Firefly Neuroscience Collaborates with Bright Minds Biosciences to Analyze the Data from its Positive Phase 1 Study using its Artificial Intelligence, FDA-Cleared BNA™ Technology
Firefly Neuroscience (NASDAQ: AIFF) has announced a collaboration with Bright Minds Biosciences to analyze data from Bright Minds' positive Phase 1 study using Firefly's AI-powered BNA™ technology. The study focused on Bright Minds' lead compound, BMB-101, and utilized EEG headsets provided by Firefly's partner, Zeto.
The qEEG data analysis demonstrated positive results, with EEG recordings taken at multiple timepoints during the study. Firefly's advanced EEG analysis platform was used to process the data. Jon Olsen, CEO of Firefly, highlighted the value of their AI platform for clinical studies, while Ian McDonald, CEO of Bright Minds, stated that the results validate their approach and indicate that BMB-101 is achieving brain penetration as predicted.
With the completion of this Phase 1 study, BMB-101 is now considered a Phase 2 ready asset, and Bright Minds plans to move forward with an investigative new drug submission.
Firefly Neuroscience (NASDAQ: AIFF) ha annunciato una collaborazione con Bright Minds Biosciences per analizzare i dati del positivo studio di Fase 1 di Bright Minds, utilizzando la tecnologia BNA™ alimentata dall'AI di Firefly. Lo studio si è concentrato sul composto principale di Bright Minds, BMB-101, e ha utilizzato cuffie EEG fornite dal partner di Firefly, Zeto.
L'analisi dei dati qEEG ha dimostrato risultati positivi, con registrazioni EEG effettuate in più momenti durante lo studio. La piattaforma avanzata di analisi EEG di Firefly è stata impiegata per elaborare i dati. Jon Olsen, CEO di Firefly, ha sottolineato il valore della loro piattaforma AI per gli studi clinici, mentre Ian McDonald, CEO di Bright Minds, ha affermato che i risultati convalidano il loro approccio e indicano che BMB-101 sta raggiungendo la penetrazione cerebrale come previsto.
Con il completamento di questo studio di Fase 1, BMB-101 è ora considerato un asset pronto per la Fase 2, e Bright Minds prevede di procedere con una richiesta di nuovo farmaco investigativo.
Firefly Neuroscience (NASDAQ: AIFF) ha anunciado una colaboración con Bright Minds Biosciences para analizar los datos del positivo estudio de Fase 1 de Bright Minds, utilizando la tecnología BNA™ impulsada por IA de Firefly. El estudio se centró en el compuesto principal de Bright Minds, BMB-101, y utilizó auriculares EEG proporcionados por el socio de Firefly, Zeto.
El análisis de datos qEEG mostró resultados positivos, con grabaciones EEG realizadas en múltiples puntos durante el estudio. Se utilizó la avanzada plataforma de análisis EEG de Firefly para procesar los datos. Jon Olsen, CEO de Firefly, destacó el valor de su plataforma de IA para los estudios clínicos, mientras que Ian McDonald, CEO de Bright Minds, afirmó que los resultados validan su enfoque e indican que BMB-101 está logrando una penetración cerebral como se había previsto.
Con la finalización de este estudio de Fase 1, BMB-101 ahora se considera un activo listo para la Fase 2, y Bright Minds planea avanzar con una presentación de nuevo medicamento en investigación.
파이어플라이 뉴로사이언스(NASDAQ: AIFF)는 브라이트 마인즈 바이오사이언스와 협력하여 파이어플라이의 AI 기반 BNA™ 기술을 사용하여 브라이트 마인즈의 긍정적인 1상 연구 데이터를 분석한다고 발표했습니다. 이 연구는 브라이트 마인즈의 주요 화합물인 BMB-101에 중점을 두었으며, 파이어플라이의 파트너인 제토(Zeto)가 제공한 EEG 헤드셋을 사용했습니다.
qEEG 데이터 분석은 연구 기간 중 여러 시점에서 수집된 EEG 기록에서 긍정적인 결과를 보여주었습니다. 파이어플라이의 고급 EEG 분석 플랫폼이 데이터를 처리하는 데 사용되었습니다. 파이어플라이의 CEO인 존 올슨(Jon Olsen)은 임상 연구를 위한 자사의 AI 플랫폼의 가치를 강조했으며, 브라이트 마인즈의 CEO인 이안 맥도날드(Ian McDonald)는 이 결과가 그들의 접근 방식을 validation하며 BMB-101이 예측한 대로 뇌에 침투하고 있다고 밝혔습니다.
