BioVie Inc (NASDAQ:BIVI) has unveiled early data from the Phase 3 study of its investigational drug NE3107 in patients with mild to moderate Alzheimer’s Disease, highlighting the preliminary baseline metabolic and inflammation characteristics of the study population.
The update sent its shares higher, up 14% at US$3.92 late morning on Monday.
The data was presented as a poster titled “Metabolic Dysregulation in Probable Alzheimer’s Disease” by BioVie’s chief medical officer Dr. Joseph Palumbo at the American Neurological Association Annual Meeting, being held from September 11 to 13, 2023.
“The poster presentation does not reveal new data readouts. Instead, it provides an understanding of the patient population at the start of the trial, as understood to date,” Dr. Palumbo explained in a statement.
“When looking at this preliminary baseline data in its totality, we see that patients enrolled in the trial have underlying medical conditions that are known risk factors for dementia.”
The data showed that at baseline, the majority of the study population had abdominal obesity (85%), hypertension (61%), and impaired glucose metabolism (IFG/T2D: 52%).
Almost half of patients had a form of insulin resistance (47%), 40% had hypertriglyceridemia and 30% had hypercholesterolemia, coded as having elevated inflammatory markers.
BioVie noted that, since these are known dementia risk factors, the company believes NE3107 could potentially help patients improve on some of these factors, as shown in prior clinical trials.
Additionally, both Aβ+ and Aβ− patients with dementia were enrolled in the study and had, at baseline, comparable Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scores indicative of mild dementia.
Aβ+ patients had worse ADAS-Cog12 and Mini-Mental State Examination (MMSE) scores, indicating lower cognitive functioning, while the enrolled Aβ− patients had significantly higher inflammation, insulin resistance, IFG, and hypertension.
A subgroup analysis showed higher degrees of impaired glucose metabolism and insulin resistance among the APOE ε4− patients compared to those with APOE ε4+ and comparable baseline MMSE scores, indicating that both groups had mild to moderate cognitive impairment.
NE3107’s potential ability to reduce inflammation and insulin resistance suggests that it may be of benefit to both Aβ+ and Aβ− patients as well as APOE ε4+ and APOE ε4− patients, according to BioVie.
The company is aiming for primary completion of the study during the fourth calendar quarter of 2023.
At this time, the clinical team will enter final data into the electronic data system, resolve any outstanding queries, and begin the cleaning process leading to database lock, BioVie said.
BioVie is a clinical-stage company developing innovative therapies to overcome unmet medical needs in chronic debilitating conditions.
Contact the author at emily.jarvie@proactiveinvestors.com
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