BioVie Announces Alignment with FDA on Clinical Trial to Assess Bezisterim in Parkinson’s Disease
BioVie Inc. (NASDAQ: BIVI) has announced alignment with the FDA for its SUNRISE-PD trial to evaluate bezisterim (NE3107) in Parkinson's disease. The trial will assess the drug's effect on motor and non-motor symptoms in approximately 60 patients naive to carbidopa/levodopa. The FDA recommended including the MDS-UPDRS Part II score as a primary endpoint, which is already part of the trial design as a secondary endpoint. BioVie plans to initiate patient screening in Q4 2024. This Phase 2 study aims to explore bezisterim's impact on newly diagnosed patients, complementing earlier trials and potentially establishing its applicability for the entire Parkinson's patient population.
BioVie Inc. (NASDAQ: BIVI) ha annunciato un allineamento con la FDA per il suo trial SUNRISE-PD per valutare il bezisterim (NE3107) nella malattia di Parkinson. Lo studio valuterà l'effetto del farmaco sui sintomi motori e non motori in circa 60 pazienti naif rispetto al carbidopa/levodopa. La FDA ha raccomandato di includere il punteggio MDS-UPDRS Parte II come endpoint primario, già previsto nel design dello studio come endpoint secondario. BioVie prevede di iniziare lo screening dei pazienti nel Q4 2024. Questo studio di fase 2 mira a esplorare l'impatto del bezisterim sui pazienti recentemente diagnosticati, completando le prove precedenti e potenzialmente stabilendo la sua applicabilità per l'intera popolazione di pazienti affetti da Parkinson.
BioVie Inc. (NASDAQ: BIVI) ha anunciado una alineación con la FDA para su ensayo SUNRISE-PD para evaluar el bezisterim (NE3107) en la enfermedad de Parkinson. El ensayo evaluará el efecto del fármaco en los sintomas motores y no motores en aproximadamente 60 pacientes naïve a carbidopa/levodopa. La FDA recomendó incluir el puntuación MDS-UPDRS Parte II como un resultado primario, que ya forma parte del diseño del ensayo como un resultado secundario. BioVie planea iniciar el cribado de pacientes en el cuarto trimestre de 2024. Este estudio de fase 2 tiene como objetivo explorar el impacto del bezisterim en pacientes recién diagnosticados, complementando ensayos anteriores y potencialmente estableciendo su aplicabilidad para toda la población de pacientes con Parkinson.
BioVie Inc. (NASDAQ: BIVI)는 파킨슨병에서 bezisterim(NE3107)을 평가하기 위한 SUNRISE-PD 시험에 대해 FDA와의 조정을 발표했습니다. 이 시험은 카비도파/레보도파에 경험이 없는 약 60명의 환자를 대상으로 약물의 운동 및 비운동 증상에 대한 영향을 평가합니다. FDA는 MDS-UPDRS Part II 점수를 주요 평가지표로 포함할 것을 권장했으며, 이는 시험 설계에서 이미 보조 평가지표로 포함되어 있습니다. BioVie는 2024년 4분기에 환자 선별을 시작할 계획입니다. 이 2상 연구는 새로 진단된 환자에서 bezisterim의 영향을 탐색하는 것을 목표로 하며, 이전 임상시험을 보완하고 잠재적으로 전체 파킨슨병 환자군에 대한 적용 가능성을 확립할 수 있습니다.
BioVie Inc. (NASDAQ: BIVI) a annoncé un alignement avec la FDA pour son essai SUNRISE-PD visant à évaluer le bezisterim (NE3107) dans la maladie de Parkinson. L'essai examinera l'effet du médicament sur les symptômes moteurs et non moteurs chez environ 60 patients naïfs de carbidopa/levodopa. La FDA a recommandé d'inclure le score MDS-UPDRS Partie II comme un critère principal, ce qui fait déjà partie de la conception de l'essai en tant que critère secondaire. BioVie prévoit de débuter le dépistage des patients au quatrième trimestre 2024. Cette étude de phase 2 vise à explorer l'impact du bezisterim chez les patients nouvellement diagnostiqués, complétant des essais antérieurs et établissant potentiellement son applicabilité pour l'ensemble de la population des patients atteints de Parkinson.
