Retrotope Inc has announced that the first participants have been enrolled in their new phase 2 clinical trial. This trial evaluates the safety and efficacy of the compound RT001 in people living with ALS. The study intends to recruit 40 participants living from different countries. Retrotope expects the study to enroll rapidly, and data to be available by the end of 2021. The full press release issued by Retrotope can be found here.
TRICALS Centres in the Netherlands and Sweden are participating. Professor Leonard van den Berg, chairman of TRICALS, is principle investigator of the study. “Despite the growing global awareness and advocacy for ALS, the therapeutic needs of people living with this devastating disease remain unmet,” said Professor van den Berg. “Our team is excited to be involved in this clinical study as we believe that RT001, by virtue of its ability to down-regulate lipid peroxidation and protect cellular and mitochondrial membranes, represents a promising approach to mitigating the debilitating course of ALS. We look forward to enrolling patients in this trial and helping advance the evaluation of this novel treatment.”
RT001 is made from slightly modified linoleic acid. Linoleic acid is typically part of a normal human diet and is found in most oils. RT001 can protect cells from lipid peroxidation – a process that is believed to cause damage in several neurodegenerative diseases, including ALS. RT001 has previously been shown to be safe when administered to humans. However, RT001 can currently only be prescribed in research settings.
More information about the study and eligibility criteria can be found here.
*** Update April 6th ***
Please note that enrolment has now been completed. Thank you to everyone who has shown interest in participating in this trial.