ILB is our exciting new pleiotropic molecule with the potential to treat several neurological diseases and the cause of glaucoma through multiple mechanisms.
It has highly specific properties that address the underlying pathology to activate repair and protection.
A NEW APPROACH
ILB’s mechanism of action may either reduce the triggers that lead to cell death or prevent further pathology even if triggers are present. By addressing the underlying processes of disease, ILB could significantly improve outcomes for people suffering from otherwise untreatable progressive and disabling conditions.
- Broad applicability in acute and neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS) and stroke plus traumatic brain injury and glaucoma.
- Addresses the underlying pathology of the diseases, enabling self-repair instead of just treating the symptoms.
- Subcutaneous dosing simplifies administration for the patient and makes it suitable for longer term treatment.
“The pleiotropic mechanisms of action of ILB that we have revealed indicate the utility of this drug to treat many acute and chronic degenerative conditions.”
Professor Ann Logan,
Scientific Director, Neuregenix Ltd.
University of Birmingham, UK.
ALS Sahlgrenska University Hospital
ALS University of Birmingham
Glaucoma University of Birmingham
ILB has a solid set of non-clinical and clinical data covering a broad range of indications and further studies with our development partners are planned. These will be used as a basis for CRO-monitored Phase II clinical trials planned for ALS, glaucoma, stroke, and traumatic brain injury.
Completed clinical studies
20 subjects were dosed once. ILB was found to be safe and well-tolerated when administered as an intravenous bolus dose of 1.5 mg/kg followed by a 20-min infusion of 3.0 mg/kg and 5-h infusion of up to ~ 9 mg/kg. A minor AE and no SAEs were recorded.
24 subjects were dosed once intravenously ranging from 3 to 24 mg/kg. ILB was found safe and well-tolerated in all administered doses. There were minor AEs reported and no SAEs.
Crossover intravenous and subcutaneous dosing was administered to 12 healthy volunteers. No SAEs or withdrawals were recorded. Mild bruising around the injection site was noted up to 24 h after injection. No hypersensitivity reactions were recorded. Subcutaneous dosing was found suitable for future administration. Mean absolute bioavaliability was 94%.
Planned clinical studies
Several CRO-monitored Phase II studies in different indications are either planned or under way.
15 patients will be treated with ILB during a 4-week period. The study will be conducted at Sahlgrenska hospital in Gothenburg, Sweden.
15 patients will be treated with ILB during a 10-week period. The study will be conducted by Neuregenix at the University of Birmingham, UK.
20 patients will be treated with ILB for 1 week. The study will be conducted by Neuregenix at University of Birmingham, UK.
30 active patients and 15 controls will be treated with ILB for one week. The study will be conducted as an international multicentre study. Contact Tikomed AB for more information on any of these studies.