Arrivo BioVentures Announces Positive Results from qEEG and BNA™ Study of SP-624 on Neural Brain Activity Related to Depression and Cognition
Arrivo BioVentures reported positive results from its SP-624-103 study evaluating SP-624's impact on neurological pathways. The double-blind, placebo-controlled study's first cohort, comprising 12 healthy subjects, showed significant brain activity changes after a single 20mg dose. Key findings include increased beta power in frontal-central regions and decreased delta power, suggesting enhanced neural synchronization and cortical activation.
The study utilized Firefly Neuroscience's (NASDAQ: AIFF) brain network analytics (BNA™) and qEEG assessments. SP-624, a SIRT6 activator, demonstrated potential for treating females with Major Depression. The company is currently conducting a Phase 2b/3 study for major depressive disorder, with Cohort 2 actively enrolling 12 MDD patients.
Arrivo BioVentures ha riportato risultati positivi dal suo studio SP-624-103 che valuta l'impatto di SP-624 sui percorsi neurologici. Il primo gruppo dello studio, in doppio cieco e controllato con placebo, composto da 12 soggetti sani, ha mostrato cambiamenti significativi nell'attività cerebrale dopo una singola dose di 20mg. I risultati chiave includono un aumento della potenza beta nelle regioni fronto-centra e una diminuzione della potenza delta, suggerendo una sincronizzazione neurale migliorata e un'attivazione corticale.
Lo studio ha utilizzato le analisi della rete cerebrale (BNA™) e le valutazioni qEEG di Firefly Neuroscience (NASDAQ: AIFF). SP-624, un attivatore di SIRT6, ha dimostrato un potenziale trattamento per le donne con depressione maggiore. Attualmente, l'azienda sta conducendo uno studio di fase 2b/3 per il disturbo depressivo maggiore, con il secondo gruppo che sta attivamente arruolando 12 pazienti con MDD.
Arrivo BioVentures reportó resultados positivos de su estudio SP-624-103 que evalúa el impacto de SP-624 en las vías neurológicas. El primer cohorte del estudio, en doble ciego y controlado con placebo, compuesto por 12 sujetos sanos, mostró cambios significativos en la actividad cerebral después de una sola dosis de 20mg. Los hallazgos clave incluyen un aumento en la potencia beta en las regiones fronto-centras y una disminución en la potencia delta, sugiriendo una sincronización neural mejorada y una activación cortical.
El estudio utilizó las analíticas de red cerebral (BNA™) y las evaluaciones qEEG de Firefly Neuroscience (NASDAQ: AIFF). SP-624, un activador de SIRT6, ha demostrado potencial para tratar a mujeres con depresión mayor. La empresa está realizando actualmente un estudio de fase 2b/3 para el trastorno depresivo mayor, con el Cohorte 2 reclutando activamente a 12 pacientes con MDD.
Arrivo BioVentures는 SP-624의 신경 경로에 미치는 영향을 평가하는 SP-624-103 연구의 긍정적인 결과를 보고했습니다. 이중 맹검, 위약 대조 연구의 첫 번째 집단은 12명의 건강한 참여자로 구성되어 있으며, 20mg 단일 투여 후 중요한 뇌 활동 변화가 나타났습니다. 주요 발견으로는 전두-중심 영역에서의 베타 파워 증가와 델타 파워 감소가 있으며, 이는 뇌 신경 동기화 및 피질 활성화 증가를 시사합니다.
이 연구는 Firefly Neuroscience (NASDAQ: AIFF)의 뇌 네트워크 분석 (BNA™) 및 qEEG 평가를 활용했습니다. SP-624는 SIRT6 활성제로, 주요 우울증을 앓고 있는 여성 치료 가능성을 보여주었습니다. 회사는 현재 주요 우울 장애에 대한 2b/3상 연구를 진행 중이며, 제2 집단에서 12명의 MDD 환자를 적극적으로 모집하고 있습니다.
Arrivo BioVentures a rapporté des résultats positifs de son étude SP-624-103 évaluant l'impact de SP-624 sur les voies neurologiques. La première cohorte de l'étude, en double aveugle et contrôlée par placebo, comprenant 12 sujets sains, a montré des changements significatifs dans l'activité cérébrale après une seule dose de 20mg. Les principales conclusions incluent une augmentation de la puissance bêta dans les régions fronto-centrales et une diminution de la puissance delta, suggérant une synchronisation neuronale améliorée et une activation corticale.
L'étude a utilisé les analyses de réseau cérébral (BNA™) et les évaluations qEEG de Firefly Neuroscience (NASDAQ: AIFF). SP-624, un activateur de SIRT6, a montré un potentiel pour traiter les femmes souffrant de dépression majeure. L'entreprise mène actuellement une étude de phase 2b/3 pour le trouble dépressif majeur, avec la Cohorte 2 qui recrute activement 12 patients atteints de MDD.
Arrivo BioVentures hat positive Ergebnisse aus seiner SP-624-103-Studie berichtet, die die Auswirkungen von SP-624 auf neurologische Bahnen bewertet. Die erste Kohorte der doppelblind und placebo-kontrollierten Studie, bestehend aus 12 gesunden Versuchsteilnehmern, zeigte nach einer einzelnen 20mg-Dosis signifikante Veränderungen der Gehirnaktivität. Zu den wichtigsten Erkenntnissen gehören ein Anstieg der Beta-Leistung in fronto-zentralen Regionen und ein Rückgang der Delta-Leistung, was auf eine verbesserte neuronale Synchronisation und kortikale Aktivierung hindeutet.
