FDA OKs Phase 2 Trial of Oral NE3107 in Easing Inflammation
The launch of a Phase 2 trial into the safety and early efficacy of oral NE3107 in treating Parkinson’s disease patients with motor fluctuations while on levodopa was approved by the U.S. Food and Drug Administration (FDA), BioVie, the therapy’s developer, announced.
BioVie plans to initiate patient enrollment for the trial, called the NM201 study (NCT05083260), before the end of the year, it said in a press release. Results are expected in mid-2022.
NE3107 is a small molecule that can cross the blood-brain barrier — a highly selective, permeable membrane that controls what crosses into the brain from the bloodstream — and has potential anti-inflammatory, and insulin-sensitizing effects.
These effects are thought to stem from NE3107’s ability to block ERK, a protein involved in neuroinflammatory responses and insulin resistance. Of note, neuroinflammation and insulin resistance are common features in neurodegenerative diseases, including Parkinson’s.
ERK inhibition by NE3107 may ultimately affect downstream components of the pro-inflammatory ERK pathway, the company reported, to further decrease neuroinflammation and potentially slow neurodegeneration.
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 disease, specifically, NE3107 eased movement abnormalities. Monkeys given NE3107 in combination with levodopa — a mainstay treatment of Parkinson’s motor symptoms — also had a greater improvement in motor control than was evident with either medication alone, BioVie reported on its website. The therapy also showed neuroprotective activity, promoting a greater survival of neurons in the animals’ brains compared with a placebo.
The Phase 2 trial will be a double-blind, placebo-controlled study of NE3107’s safety and efficacy given with levodopa/carbidopa to adult patients.
It aims to enroll 40 patients, ages 30 to 75, who are taking levodopa at 400 mg or more daily but have a history of motor fluctuations and “reliable” early morning “off” periods — a state in which levodopa is no longer working and symptoms, such as tremors, rigidity, and slow movement, are re-emerging.
Participants will be randomized to NE3107 at 20 mg, or to a placebo, twice a day for 28 days.
Safety assessments will focus on standard measures of patient health, as well as potential medication interactions affecting levodopa’s breakdown in the body, and its activity.
The effects of NE3107 on Parkinson’s symptoms will be assessed by the motor disease society unified Parkinson’s disease rating (MDS-UPDRS) parts 1–4, the Hauser on/off diary, and the non-motor symptom scale. All are tests to evaluate the degree of Parkinson’s symptoms.
Trial site and contact information is not yet available.
According to the company, NE3107’s potential to lessen neuroinflammation and insulin resistance led BioVie to decide to test the investigative therapy in people with Parkinson’s and with Alzheimer’s disease.
A Phase 3 trial (NCT04669028) in the U.S., still enrolling, is studying NE3107 at 20 mg twice daily in up to 316 adults with mild to moderate Alzheimer’s. Results are expected in late 2022.
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