First Patient Treated in Phase 2 Trial of NE3107 for Motor Symptoms

Yedida Y Bogachkov PhD avatar

by Yedida Y Bogachkov PhD |

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The first patient has been treated in BioVie’s Phase 2 clinical trial assessing the impact of its investigational therapy, NE3107, on the motor symptoms of Parkinson’s disease.

Study results for the Phase 2 trial, known as NM201, are expected by the end of 2022.

“Enrollment of the first patient in our human development program is a significant milestone for BioVie, and we look forward to data readout for NM201 in mid-2022, “ Cuong V. Do, CEO of BioVie, said in a press release.

NE3107 is a small, oral therapy designed to cross the blood-brain barrier — the highly selective, permeable membrane that protects the brain and spinal cord from the external environment — that has anti-inflammatory and insulin-sensitizing effects.

These effects are believed to be due to NE3107’s ability to inhibit ERK, a protein involved in neuroinflammation and insulin resistance — two common features of neurodegenerative diseases like Parkinson’s.

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In preclinical studies, NE3107 was found to lessen inflammation within the nervous system and ease insulin resistance, slowing neurodegeneration and improving nerve function.

In a primate model of Parkinson’s, NE3107 in combination with levodopa led to a greater improvement in motor control than either therapy alone. Furthermore, the combination reduced the severity of levodopa-induced dyskinesia, or spontaneous involuntary movements, without decreasing the medication’s benefit.

The therapy also showed neuroprotective activity, preserving roughly twice as many dopamine-producing neurons — the nerve cells affected in Parkinson’s — compared with a placebo.

The NM201 Phase 2 trial (NCT05083260) is a multi-center, placebo-controlled study, looking at the safety, tolerability, and pharmacokinetics of NE3107 in Parkinson’s. Pharmacokinetics refers to the movement of a medicine into, through, and out of the body.

The U.S. Food and Drug Administration (FDA) approved the trial in October last year.

Participants will be treated with a combination of carbidopa/levodopa and NE3107 or a placebo. The company intends to enroll 40 adults, ages 30-75, currently taking immediate-release levodopa/carbidopa with defined “off” periods, or periods when Parkinson’s medications are no longer effective and symptoms re-emerge.

The study participants will be given either 20 mg of NE3107 or a placebo, twice a day for 28 days. Safety assessments will look at patient health and the potential for medication interactions affecting levodopa’s pharmacokinetics and activity.

Exploratory efficacy assessments for both motor and non-motor symptoms will be evaluated using a variety of measures, including the motor disease society unified Parkinson’s disease rating (MDS-UPDRS) parts 1–3, the Hauser on/off diary, and the non-motor symptom scale.

“Our NM201 study is designed to be an efficient, cost-effective assessment of the safety and pharmacokinetics profile, as well as the potential efficacy of NE3017 for the treatment of PD [Parkinson’s disease],” Do said.