Die Studie nutzte die Gehirnnetzwerkanalysen (BNA™) und qEEG-Bewertungen von Firefly Neuroscience (NASDAQ: AIFF). SP-624, ein SIRT6-Aktivator, zeigte Potenzial zur Behandlung von Frauen mit schwerer Depression. Das Unternehmen führt derzeit eine Phase-2b/3-Studie zum major depressive disorder durch, wobei Kohorte 2 aktiv 12 MDD-Patienten rekrutiert.
- Positive brain activity changes observed after single 20mg dose
- Enhanced neural synchronization and cortical activation demonstrated
- Improved cognitive processing and attention indicators
- Phase 2b/3 study for major depressive disorder currently enrolling
- Study results to healthy subjects in Cohort 1
- Efficacy in MDD patients not yet demonstrated
Insights
The qEEG and BNA study results for SP-624 represent a significant milestone in neuropsychiatric drug development. The observed increase in beta power and decrease in delta power in frontal-central regions after a single 20mg dose suggests robust central nervous system engagement. These neurophysiological changes - particularly the enhanced synaptic plasticity and reduced cortical arousal - align with therapeutic mechanisms needed for treating depression.
The ongoing Phase 2b/3 study positions SP-624 as a potential first-in-class SIRT6 activator specifically targeting female depression patients. The market opportunity is substantial, as women are twice as likely to experience major depressive disorder compared to men. If successful, this gender-specific approach could address an underserved demographic representing over
For Firefly Neuroscience (AIFF), this validation of their BNA™ technology as a biomarker platform in CNS drug development could lead to increased adoption across the pharmaceutical industry. This could translate to expanded licensing revenues and strategic partnership opportunities.
The neurological data presents compelling evidence of SP-624's mechanism of action. The observed modulation of beta and delta frequencies indicates the drug is effectively crossing the blood-brain barrier and engaging relevant neural circuits. The enhanced evoked potential responses suggest improvements in both bottom-up sensory processing and top-down cognitive control - key domains affected in depression.
Think of beta waves as the brain's "busy signal" - they indicate active thinking and focus. The increase in beta activity, particularly in frontal regions responsible for executive function, suggests SP-624 may help "wake up" areas of the brain that become sluggish during depression. Meanwhile, the reduction in delta waves - typically associated with sleep and low arousal - indicates the drug is helping shift the brain from a "powered down" depressive state to a more alert, engaged state.
Findings show significant brain activity after a single 20mg dose of SP-624 in healthy subjects
Phase 2b/3 study of SP-624 in major depressive disorder is underway
SP-624 has the potential to be the first treatment specifically for females with Major Depression
Arrivo’s SP-624-103 study is a double blind, placebo-controlled study with three cohorts. Cohort 1 is comprised of 12 healthy subjects (8 active, 4 placebo) who received 20mg of SP-624 over a 15-day dosing period. Assessments, including quantitative EEG (qEEG) and Firefly Neuroscience’s (NASDAQ: AIFF) brain network analytics (BNA™), were performed at Day One and Day 15 pre- and post-dose. Cohort 2 is actively enrolling 12 patients diagnosed with major depressive disorder (MDD). The subject composition of the 3rd cohort will be determined after the completion of the second cohort.
Cohort 1 results of the SP-624-103 study include:
- Subjects showed an increase in beta power, particularly in the frontal-central regions compared to patients taking placebo after a single dose, suggesting enhanced synaptic plasticity and neuronal connectivity.
- Subjects showed a decrease in delta power. This is important as increases in delta activity are often associated with reduced cortical arousal and depressive states.
- Evoked potential response findings suggest enhanced neural efficiency in early perceptual processing and improved decision-making speed and context updating.
“An increase in beta power and decrease in delta power are indicative of enhanced neural synchronization, excitability and cortical activation,” said Arrivo BioVentures Chief Medical Officer Dr. Joel Raskin. “These findings could be indicative of SP-624’s ability to alleviate depressive symptoms by normalizing cortical activity, potentially improving cognitive processing, attention and cortical arousal, with implications for numerous neuropsychiatric diseases.”
“We are continuing to explore the possibilities with SP-624 and the SIRT6 mechanism of action in this trial along with a Phase 2b/3 study for major depressive disorder that we are currently enrolling,” said Arrivo Chief Executive Officer, Steve Butts. “The SP-624-103 study provides solid evidence that we have an active drug in the central nervous system and increases our confidence in the potential of SP-624 in MDD and other cognitive disorders.”
About Arrivo BioVentures
Arrivo is developing first-of-its-kind medicines that target the root cause of hard-to-treat diseases with the goal of achieving meaningful outcomes for patients, allowing them to live longer, healthier lives. Arrivo has two clinical-stage pipeline candidates, SP-624 for major depressive disorder and RABI-767 for predicted severe acute pancreatitis. Arrivo is based in
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.
*BNA™ is a trademark of Firefly Neuroscience, Inc.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250110201020/en/
Media Contact for Arrivo Bio
Alexis Feinberg
Vice President, ICR Healthcare
Alexis.feinberg@westwicke.com
Source: Arrivo BioVentures
FAQ
What were the key findings of Arrivo's SP-624-103 study using AIFF's BNA technology?
How many subjects were included in the SP-624-103 study's first cohort?
What is the current status of SP-624's Phase 2b/3 trial for major depressive disorder?
How does SP-624 potentially differ from other depression treatments?
