Trial Testing Oral Therapy Anle138b Now Enrolling Patients in UK

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by Patricia Inácio, PhD |

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A Phase 1 clinical trial in the U.K. is recruiting patients with mild to moderate Parkinson’s to assess MODAG Neuroscience Solutions‘ investigational oral therapy anle138b, which seeks to slow or halt disease progression.

The trial (NCT04685265) will be conducted at a single site at Nottingham University Hospital, in central England, according to a press release from Cure Parkinson’s. Researchers are looking to enroll 24 adults, ages 50 to 80, who are able to walk unaided.

More information on enrollment is available here, as well as by email. Patients in the U.K. may get additional information via telephone, by calling 03303 031 000.

“Anle138b is taken by mouth, easily enters the brain, and preclinical research indicates that it is very good at reducing levels of aggregated [clumped] alpha synuclein [protein] inside cells. The reduction of alpha-synuclein in the brain has been reported to reverse Parkinson’s-like motor symptoms in animal models,” Cure Parkinson’s says on its website.

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During the trial, the participants will be divided into five groups and randomly assigned to receive multiple ascending doses of anle138b, starting at 150mg, or a placebo for seven days.

The trial will assess the therapy’s safety and tolerability, and the effect of food — taking the medication while fasting versus being fed — on its pharmacokinetics, which refers to the movement of a medicine into, through, and out of the body.

Scientists also will evaluate Anle138b’s effects on motor symptoms and its levels in the participants’ cerebrospinal fluid, the liquid that surrounds the brain and spinal cord.

Anle138b was designed to bind harmful forms of alpha-synuclein, a key protein involved in Parkinson’s disease. These alpha-synuclein clumps are toxic and can disrupt the normal functioning of brain cells. The therapy works by dissolving these toxic structures and prevent new ones from forming, with the goal of slowing or halting the progression of Parkinson’s.

Antibodies have been used to target alpha-synuclein clumps, but they require intravenous (into-the-blood) infusions and are often too large to cross the blood-brain barrier — a semipermeable membrane that protects the brain and spinal cord. Conversely, anle138b is a small oral molecule that can easily enter the brain.

Initially developed to treat multiple system atrophy (MSA), also characterized by the accumulation of alpha-synuclein, MODAG hopes anle138b will benefit all synucleinopathies, or diseases that feature alpha-synuclein clumps.

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In preclinical studies with models of MSA, Parkinson’s, and Alzheimer’s disease, treatment with anle138b reduced the buildup of the alpha-synuclein toxic clumps and delayed disease progression.

Also, anle138b was found to reverse Parkinson’s-related motor symptoms in mouse models of the disease.

An earlier Phase 1 clinical trial (NCT04208152) — the first testing the medicine in humans — was completed in 2020. That trial involved 68 healthy volunteers who were randomly assigned to receive escalating doses of anle138b, or a placebo.

The therapy showed excellent safety and tolerability profiles, and reached therapeutic dose levels in the blood, according to MODAG.

Cure Parkinson’s has supported what it calls “this promising area of research.”

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