Firefly Neuroscience Announces Use of Its Brain Network Analytics Platform in Phase 1 Study of SP-624, the First Potential Treatment Designed for Women with Major Depressive Disorder
Firefly Neuroscience (NASDAQ: AIFF) announced that its FDA-510(k) cleared Brain Network Analytics (BNA™) biomarker discovery AI platform will support Arrivo Bioventures' Phase 1 exploratory study of SP-624, a first-in-class SIRT6 activator for major depressive disorder (MDD). The study will evaluate SP-624's impact on neurological pathways and cognitive domains in healthy volunteers and MDD patients.
SP-624 is also being studied in a large Phase 2b trial, focusing on efficacy in females. In a previous Phase 2 study, SP-624 showed statistically significant improvement versus placebo in female subjects with MDD, but not in males. Firefly's BNA™ technology aims to identify target engagement and biomarkers for future neurological studies, potentially addressing the unmet medical need in women's mental health.
Firefly Neuroscience (NASDAQ: AIFF) ha annunciato che la sua piattaforma di scoperta di biomarcatori AI Brain Network Analytics (BNA™) approvata dalla FDA-510(k) supporterà lo studio esplorativo di Fase 1 di Arrivo Bioventures su SP-624, un attivatore SIRT6 di prima classe per il disturbo depressivo maggiore (MDD). Lo studio valuterà l'impatto di SP-624 sulle vie neurologiche e sui domini cognitivi in volontari sani e pazienti con MDD.
SP-624 è anche oggetto di uno studio di Fase 2b di grandi dimensioni, focalizzato sull'efficacia nelle donne. In uno studio precedente di Fase 2, SP-624 ha dimostrato un miglioramento statisticamente significativo rispetto al placebo nelle soggette femminili con MDD, ma non nei maschi. La tecnologia BNA™ di Firefly mira a identificare l'impegno dei target e i biomarcatori per futuri studi neurologici, potenzialmente affrontando il bisogno medico insoddisfatto nella salute mentale femminile.
Firefly Neuroscience (NASDAQ: AIFF) anunció que su plataforma de descubrimiento de biomarcadores AI Brain Network Analytics (BNA™) aprobada por la FDA-510(k) apoyará el estudio exploratorio de Fase 1 de Arrivo Bioventures sobre SP-624, un activador SIRT6 de primera clase para el trastorno depresivo mayor (MDD). El estudio evaluará el impacto de SP-624 en las vías neurológicas y en los dominios cognitivos en voluntarios sanos y pacientes con MDD.
SP-624 también se está estudiando en un gran ensayo de Fase 2b, centrado en la eficacia en mujeres. En un estudio anterior de Fase 2, SP-624 mostró mejoras significativamente estadísticas en comparación con el placebo en sujetos femeninos con MDD, pero no en hombres. La tecnología BNA™ de Firefly tiene como objetivo identificar el compromiso de los objetivos y los biomarcadores para futuros estudios neurológicos, abordando potencialmente la necesidad médica no satisfecha en la salud mental de las mujeres.
Firefly Neuroscience (NASDAQ: AIFF)는 FDA-510(k) 승인을 받은 Brain Network Analytics (BNA™) 바이오마커 발견 AI 플랫폼이 Arrivo Bioventures의 SP-624에 대한 1상 탐색 연구를 지원할 것이라고 발표했습니다. SP-624는 주요 우울 장애 (MDD)를 위한 최초의 SIRT6 활성제입니다. 이 연구는 건강한 자원봉사자와 MDD 환자에서 SP-624의 신경 경로 및 인지 영역에 미치는 영향을 평가할 것입니다.
SP-624는 여성의 효능에 중점을 둔 대규모 2b상 시험에서도 연구되고 있습니다. 이전의 2상 연구에서 SP-624는 MDD를 앓고 있는 여성 피험자에서 플라시보에 비해 통계적으로 유의미한 개선 효과를 보였습니다, 그러나 남성에서는 그렇지 않았습니다. Firefly의 BNA™ 기술은 미래의 신경학적 연구를 위한 타겟 참여 및 바이오마커를 식별하는 것을 목표로 하며, 여성 정신 건강에서 충족되지 않은 의학적 필요를 해결할 수 있는 가능성이 있습니다.
Firefly Neuroscience (NASDAQ: AIFF) a annoncé que sa plateforme d'IA pour la découverte de biomarqueurs, Brain Network Analytics (BNA™), approuvée par la FDA-510(k) soutiendra l'étude exploratoire de Phase 1 d'Arrivo Bioventures sur SP-624, un activateur SIRT6 de première classe pour le trouble dépressif majeur (MDD). L'étude évaluera l'impact de SP-624 sur les voies neurologiques et les domaines cognitifs chez des volontaires sains et des patients atteints de MDD.
