BioVie Launches SUNRISE-PD Study for Early Parkinson’s Care
The SUNRISE-PD trial investigates bezisterim’s potential benefits in patients with early-stage Parkinson's disease.
This innovative approach incorporates options for remote patient participation, enhancing access for those in need.
Enrollment is underway, supported by well-known foundations focused on Parkinson's disease advocacy.
The results from this study are expected to shed new light on treatment advancements around 2025 or 2026.
CARSON CITY, Nev. — BioVie Inc. (NASDAQ: BIVI), a clinical-stage company dedicated to developing breakthrough therapies for various neurological disorders, has officially begun patient enrollment for its Phase 2 SUNRISE-PD clinical trial. This important study is aimed at assessing the safety and efficacy of bezisterim (NE3107) in treating both motor and non-motor symptoms in patients with Parkinson’s disease who have yet to receive traditional treatments like carbidopa/levodopa. The trial has already welcomed its first participant.
Parkinson’s disease is a progressively debilitating neurodegenerative condition, often marked by symptoms such as muscle rigidity, tremors, and slowed movement. Current treatments primarily serve to alleviate symptoms rather than alter the disease's course, which can be devastating for patients and their families.
“Our earlier Phase 2a trial provided promising insights into bezisterim’s potential in managing advanced Parkinson’s symptoms,” commented Cuong Do, President and CEO of BioVie. “With SUNRISE-PD, we are eager to examine its effects at an earlier disease stage, focusing on patients initiating therapy. This trial, notably, allows for remote participation through decentralized sites, expanding accessibility for participating patients.”
Designed as a Phase 2b, multicenter, randomized, double-blind, placebo-controlled trial, SUNRISE-PD will span 20 weeks. Within the double-blind segment lasting 12 weeks, around 60 patients will be allocated in a 1:1 ratio to receive either 20 mg of bezisterim or a placebo twice daily.
Participants can opt to engage fully from home or receive care at clinical sites. For those participating from home, study nurses will conduct evaluations and assistance, while neurologists will supervise through video conferencing to ensure protocol adherence and accurate assessments. If successful, participants may also qualify for a long-term, open-label follow-up study.
“Research has increasingly shown that chronic inflammation and insulin resistance are pivotal to both the onset and progression of Parkinson’s disease,” explained Dr. Mark Stacy, Neurology Professor at the Medical University of South Carolina and an advisor for the SUNRISE-PD trial. “Bezisterim could offer a novel therapeutic approach that diverges from conventional therapies that often introduce complications, enhancing treatment outcomes.”
The SUNRISE-PD trial aligns with the Parkinson’s Foundation's mission of increasing access to clinical trials. Chief Scientific Officer, James Beck, emphasized the importance of remote trial participation, stating that this approach can significantly lower geographical barriers preventing those living with Parkinson's from obtaining crucial treatment opportunities.
BioVie announced earlier that funding for the SUNRISE-PD trial is secured, bolstered by collaboration with prominent advocacy organizations like the Michael J. Fox Foundation and the Davis Phinney Foundation. Patients recently diagnosed with Parkinson's who haven’t begun dopamine-replacement therapy might qualify for enrollment. More details are available at www.sunrisePD.com.
Understanding Parkinson’s Disease
Parkinson’s disease is a neurodegenerative disorder profoundly impacting motor function due to dopamine neuron loss in the brain. It is characterized by tremors, rigidity, and bradykinesia, along with significant non-motor symptoms such as mood disorders and cognitive decline. Early symptoms can be subtle but tend to escalate as the disease progresses, eventually necessitating comprehensive care.
Since the recognition of dopamine's role in Parkinson's treatment in the 1960s, levodopa has been pivotal in symptom management. However, prolonged use typically leads to complications like motor fluctuations and involuntary movements, raising the demand for innovative therapies.
Current findings emphasize the negative implications of chronic inflammation and insulin resistance in Parkinson’s disease. Neuroinflammation and disrupted glucose regulation contribute to neuronal degeneration, fostering a cycle that aggravates symptom progression. Anti-inflammatory and insulin-sensitizing therapies like bezisterim present promising avenues for treatment innovations.
The Role of Bezisterim
Bezisterim (NE3107) is an orally bioavailable drug known for its anti-inflammatory and insulin-sensitizing properties. It is designed to interact selectively with cellular pathways, potentially offering substantial improvements in various conditions, including Parkinson’s disease.
BioVie has previously reported positive findings from its Phase 3 studies regarding bezisterim’s impact on Alzheimer’s patients, capturing significant cognitive improvements alongside safety assurances. Given its adaptable design, bezisterim shows great promise for patients across multiple neurodegenerative conditions.
With the increasing prevalence of long COVID, research is also exploring how bezisterim could alleviate neurological symptoms, providing further beneficial applications for this innovative therapy.
About BioVie Inc.
BioVie Inc. (NASDAQ: BIVI) focuses on formulating pioneering drug therapies against neurological and neurodegenerative diseases, including Parkinson’s, Alzheimer’s, and complications of advanced liver disease. Its drug candidate bezisterim aims at inhibiting neuroinflammation and enhancing insulin sensitivity while preserving vital cellular functions. The company is also advancing its Orphan drug candidate, BIV201, designed for liver disease treatment.
For further information, visit www.bioviepharma.com.
Frequently Asked Questions
What is the SUNRISE-PD trial about?
The SUNRISE-PD trial evaluates the efficacy of bezisterim for treating early-stage Parkinson’s disease, focusing on its safety and potential benefits for patients.
Who is eligible to participate in the SUNRISE-PD trial?
Patients newly diagnosed with Parkinson’s disease who have not yet started treatment with levodopa or similar medications may qualify for the trial.
What makes the SUNRISE-PD trial unique?
This trial incorporates a decentralized approach allowing patients to participate remotely, broadening access and convenience for participants.
What are the main symptoms of Parkinson’s disease?
Key symptoms of Parkinson’s disease include tremors, muscle rigidity, bradykinesia, and challenges with balance and speech, also affecting non-motor functions like mood and cognition.
How does bezisterim work?
Bezisterim is designed to target underlying inflammation and insulin resistance in the brain, representing a potential new treatment strategy for neurodegenerative diseases.
