BioVie aims to treat Parkinson’s and Alzheimer’s by focusing on inflammation

By targeting inflammation as a novel pathway, clinical-stage biotechnology company BioVie Inc (NASDAQ:BIVI) aims to discover treatments for neurological and neurodegenerative disorders and advanced liver disease. 

As BioVie CEO Cuong Do told Proactive, the company's purpose is to create new solutions that enable people to live healthier lives as they age. “Everything BioVie does is centred on this purpose,” Do said. 

Setting it apart from other biotechs working towards treatments for Alzheimer’s disease and Parkinson’s disease is BioVie's focus on inflammation which occurs as part of the body’s natural protective processes. 

“While both treatment areas are receiving plenty of attention right now, BioVie is one of only a small handful of companies even considering inflammation as the primary target for reducing symptoms in those two diseases,” Do said. 

“Over the years, research has discovered clear links between inflammation and aging and uncovered the critical role inflammation plays in neurological aging-related diseases like Alzheimer’s and Parkinson's.

“As a result of all this research, we've come to recognize that inflammation is the root cause of many health problems, including many not traditionally thought to be inflammatory.” 

‘Promising’ clinical results to date for NE3107  

BioVie’s focus is on its drug candidate for Alzheimer’s and Parkinson’s, NE3107, with the aim of reducing inflammation in the two conditions.

NE3107 is a synthetic analogue of a metabolite of the adrenal hormone DHEA. As Do told Proactive, NE3107 targets the master regulator of inflammation TNFα. 

“Studies have shown that NE3107 reduced the production of TNFα and thus inflammation,” he said. “These same studies showed that by reducing inflammation, NE3107 also reduces insulin resistance and oxidative stress, both common features in neurodegenerative diseases like Alzheimer's and Parkinson's.”

Do explained that two conditions must be present at the same time for an individual to develop Parkinson’s symptoms: low dopamine levels in the brain and inflammation and associated insulin resistance. 

“If a person has low dopamine but not insulin resistance, that person does not develop Parkinson’s symptoms,” he said. 

“Since nothing has been available to address the inflammation and insulin resistance component, clinicians are left with only the option of increasing the dopamine levels with the use of the drug levodopa. NE3107 hopes to address inflammation and insulin resistance components and thus allow the body to continue to use the amount of dopamine naturally there in the brain.”

To date, BioVie’s clinical trials for NE3107 in both Alzheimer’s and Parkinson’s have been quite promising, Do noted. 

In its Phase 2 trial for patients with Mild Cognitive Impairment or pre-Alzheimer’s and mild Alzheimer’s, those treated with NE3107 experienced a reversal of cognitive decline and improvements in abnormal brain imaging scans. 

“Furthermore, we finished enrolling patients in our Phase 3 trial of NE3107 in mild- to moderate-Alzheimer's in February, which puts this trial on a schedule to provide top-line data read-out in the October/November 2023 timeframe,” Do said. 

He continued: “Our Phase 2 trial in Parkinson's showed that significantly more patients treated with NE3107 experienced the 'on state' in the morning, meaning they had fewer symptoms and were able to get out of bed in the morning presumably because their NE3107’s intrinsic pro-motoric whereas those treated with just the standard of care medication could not because the drug effect wore off overnight while they slept.”

Due to the unmet need for both of these diseases, there is significant commercial potential for BioVie should it succeed in gaining regulatory approval for NE3107. The company estimates that in the US alone it could generate $30 billion in annual sales for every 1 million people treated, and for Parkinson’s $3 billion in annual sales for every 100,000 individuals treated. 

The company is also resuming discovery research to explore additional molecules and indications, such as NE3107’s sister molecule HE3291, which has a similar activity profile to NE3107. BioVie intends to communicate its research focus in due course. 

BIV201 for liver disease

The company also has a drug candidate in development for ascites, a condition characterized by fluid build-up in the abdomen which usually occurs as a complication of the liver disease cirrhosis. 

Currently, no pharmacological treatments are approved for ascites, which has a greater than 40% mortality rate in 12 months. 

BioVie’s drug candidate BIV201 targets the pathophysiology of ascites. The company recently paused patient enrollment for its Phase 2 trial on BIV201 for ascites because it has already demonstrated the ability to significantly reduce ascites fluid build-up. 

During the trial, patients treated with BIV201 experienced a 37% reduction in ascites fluid reduction compared to the standard of care. There was a 53% reduction in ascites volume in patients who completed the BIV201 treatment and patients who started but did not complete the treatment saw a 15% decrease, while patients receiving the standard of care saw a 3.1% increase in ascites volume. 

The company is engaging with the US Food and Drug Administration (FDA) on the next steps for BIV201. 

“Given the high unmet medical needs and the positive data, we believe it’s in patients’ best interest to stop the study early and engage the FDA in discussions on how to advance to the Phase 3 pivotal registrational trial,” Do said. 

What’s to come from BioVie 

Do believes BioVie has the most exciting portfolio in biotech with many Phase 3 trials expected to provide data readouts in the next 12-to-18 months. 

“We have a series of presentations providing additional Alzheimer’s and Parkinson’s data at a number of upcoming scientific conferences,” he said. 

“We will initiate potentially pivotal Phase 2b/3 trials for Alzheimer’s and Parkinson’s and everyone is eagerly awaiting the topline data from our pivotal Phase 3 trial in Alzheimer’s in the October/November timeframe.” 

In terms of commercialization, BioVie said it is open to all options, including partnerships. The Carson City, Nevada-based biotech revealed that it has engaged in initial conversations with intrigued parties who are awaiting the Phase 3 Alzheimer’s trial data readout. 

Contact the author at emily.jarvie@proactiveinvestors.com

Follow her on Twitter @emilyjjarvie