TikoMed AB reports positive Phase II clinical data for the treatment of amyothropic lateral sclerosis in data published by PLOS ONE

STOCKHOLM, May 25, 2022 /PRNewswire/ — A new study with ILB®, the leading clinical drug candidate of the TikoMed platform, provides positive safety and tolerability results and the first clinical evidence of the 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 ALS patients for five weeks, ALS progression was halted and/or reversed for all study participants assessed using the d-scales. ALSFRS-R and Norris validated clinical assessments that assess a wide range of patients. relevant functions. Additionally, clinical improvement was associated with a positive impact on blood biomarkers (eg, decreased muscle atrophy biomarkers and normalized metabolic biomarkers). Importantly, the ILB® treatment was safe and well tolerated, with no serious adverse effects or deaths. It was also telling that there were no patient withdrawals throughout the study. The therapeutic benefits associated with the administration of ILB® diminished 3 to 4 weeks after the last dose.

“These early results from this ALS study are exciting because ILB® provided clinical benefits without significant side effects,” said lead researcher Dr. Lennart Persson from the Department of Clinical Neuroscience, Institute of Neuroscience and Physiology at the University of Gothenburg.

The scientific manager of the Professor program Anne Logan of University of Warwick added “The potential for a safe and effective disease-modifying drug that works by mobilizing the body’s own repair systems is enormous and relevant for the treatment of many neurodegenerative diseases. These positive clinical results provide considerable momentum to carry out further research. ‘other pivotal trials to benefit the patients, families and society who share the burden of these currently incurable diseases.’

The Phase II open-label clinical trial of TikoMed 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 (both sexes) with ALS of intermediate severity. Safety and efficacy outcome measures were recorded weekly during treatment and at regular intervals for an additional 70 days. Functional and laboratory biomarkers were assessed before, during and after treatment.

“To date, many trials have not been able to identify an agent that reverses or even halts the progressive symptoms of ALS, which is why these clinical results with ILB®, demonstrating both the safety and tolerability while supporting the drug’s potential as a disease-modifying therapy, are very promising,” said Anders Kristensson, CEO of TikoMed. “Preclinical studies of our ILB® program have also demonstrated the drug’s unique ability to enhance endogenous repair mechanisms and rebalance inflammatory responses, providing a potentially invaluable new mechanism of action in the treatment of neurodegenerative diseases”

About ALS

Amyotrophic lateral sclerosis (ALS) is a fatal progressive disease that causes motor neurons (nerve cells that control muscle cells) and muscles to degenerate. As motor neurons are lost, the muscles they control become weak and nonfunctional, leading to muscle weakness, disability, and eventually death. The clinical signs of ALS are weakness and atrophy of voluntary muscles, increased muscle tone with increasing spasticity and decreased fine motor skills, and increasing difficulty swallowing, speaking and breathing. From the time of diagnosis, patients usually survive only three to five years with a gradually reduced quality of life over this period. There is no effective cure, and currently approved drugs have only marginal effects on the rate of decline, even in the most responsive patients.

PLOS ONE is a fully open-access international peer-reviewed journal. For more details on the study “An open label Phase II 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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https://news.cision.com/tikomed/r/tikomed-ab-reports-positive-phase-ii-clinical-data-for-the-treatment-of-amyothropic-lateral-sclerosi,c3544760

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