210c’s action on BBB integrity, neuroprotection, and neurotransmission. These results provide a solid foundation for further development of NX210c.
Showcasing at Neuroscience 2023 Axoltis recently presented these phase 1b results, combined with preclinical study findings, at Neuroscience 2023 in Washington DC, USA. The company is also set to deliver an oral presentation at AD/PD™ in Lisbon, Portugal, in March 2024, showcasing its contributions to the field.
Computational Modeling: Optimizing Drug Potential Utilizing a computational modeling approach based on clinical datasets, Axoltis has established a pharmacokinetics-pharmacodynamics relationship for NX210c, strengthening its therapeutic strategy. This innovative approach aids in evaluating and optimizing the drug’s potential for broader applications in neurodegenerative diseases.
A Focus on ALS and Parkinson’s Disease Looking ahead to 2024, Axoltis plans to initiate a phase 2 trial for NX210c in ALS patients, acknowledging the role of BBB deterioration in the disease’s progression. Additionally, the company has secured authorization to extend its phase 1b study with a cohort of Parkinson’s Disease patients, further broadening the scope of its research.
Partnering for Advanced Research Axoltis is collaborating with InSilicoTrials, Milan, Italy, experts in in silico modeling, to explore NX210c’s effects in neurodegenerative disease models. This partnership exemplifies the company’s commitment to leveraging cutting-edge technology in drug development.
Understanding the Blood Brain Barrier (BBB) The BBB plays a crucial role in protecting the brain from toxins and inflammatory components. Damage to the BBB is implicated in the progression of neurodegenerative diseases and may even trigger them, as evidenced in early-stage ALS.
NX210c: A Beacon of Hope Developed from the SCO-spondin glycoprotein, NX210c represents a promising therapy for neurodegenerative diseases and traumas. Its design stems from the most conserved sequence of the type 1 thrombospondin repeats of the SCO-spondin, addressing the need for regeneration and recovery in neurological disorders.
Axoltis Pharma: Pioneering Neurological Therapies Headquartered in Clermont-Ferrand and with offices in Lyon, France, Axoltis Pharma is dedicated to developing innovative drugs for neurodegenerative and neurotraumatic diseases. The company boasts a highly experienced team in drug development, particularly for neurological applications, and is supported by significant grants from Bpifrance and Région Auvergne-Rhône-Alpes.
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