Phase 2 trial of NE3107, an anti-inflammatory, may open in summer

Oral treatment, a possible monotherapy, to be given newly diagnosed patients

Margarida Maia, PhD avatar

by Margarida Maia, PhD |

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BioVie is planning to launch in late summer a Phase 2b clinical trial of NE3107, its investigational anti-inflammatory small molecule, as an initial and stand-alone treatment for Parkinson’s disease, the company announced in a release.

The trial aims to recruit between 100 and 150 newly diagnosed Parkinson’s patients to test how well first-line treatment with NE3107, given on its own for six months, improves motor function compared with a placebo.

Its design will allow the study to be stopped as soon as treated patients, relative to the placebo group, achieve a four- to five-point advantage on the MDS-Unified Parkinson’s Disease Rating Scale’s motor score (Part III). Such a design may cut the time and cost of getting potential treatments to patients.

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BioVie set its Parkinson’s program as a priority, investing part of the $18.8 million in cash it raised in a recent equity financing round that generated $21 million in gross proceeds.

“Prioritizing the Parkinson’s program allows us to focus limited resources on the trial that should provide topline results by mid-2025 … and potentially lead the way to the first new therapy for [Parkinson’s] since the advent of levodopa over five decades ago,” said Cuong Do, company president and CEO.

Parkinson’s symptoms, which include tremor, stiffness, and slowness of movement, are caused by damage to nerve cells in the brain that produce dopamine, a chemical involved in movement control.

Growing evidence suggests that the inflammatory response, which normally helps in healing, goes awry in Parkinson’s patients and promotes a long-lasting cycle of inflammation that further damages these dopaminergic neurons, contributing to disease progression.

NE3107 is an orally available small molecule designed to enter the brain and bring the inflammatory response under control. It also aims to inhibit inflammation-driven insulin resistance, a condition causing cells to stop responding to insulin, the hormone that helps sugar enter cells to be used as energy. Insulin resistance occurs in the brains of Parkinson’s patients, and it is thought to contribute to disease development.

Phase 2a trial suggested NE3107 might be a sole Parkinson’s therapy

Recent data from an earlier Phase 2a clinical trial (NCT05083260) in the U.S., which enrolled 46 patients with moderate or severe Parkinson’s, showed that 28 days of twice daily treatment with oral NE3107 plus levodopa eased both motor and nonmotor symptoms.

About one-quarter of treated patients also reported better motor function in the morning, before taking their standard levodopa/carbidopa treatment, while none of those on a placebo experienced these benefits. NE3107 was reported to be well tolerated, with no serious side effects related to treatment.

Preclinical studies in a Parkinson’s marmoset model also showed that monkeys treated with NE3107 retained nearly twice as many dopamine-producing nerve cells than did untreated marmosets, supporting the use of NE3107 as a monotherapy (single therapy).

NE3107 also is being developed as a potential Alzheimer’s disease treatment. Building on data from a Phase 3 clinical trial in patients, where NE3107 outperformed a placebo at slowing cognitive decline, BioVie plans to test a once-a-day formulation that it expects to have ready in 2025.

“We have great hopes for the Alzheimer’s program, but resources and the expected availability of a once-daily version of NE3107 makes delaying a year the best solution for patients and shareholders,” Do said.