이 1상 연구가 완료됨에 따라 BMB-101은 이제 2상 준비 자산으로 간주되며, 브라이트 마인즈는 신약 연구 제출을 진행할 계획입니다.
Firefly Neuroscience (NASDAQ: AIFF) a annoncé une collaboration avec Bright Minds Biosciences pour analyser les données de l'étude de Phase 1 positive de Bright Minds, en utilisant la technologie BNA™ pilotée par l'IA de Firefly. L'étude s'est concentrée sur le composé principal de Bright Minds, BMB-101, et a utilisé des casques EEG fournis par le partenaire de Firefly, Zeto.
L'analyse des données qEEG a montré des résultats positifs, avec des enregistrements EEG effectués à plusieurs moments durant l'étude. La plateforme avancée d'analyse EEG de Firefly a été utilisée pour traiter les données. Jon Olsen, PDG de Firefly, a souligné la valeur de leur plateforme d'IA pour les études cliniques, tandis qu'Ian McDonald, PDG de Bright Minds, a déclaré que les résultats valident leur approche et indiquent que BMB-101 atteint la pénétration cérébrale comme prévu.
Avec l'achèvement de cette étude de Phase 1, BMB-101 est désormais considéré comme un actif prêt pour la Phase 2, et Bright Minds prévoit de poursuivre une soumission de nouveau médicament expérimental.
Firefly Neuroscience (NASDAQ: AIFF) hat eine Zusammenarbeit mit Bright Minds Biosciences angekündigt, um Daten aus der positiven Phase-1-Studie von Bright Minds zu analysieren, wobei die KI-gestützte BNA™-Technologie von Firefly verwendet wird. Die Studie konzentrierte sich auf die Hauptverbindung von Bright Minds, BMB-101, und nutzte EEG-Headsets, die von Fireflys Partner Zeto bereitgestellt wurden.
Die Analyse der qEEG-Daten zeigte positive Ergebnisse, wobei EEG-Aufzeichnungen zu mehreren Zeitpunkten während der Studie durchgeführt wurden. Die fortschrittliche EEG-Analyseplattform von Firefly wurde zur Datenverarbeitung verwendet. Jon Olsen, CEO von Firefly, hob den Wert ihrer KI-Plattform für klinische Studien hervor, während Ian McDonald, CEO von Bright Minds, erklärte, dass die Ergebnisse ihren Ansatz validieren und darauf hinweisen, dass BMB-101 die voraussagte Gehirndurchdringung erreicht.
Mit dem Abschluss dieser Phase-1-Studie wird BMB-101 nun als Phase-2-bereites Asset betrachtet, und Bright Minds plant, mit einer investigativen Neuentwicklungsanmeldung voranzuschreiten.
- Successful collaboration with Bright Minds Biosciences on Phase 1 study analysis
- Positive qEEG data results for BMB-101 compound
- BMB-101 achieved brain penetration and activated target receptors as predicted
- BMB-101 advanced to Phase 2 ready status
- None.
Insights
The collaboration between Firefly Neuroscience and Bright Minds Biosciences marks a significant step in leveraging AI for neurological drug development. Firefly's FDA-cleared BNA™ technology, combined with Zeto's EEG headsets, provides a powerful platform for analyzing brain activity data from clinical trials.
Key points:
- Firefly's AI-driven analysis of Bright Minds' Phase 1 study data for BMB-101 yielded positive qEEG results.
- The study design, using 19-electrode EEG headsets and multiple recording timepoints, allows for comprehensive brain activity assessment.
- BMB-101 shows promising brain penetration and target receptor activation, important for potential efficacy in neuropsychiatric disorders and refractory epilepsy.
- The successful completion of this Phase 1 study positions BMB-101 as a Phase 2-ready asset, accelerating its development timeline.
This collaboration demonstrates the growing importance of AI in drug development, potentially reducing time and costs while improving the quality of data analysis. For investors, this partnership could signify increased value in both companies' pipelines and technological capabilities.