BioVie Inc. (NASDAQ: BIVI) hat eine Einigung mit der FDA für die SUNRISE-PD Studie zur Evaluation von bezisterim (NE3107) bei Parkinson-Krankheit bekannt gegeben. Die Studie wird die Wirkung des Medikaments auf motorische und nicht-motorische Symptome bei etwa 60 Patienten untersuchen, die bisher nicht mit Carbidopa/Levodopa behandelt wurden. Die FDA empfahl, den MDS-UPDRS Teil II Score als primären Endpunkt aufzunehmen, der bereits als sekundärer Endpunkt Teil des Studienplans ist. BioVie plant, im vierten Quartal 2024 mit dem Patientenscreening zu beginnen. Diese Phase-2-Studie zielt darauf ab, die Auswirkungen von bezisterim bei neu diagnostizierten Patienten zu untersuchen, um frühere Studien zu ergänzen und möglicherweise die Anwendbarkeit für die gesamte Parkinson-Patientenpopulation zu etablieren.
- Alignment achieved with FDA on SUNRISE-PD trial design
- No protocol amendments required, allowing the trial to proceed as planned
- Potential to establish bezisterim's applicability for the total Parkinson's patient population
- Previous Phase 2a trial showed promising results in improving motor control
- Patient screening not set to begin until Q4 2024, indicating a lengthy timeline for trial completion and potential market entry
Insights
The FDA's alignment on BioVie's SUNRISE-PD trial for bezisterim in Parkinson's disease is a significant milestone. The agency's recommendation to include the MDS-UPDRS Part II score as a primary endpoint strengthens the trial's design, potentially expediting the path to registration. This alignment suggests the FDA sees merit in BioVie's approach, which could be positive for investor confidence.
The trial's focus on newly diagnosed, treatment-naïve patients is strategically important. If successful, it could position bezisterim as a first-line treatment option, potentially capturing a larger market share. The Q4 2024 timeline for patient screening indicates a well-planned development strategy, although investors should note that clinical trials often face delays.
While promising, it's important to remember that Phase 2 results are not guaranteed to translate to Phase 3 success. Investors should monitor for updates on patient recruitment and any interim data releases, as these will be critical in assessing bezisterim's potential in the competitive Parkinson's disease market.
BioVie's bezisterim (NE3107) represents an intriguing approach to Parkinson's disease treatment. The focus on both motor and non-motor symptoms in treatment-naïve patients is particularly noteworthy. If successful, this could address a significant unmet need in early-stage PD management.
The inclusion of the MDS-UPDRS Part II score as a primary endpoint is crucial. This measure focuses on motor experiences of daily living, which directly impact patients' quality of life. A positive outcome here could differentiate bezisterim from existing therapies that primarily target motor symptoms.
The previous Phase 2a results suggesting improved motor control when combined with levodopa are promising. However, the true test will be bezisterim's performance as a standalone therapy in treatment-naïve patients. If it can delay the need for levodopa initiation or provide better symptom control, it could potentially alter the treatment paradigm for early-stage Parkinson's disease.
SUNRISE-PD to evaluate the effect of bezisterim (NE3107) on motor and non-motor symptoms in ~60 patients with Parkinson’s disease who are naïve to carbidopa/levodopa
Company engaged in trial start-up activities and plans to initiate patient screening Q4 2024
CARSON CITY, Nev., Aug. 08, 2024 (GLOBE NEWSWIRE) -- BioVie Inc., (NASDAQ: BIVI) (“BioVie” or the “Company”) a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease, today announced that it has achieved alignment with the Food and Drug Administration (FDA) on its upcoming SUNRISE-PD trial in Parkinson’s disease (“PD”). As a result, the Company is conducting trial start-up activities with a view to initiate patient screening in Q4 2024.
The Company submitted the SUNRISE-PD clinical trial protocol to the FDA for comments, and the agency provided a single, actionable comment recommending the inclusion of the Part II score from the Movement Disorder Society’s Unified Parkinson’s Disease Rating Scale (“MDS-UPDRS”) as a primary endpoint for potential future registrational filings. As this metric is already included as a secondary endpoint within the current trial design, BioVie believes it can proceed with the SUNRISE-PD trial as planned without protocol amendments.
