Ethics committee in the Netherlands green lights Parkinson’s clinical trial
SHEPHERD slated to start in April to test cell energy-targeting therapy
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- A small clinical trial in the Netherlands, slated to launch in April, will test the oral therapy SUL-238 in early-stage Parkinson's patients.
- A medical research ethics committee gave the trial plan a green light.
- The treatment’s safety, tolerability, and pharmacological properties were previously tested in healthy volunteers.
GEN Pharmaceuticals has received ethical approval from an accredited medical research ethics committee in the Netherlands to conduct a small clinical trial testing SUL-238, its investigational medication for Parkinson’s disease.
With this approval, the company will activate a clinical site in Groningen in the northern Netherlands with patient enrollment planned to start in April, according to a press release announcing the committee’s decision. The Phase 2 SHEPHERD trial (NCT07322887) will assess SUL-238’s effects on mitochondrial function in an estimated 45 participants with early, untreated Parkinson’s.
Mitochondrial function refers to processes involving mitochondria, the powerhouses of cells, which include metabolism and cell health. The treatment candidate targets the underlying mechanisms in Parkinson’s disease.
“Following the ethical approval, we look forward to starting patient enrollment in the Netherlands. This Phase 2 trial will be another key milestone toward addressing neurodegenerative diseases at its biological foundation,” said Abidin Gülmüş, chairman of GEN.
Parkinson’s is caused by the gradual loss of dopaminergic neurons, the nerve cells that produce dopamine, a signaling molecule involved in motor control. Oxidative stress, a type of cell damage caused by reactive oxygen species, and damage to mitochondria, which serve as a cell’s energy-producing center, are believed to contribute to neuronal loss.
Clinical trial to test SUL-238 at high and low doses vs. a placebo
SUL-238, originally developed by Sulfateq and advanced as a collaboration between Sulfateq and GEN, is an oral small molecule designed to support mitochondrial energy production.
In preclinical models of neurodegenerative diseases, SUL-238 was shown to improve mitochondrial function, with a favorable pharmacokinetic profile and ability to penetrate the central nervous system (CNS), comprising the brain and spinal cord, according to the company. Pharmacokinetics refers to how a drug moves through the body.
The treatment’s safety, tolerability, and pharmacological properties were tested in a Phase 1 trial (NCT06277492) that enrolled healthy participants ages 40 and older. The participants were randomly assigned to receive SUL-238 or a placebo, at single or multiple ascending doses for 14 days.
The results showed that SUL-238 was safe and well tolerated, with adverse events generally mild or not treatment-related and similar between patients receiving SUL-238 and the placebo.
In both groups, SUL-238 was rapidly absorbed, reaching maximum levels in the blood after 1-1.5 hours. The treatment was also found to have high CNS penetration.
In the SHEPHERD trial, participants will be randomly assigned to receive SUL-238 at a high dose (1,500 mg), a low dose (500 mg), or a placebo, three times a day for 28 days, or nearly one month.
The main goal is to assess SUL-238’s effects on mitochondrial energy production by measuring mitochondrial-related metabolite levels in brain regions affected in Parkinson’s disease using magnetic resonance spectroscopy imaging.
Secondary outcomes include assessing the treatment’s effects on blood biomarkers of mitochondrial function, as well as its safety, tolerability, and pharmacological properties. SUL-238’s effects on easing Parkinson’s motor symptoms and improving cognitive function will also be evaluated.
The treatment is also being developed for Alzheimer’s disease, another neurodegenerative condition, as well as chronic heart, kidney, and lung diseases.
