STOCKHOLM, May 26, 2022 /PRNewswire/ -- A new study with TikoMed's platform lead clinical drug candidate ILB®, provides positive safety and tolerability results and the first clinical evidence of encouraging clinical efficacy of ILB® in the treatment of amyotrophic lateral sclerosis (ALS). The study was published in PLOS ONE today.
In a Phase II study of ILB® administered to patients with ALS for five weeks, the progression of ALS was halted and/or reversed for all study participants assessed using the validated ALSFRS-R and Norris clincal rating scales that score a broad range of patient relevant functions. In addition, the clinical improvement was associated with positive impact upon blood biomarkers (e.g. a decrease in muscle atrophy biomarkers and a normalization of metabolic biomarkers). Importantly, ILB® treatment was safe and well tolerated with no serious adverse effects or deaths. It was also revealing that there were no patient withdrawals throughout the study. The therapeutic benefits associated with ILB® administration decreased 3-4 weeks after the last dosage.
"These early results from this ALS-study are exciting as ILB® provided beneficial clinical effects without significant side effects", said principal investigator, Dr Lennart Persson from the Department of Clinical Neuroscience, Institute of Neuroscience and Physiology at the University of Gothenburg.
The scientific lead of the program Professor Ann Logan from the University of Warwick added "The potential for a safe and effective disease-modifying drug that acts by mobilising the bodies own repair systems is huge and relevant to the treatment of many neurodegenerative conditions. These positive clinical results provide considerable momentum to perform further pivotal trials for the benefit of the patients, families and society who shares the burden of these currently incurable diseases."
TikoMed's phase II open label clinical trial conducted at Sahlgrenska University Hospital in Gothenburg, Sweden, evaluated the safety, tolerability and possible efficacy of subcutaneous injections of ILB® in the treatment of thirteen patients (of both sexes) with ALS of intermediate severity. Safety and efficacy outcome measures were recorded weekly during treatment and at regular intervals for a further 70 days. Functional and laboratory biomarkers were assessed before, during and after treatment.
"As of yet, numerous trials have been unable to identify any agent that reverses or even halts the progessive symptoms of ALS which is why these clinical results with ILB®, demonstrating both safety and tolerability whilst supporting the drug's potential as a disease modifying treatment, are very promising", said Anders Kristensson, CEO of TikoMed. "Preclinical studies from our ILB® program have also demonstrated the drug's unique ability to enhance endogenous repair mechanisms and rebalance inflammatory responses providing a new, potentially invaluable mechanism of action in the treatment of neurodegenerative diseases"
Amyotrophic lateral sclerosis (ALS) is a lethal progressive disease that causes degeneration of motor neurons (nerve cells that control muscle cells) and muscle. As motor neurons are lost, the muscles they control become weak and non-functional, thus leading to muscle weakness, disability, and eventually death. The clinical signs of ALS are weakness and atrophy of voluntary muscles, increased muscular tone with increasing spasticity and decreased fine motor skills, as well as increasing difficulties of swallowing, speech and respiration. From the time of diagnosis, patient survival is typically only three to five years with progressively reduced quality of life over this time period. No effective cure exists, and currently approved drugs have only marginal effects on the rate of decline, even in the best responding patients.
PLOS ONE is a peer-reviewed, fully open access international journal. For full study details on "A phase II open label clinical study of the safety, tolerability and efficacy of ILB® for Amyotrophic Lateral Sclerosis", please access the publication https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0267183
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