During the Phase 1 study, subjects utilized EEG headsets provided by Firefly partner, Zeto, after which the data was analyzed using Firefly’s advanced AI BNA technology analysis platform
TORONTO, Oct. 16, 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 collaborating with Bright Minds Biosciences Inc. (CSE:DRUG) (NASDAQ:DRUG) (“Bright Minds” or the “Company”), a biotechnology company focused on developing novel drugs for the targeted treatment of neuropsychiatric disorders and refractory epilepsy, to analyze the data from its first-in-human Phase 1 study of its lead compound, BMB-101.
The study demonstrated positive results of the qEEG (Quantitative Electroencephalogram) data. During the EEG recording, subjects were seated with a U.S. Food and Drug Administration (FDA)- approved 19 electrode EEG headset provided by Firefly strategic partner, Zeto™ Inc. Channels were sampled at 250 or 500 Hz and referenced to A1/A2 channels (linked-ears reference) during recording. The EEG recording time was 10 minutes (~5 minutes resting with eyes closed and ~5 minutes resting with eyes open). There were four EEG recording timepoints: day 1 pre-dose (immediately before dosing) and post-dose (1h after dosing), and day 7 pre-dose and post-dose. Data was analyzed using the FireFly Neuroscience advanced EEG analysis platform.
“Our artificial intelligence platform has tremendous value for the advancement and insight of clinical studies,” said Jon Olsen, CEO of Firefly. “We are pleased to have successfully collaborated with Bright Minds to analyze the data of their phase 1 study and look forward to working closely with their team once again as well as other leading biotechnology companies.”
“The positive topline findings from our recently completed Phase 1 study of BMB-101, together with the observations from the qEEG portion of the study, validate our approach, as we continue to evaluate this important product candidate. BMB-101 is clearly [getting into the brain/achieving brain penetration] and activating the target receptors as we had predicted, setting us up for potential success in a number of indications that have been validated with the 5-HT2C mechanism. With this study complete, BMB-101 is now a Phase 2 ready asset, and we intend to move forward with an investigative new drug submission immediately,” stated Ian McDonald, CEO of Bright Minds.
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 BMB-101
BMB-101, a highly selective 5-HT2C, Gq-protein biased agonist, has demonstrated compelling activity in a host of in vitro and in vivo nonclinical tests. Compared to Lorcaserin, BMB-101 exhibits strong Gq biased signaling, coupled with minimal beta-arrestin recruitment. Bright Minds believes that G-protein biased signaling translates to better tolerance profile for this second-generation 5-HT2C agonist, making BMB-101 a best-in-class 5-HT2C agonist. Mechanistically, Serotonin (5-Hydroxytryptamine, 5-HT) is a monoamine neurotransmitter widely expressed in the central nervous system, and drugs modulating 5-HT have made a major impact in mental health disorders. Central 5-HT systems have long been associated with the control of ingestive behaviors and the modulation of the behavioral effects of psychostimulants, opioids, alcohol, and nicotine. Results of clinical trials and animal studies indicate that 5-HT2C receptor agonists may have therapeutic potential in the treatment of addiction by decreasing the intake of opioids as well as impulsive behavior that can escalate compulsive drug use. BMB-101 is a new chemical entity (NCE) and constitutes a novel scaffold 5-HT2C agonist.
5-HT2C agonism is a well proven anticonvulsant mechanism. In translational animal models, BMB-101 demonstrated a significant reduction in both the number and intensity of epileptic seizures and is a promising candidate for the treatment of Dravet Syndrome and other epilepsies. The Phase 1 trial (NCT 05397041) has been completed and BMB-101 is now Phase 2 ready.
About Bright Minds
Bright Minds is focused on developing novel transformative treatments for neuropsychiatric disorders, epilepsy, and pain. Bright Minds has a portfolio of next-generation serotonin agonists designed to target neurocircuit abnormalities that are responsible for difficult to treat disorders such as treatment resistant epilepsy, treatment resistant depression, PTSD, and pain. The Company leverages its world-class scientific and drug development expertise to bring forward the next generation of safe and efficacious drugs. Bright Minds’ drugs have been designed to potentially retain the powerful therapeutic aspects of psychedelic and other serotonergic compounds, while minimizing the side effects, thereby creating superior drugs to first-generation compounds, such as fenfluramine, psilocybin, LSD, and ibogaine.
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.
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
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