Rejuvenate Biomed NV (“Rejuvenate”), a biomedical company developing novel combination drugs for age-related diseases, today provides an update on its development pipeline and strategy.
Rejuvenate has commenced its first Phase 1 clinical trial assessing the company’s lead candidate RJx-01 for the treatment of sarcopenia. This trial marks Rejuvenate’s maturation from preclinical- to clinical-stage company and is accompanied by the growth of the team and a move to the new Health Campus in Diepenbeek, Belgium.
Rejuvenate’s Phase 1 clinical trial is designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of RJx-01 in the treatment of sarcopenia. Sarcopenia is the progressive loss of skeletal muscle mass and strength, which can be either chronic (age-induced) or acute (inactivity-induced), affecting up to 22% of 65-year-olds and 50% of 80-year-olds, with no current treatment options.
The methodology of this randomized, double-blind, placebo-controlled trial is the first of its kind: up to 42 healthy subjects (65- to 75-year-olds) will be hosted on-site in a hotel with full professional supervision for two weeks. As part of the trial, they will be placed in a leg cast to induce mild acute sarcopenia through muscle disuse while being on treatment with RJx-01. Once the cast is removed, subjects will be closely monitored over a four-week period as they continue to be treated with RJx-01. Subsequently, they will undergo a personalized rehabilitation program.
Because RJx-01 is a novel combination of known drugs, there are already extensive safety data available for the constituent compounds. This means the trial will also be able to assess treatment effectiveness and collect information on possible sarcopenia biomarkers and the potential usefulness of imaging techniques for future trials. Results will be based on a combination of classic and hi-tech assessment techniques, including data from wearable health tech devices, mechanistic evaluations, questionnaires, biomarkers, and medical imaging. Topline results are expected in the 4th quarter this year.
Growth and maturation of the company
Accompanying the company’s maturation, Rejuvenate announces its move to the new Health Campus in Diepenbeek (Belgium), a project led by POM Limburg (“Provinciale Ontwikkelingsmaatschappij Limburg”). The company is also opening a lab in the BioVille incubator for the expansion of its proprietary preclinical research platform based on the model organism C. elegans.
In step with the company’s new activities, the Rejuvenate team will be further complemented with additional staff for the expansion of Rejuvenate’s C. elegans and AI platform and its clinical activities.
Dr. Ann Beliën, PhD, Founder and Chief Executive Officer of Rejuvenate, said: “We are very excited to initiate this unique clinical trial. Based on extensive preclinical data, we are confident that RJx-01 will demonstrate effectiveness in the treatment of sarcopenia. The benefit of starting with known safety data in hand is that we’ve been able to design a groundbreaking clinical trial, using innovative methods to progress our knowledge of both RJx-01 and of the disease itself. The backing of our investors Rejuveron and Vesalius Biocapital has paved the way for us to achieve our milestones according to plan. We’re thankful to the regulatory authorities for their support and to the subjects who will take part over the next few months. I’m also personally grateful to our wonderful team, without which our company’s achievements wouldn’t have been possible. Rejuvenate has come a long way in the past few years, and the pace of acceleration is thrilling to see! Our ambition is to grow even further and become one of the major players on the biomed scene, improving people’s health spans around the world.”