SP-624 est également à l'étude dans un grand essai de Phase 2b, axé sur l'efficacité chez les femmes. Dans une étude précédente de Phase 2, SP-624 a montré une amélioration statistiquement significative par rapport au placebo chez les sujets féminins atteints de MDD, mais pas chez les hommes. La technologie BNA™ de Firefly vise à identifier l'engagement des cibles et les biomarqueurs pour de futures études neurologiques, abordant potentiellement le besoin médical non satisfait dans la santé mentale des femmes.
Firefly Neuroscience (NASDAQ: AIFF) gab bekannt, dass ihre von der FDA-510(k) zugelassene KI-Plattform zur Entdeckung von Biomarkern, Brain Network Analytics (BNA™), die Phase-1-Explorationsstudie von Arrivo Bioventures zu SP-624, einem erstklassigen SIRT6-Aktivator für major depressive disorder (MDD), unterstützen wird. Die Studie wird die Auswirkungen von SP-624 auf neurologische Wege und kognitive Bereiche bei gesunden Probanden und MDD-Patienten bewerten.
SP-624 wird auch in einer großen Phase-2b-Studie untersucht, die sich auf die Wirksamkeit bei Frauen konzentriert. In einer vorherigen Phase-2-Studie zeigte SP-624 statistisch signifikante Verbesserungen gegenüber dem Placebo bei weiblichen Probanden mit MDD, jedoch nicht bei Männern. Die BNA™-Technologie von Firefly zielt darauf ab, die Zielinteraktion und Biomarker für zukünftige neurologische Studien zu identifizieren, um potenziell den ungedeckten medizinischen Bedarf im Bereich der weiblichen psychischen Gesundheit zu adressieren.
- FDA-510(k) cleared Brain Network Analytics (BNA™) platform being used in Phase 1 study
- SP-624 showed statistically significant improvement vs placebo in female MDD patients in previous Phase 2 study
- Potential for biomarker discovery to inform future neurological research
- Addressing unmet medical need in women's mental health
- No statistically significant changes detected in male subjects in previous SP-624 study
Insights
This study represents a significant step in developing targeted treatments for women with major depressive disorder (MDD), addressing a critical unmet need in mental health. The use of Firefly's BNA™ technology in Arrivo's Phase 1 study of SP-624 is particularly noteworthy for several reasons:
- It aims to identify biomarkers that could inform future research across various neurological conditions, potentially accelerating drug development.
- The focus on gender-specific efficacy is innovative, as previous results showed statistically significant improvement in female subjects but not in males.
- The exploration of SIRT6 activation as a mechanism for treating MDD aligns with emerging research on epigenetic factors in neuropsychiatric disorders.
However, it's important to note that this is an early-stage study and the full impact on Firefly's business will depend on the success of the trial and subsequent development stages. The potential for broader applications of the BNA™ platform in neurological research could significantly enhance Firefly's market position if positive results are achieved.
Study to Leverage Firefly’s BNA™ Technology for Biomarker Identification, with Potential Applications for Broader Neurological Research
TORONTO, Oct. 15, 2024 (GLOBE NEWSWIRE) -- Firefly Neuroscience, Inc. (“Firefly,” or the “Company”) (NASDAQ: AIFF), an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders, today announced that its FDA-510(k) cleared Brain Network Analytics (BNA™) biomarker discovery AI platform will be used to support Arrivo Bioventures’ (“Arrivo”) Phase 1 exploratory study of its first-in-class SIRT6 activator, SP-624, in healthy volunteers and patients with major depressive disorder (MDD).
The study, which has enrolled its first subject, is designed to evaluate the impact of the epigenetic mechanism of action of SP-624 on neurological pathways and assess changes in various cognitive domains. SP-624 is also currently being studied in a large Phase 2b study in patients diagnosed with MDD, with efficacy in females as the primary endpoint.
“We believe that utilizing Firefly’s BNA™ technology in the SP-624 study will help Arrivo better understand SP-624’s activity and uncover critical biomarkers that may inform future research across neurological conditions,” said Jon Olsen, CEO of Firefly. “Together with Arrivo, this study underscores our shared commitment to advancing targeted treatments for women with major depressive disorder, which continues to be an unmet medical need in mental health.”
In an earlier Phase 2 study of SP-624, Arrivo explored efficacy over placebo during a four week treatment period. In a post-hoc analysis, the company found statistically significant improvement versus placebo consistent across both investigator and patient measures of MDD in female subjects, which was achieved as early as week 2. In male subjects, there were no statistically significant changes detected. While differences in MDD between males and females have long been discussed, these results support recent published literature citing differences in gene expression between males and females with MDD. Using Firefly’s BNA™ technology, Arrivo will also identify target engagement and biomarkers in the Phase 1 study that can be used in future studies across a variety of neurological conditions, including MDD.