"The SUNRISE-PD trial focuses on the second of two objectives we have in developing bezisterim for Parkinson’s disease, which is to improve upon the motor experiences in patients’ daily living,” said Cuong Do, BioVie’s President and CEO. “Our Phase 2a trial demonstrated that bezisterim in conjunction with levodopa may dramatically improved motor control for patients with moderate to severe symptoms of Parkinson’s disease. The Phase 2 SUNRISE-PD trial is designed to explore bezisterim’s impact on symptoms of Parkinson’s disease in patients who need medication for the first time. This Phase 2 study intends to address the newly diagnosed patient population, which in conjunction with our earlier trial, could establish bezisterim’s applicability for the total Parkinson’s patient population and provide a foundation for a disease progression study, which is the ultimate objective of the PD program. We are currently engaged in trial start up preparations, and hope to initiate patient screening in Q4 of 2024."
About the SUNRISE-PD Trial in Early Parkinson’s Disease
SUNRISE-PD is a Phase 2, multicenter, randomized, double-blind, placebo-controlled trial with a hybrid decentralized design that will last 20 weeks from the initial screening phase to the safety follow up. During the 12-week double-blind phase, around 60 patients will be randomized 1:1 to receive either 20 mg of bezisterim (NE3107), or placebo twice-daily.
As part of the trial, patients may participate either completely from their home or at a clinical site. At-home participants will be visited by study nurses who will complete study assessments with the assistance of a neurologist who will attend the visit remotely by video and supervise administration of a modified MDS-UPDRS Part III examination, which will be recorded for review and scoring by a central rating committee. If the trial's results are positive, participants may be eligible to enter a longer-term, open-label safety study.
About Bezisterim
Bezisterim (NE3107) is an orally bioavailable, BBB-permeable, insulin-sensitizer that is also anti-inflammatory. In addition, it is not immunosuppressive and has a low risk of drug-to-drug interaction. Bezisterim has the potential to reduce symptoms of long COVID, including fatigue and cognitive dysfunction. Persistently circulating viral spike proteins are believed to trigger TLR-4 driven activation of NF-κB and the subsequent expression of inflammatory cytokines (IL-6, TNF, IFNg). Bezisterim has been shown to modulate the activation of NF-κB and thus modulate inflammation.
Bezisterim is being investigated for Alzheimer’s disease (AD) and Parkinson’s disease (PD). BioVie has conducted and reported efficacy data on its Phase 3 randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate bezisterim in patients who have mild-to-moderate AD (NCT04669028). Results of a Phase 2 investigator-initiated trial (NCT05227820) showing bezisterim-treated patients experienced improved cognition and biomarker levels were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) annual conference in December 2022. An estimated six million Americans suffer from AD. A Phase 2 study of bezisterim in PD (NCT05083260) has been completed, and data presented at the AD/PD™ 2023 International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders in Gothenburg, Sweden in March 2023 showed significant improvements in “morning on” symptoms and clinically meaningful improvement in motor control in patients treated with a combination of bezisterim and levodopa vs. patients treated with levodopa alone, and no drug-related adverse events.
About BioVie Inc.
BioVie Inc. (NASDAQ: BIVI) is a clinical-stage company developing innovative drug therapies for the treatment of neurological and neurodegenerative disorders and advanced liver disease. In neurodegenerative disease, the Company’s drug candidate bezisterim inhibits inflammatory activation of ERK and NFkB (e.g., TNF signaling) that leads to neuroinflammation and insulin resistance, but not their homeostatic functions (e.g., insulin signaling and neuron growth and survival). Both are drivers of AD and PD. In liver disease, the Company’s Orphan drug candidate BIV201 (continuous infusion terlipressin), with U.S. Food and Drug Administration (“FDA”) Fast Track status, is being evaluated and discussed with guidance received from the FDA regarding the design of Phase 3 clinical testing of BIV201 for the treatment of ascites due to chronic liver cirrhosis. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis. For more information, visit www.bioviepharma.com.
Forward-Looking Statements
This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law.
For Investor Relations Inquiries:
Contact:
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
For Media Inquires
Melyssa Weible
Managing Partner, Elixir Health Public Relations
Ph: +1 201-723-5705
mweible@elixirhealthpr.com
FAQ
What is the purpose of BioVie's SUNRISE-PD trial for bezisterim (NE3107)?
When does BioVie (BIVI) plan to start patient screening for the SUNRISE-PD trial?
What recommendation did the FDA make for BioVie's SUNRISE-PD trial?
How does the SUNRISE-PD trial fit into BioVie's overall development plan for bezisterim in Parkinson's disease?