“There is a growing body of literature suggesting that targeting SIRT6 can play an important role in multiple neuropsychiatric, neurodegenerative, inflammatory, and metabolic diseases,” said Steve Butts, CEO of Arrivo. “This study should help us in our ongoing efforts to characterize the activity of SP-624 and look for potential biomarkers.”
The Phase 1, single-center, double-blind, randomized, placebo-controlled study is being conducted at Alivation Research with Walt Duffy, M.D., founder, CEO and Chief Medical Officer, as the Principal Investigator.
About Firefly
Firefly (NASDAQ: AIFF) is an Artificial Intelligence (“AI”) company developing innovative solutions that improve brain health outcomes for patients with neurological and mental disorders. Firefly’s FDA-510(k) cleared Brain Network Analytics (BNA™) technology revolutionizes diagnostic and treatment monitoring methods for conditions such as depression, dementia, anxiety disorders, concussions, and ADHD. Over the past 15 years, Firefly has built a comprehensive database of brain wave tests, securing patent protection, and achieving FDA clearance. The Company is now launching BNA™ commercially, targeting pharmaceutical companies engaged in drug research and clinical trials, as well as medical practitioners for clinical use.
Brain Network Analytics was developed using artificial intelligence and machine learning on Firefly’s extensive proprietary database of standardized, high-definition longitudinal electroencephalograms (EEGs) of over 17,000 patients representing twelve disorders, as well as clinically normal patients. BNA™, in conjunction with an FDA-cleared EEG system, can provide clinicians with comprehensive insights into brain function. These insights can enhance a clinician’s ability to accurately diagnose mental and cognitive disorders and to evaluate what therapy and/or drug is best suited to optimize a patient’s outcome.
Please visit https://fireflyneuro.com/ for more information.
About Arrivo BioVentures
Arrivo BioVentures is propelled forward by its insatiable curiosity and drive to solve complex problems and help millions of patients globally. Working in partnership with investors, innovators, and pharmaceutical companies, Arrivo is always seeking solutions for unmet medical needs. Arrivo has a portfolio of diverse drug candidates with the potential to be first-in-class or best-in-class. Arrivo is based in Morrisville, N.C., on the edge of Research Triangle Park. For more information, visit www.arrivobio.com.
Forward-Looking Statements
Certain statements in this press release and the information incorporated herein by reference may constitute “forward-looking statements” for purposes of the federal securities laws concerning Firefly. These forward-looking statements include express or implied statements relating to Firefly’s management teams’ expectations, hopes, beliefs, intentions, or strategies regarding the future. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. The words “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements are based on current expectations and beliefs concerning future developments and their potential effects. There can be no assurance that future developments affecting Firefly will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond Firefly’s control) or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to development and commercialization of BNA™ technology; risks related to Firefly’s ability to recognize the anticipated benefits of the merger (the “Merger”) with WaveDancer, Inc. (“WaveDancer”); risks related to Firefly’s ability to correctly estimate its operating expenses and expenses associated with the Merger and other events and unanticipated spending and costs that could reduce Firefly’s cash resources; the ability of Firefly to protect its intellectual property rights; competitive responses to the business combination; unexpected costs, charges or expenses resulting from the Merger; potential adverse reactions or changes to business relationships resulting from the completion of the Merger; legislative, regulatory, political and economic developments; and those factors described under the heading “Risk Factors” in the in the registration statement on Form S-4 filed by WaveDancer with the Securities and Exchange Commission on January 22, 2024, as amended, and declared effective on February 6, 2024. Should one or more of these risks or uncertainties materialize, or should any of Firefly’s assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. It is not possible to predict or identify all such risks. Forward-looking statements included in this press release only speak as of the date they are made, and Firefly does not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Arrivo Bio Media Contact
ICR Healthcare
Alexis Feinberg, Vice President
Alexis.feinberg@westwicke.com
Firefly Neuroscience Investor Contacts
KCSA Strategic Communications
Valter Pinto / Jack Perkins
(212) 896-1254
Firefly@KCSA.com
Firefly Neuroscience Media Contact
KCSA Strategic Communications
Raquel Cona, Vice President
(516) 779-2630
Rcona@KCSA.com
FAQ
What is the purpose of Firefly Neuroscience's BNA™ platform in the SP-624 study?
What were the results of the previous Phase 2 study of SP-624 for MDD?
How is Firefly Neuroscience (NASDAQ: AIFF) addressing the gender differences in MDD treatment?
What is the current status of SP-624 clinical trials for MDD?
