Beacon Biosignals

We're excited to announce that Takeda and Beacon Biosignals have entered a strategic collaboration to conduct at-home sleep monitoring to support clinical trials in the Takeda orexin franchise and neuroscience portfolio! Takeda will leverage Beacon's neurophysiology platform, including the FDA-cleared Dreem 3S EEG headband, AI-powered analytics, and clinico-EEG database.   Quantitative sleep data has been historically difficult to collect and analyze at the speed and scale necessary to support clinical development. This collaboration enables Takeda to collect lab-quality sleep data from a patient's home, longitudinally and at-scale, to characterize sleep dysfunction and enable more personalized treatment options. “Takeda is committed to developing life-transforming therapies for areas of highest unmet need, including narcolepsy and other sleep-wake disorders. In partnering with Beacon, we will now have access to real-time, longitudinal sleep data that better reflects the daily burden of living with these disorders,” said Elena Koundourakis, head of the Orexin Franchise Development and Neuroscience Portfolio Strategy at Takeda. “The Beacon Platform will be used to inform our clinical trial designs including defining quantitative, digital endpoints based on objective measures of sleep patterns, which could support more tailored treatment approaches and improve the diagnostic journey for patients.”   We're committed to improving the patient experience and operationalizing at-home sleep endpoints at-scale, and we're thrilled to work with Takeda to pave the way towards novel therapeutic approaches for neurological and psychiatric indications. Full press release: https://lnkd.in/gERHr48j To learn more about Beacon: https://lnkd.in/errYwFaE #takeda #beacon #collaboration #EEG #Dreem #narcolepsy #orexin

Join us at HLTH USA where Beacon’s CBO David Matthews, PhD will be on stage with our Takeda partners discussing Digital Innovation in Sleep! #sleep #digitalhealth #HLTH

Alongside Project Sleep, in recognition of #WorldNarcolepsyDay, we stand strong with patients and communities impacted by #narcolepsy and related sleep-wake conditions. Our vision is to continue enhancing the lives of patients, paving the way for better health and a brighter future. Meet Kelsey, a person living with narcolepsy type 1 (NT1) who describes her own experience and journey with this rare, often misunderstood disorder. Watch the full video: https://lnkd.in/efdPH3rS Kelsey is a paid speaker for Takeda. Individual symptoms and experiences may vary. Please consult a healthcare provider with questions about any health concerns you may be experiencing. Takeda does not currently have any approved treatments for narcolepsy.

Congratulations to Beacon partner Longboard Pharmaceuticals on their success in receiving the FDA's Rare Pediatric Disease designation and Orphan Drug designation for its investigational drug bexicaserin for the treatment of Dravet syndrome. We're proud to work with bold innovators serving rare disease populations with significant unmet medical needs, and especially excited for the potential impact that bexicaserin will have for Dravet Syndrome patients! Congrats Randall Kaye and the entire Longboard team!

📣 Beacon is proud to announce the launch of the HEADFIRST basket study (“Home EEG Application and Dreem Feasibility In Research Study”), with our first cohorts enrolled via partnership with the Lennox-Gastaut Syndrome (LGS) Foundation! HEADFIRST is a basket study that aims to assess the Dreem 3S headband's usability in tracking sleep and brain activity in both pediatric patients with neurodevelopmental disorders and in neurotypical controls, enrolling up to 300 participants across multiple disorders. The first phase of the study, in partnership with the Lennox-Gastaut Syndrome (LGS) Foundation, focuses on usability, reliability, and clinical utility of using Dreem for a pediatric cohort with LGS. Sleep disturbances are a known complication in pediatric neurodevelopmental disorders, significantly affecting patients and their caregivers. In this study, Beacon will assess the extent to which the Dreem3S overcomes the challenges posed by traditional wired EEG systems, which can be intrusive and disruptive while limiting longitudinal data collection. Additionally, the study will harness Beacon’s machine learning analytics platform to measure quantitative sleep and EEG endpoints, potentially paving the way for novel therapeutic approaches and improved patient outcome measures. The LGS Foundation will raise awareness for the study’s first cohorts, ensuring that families affected by LGS have the opportunity to participate. Furthermore, we're excited to collaborate with two biopharma partners who have joined the study at launch to share data, gain insights, and explore candidate sleep EEG biomarkers. With HEADFIRST, we're uniting to make a meaningful difference in the quality of life of patients and families impacted by LGS and other neurodevelopmental disorders. We encourage other biopharma leaders to reach out to learn more about adding specific cohorts to HEADFIRST and exploring the importance of sleep physiology for their development programs. The Dreem 3S is an FDA 510(k)-cleared medical device cleared to study sleep in adults, and is being evaluated for research purposes in pediatric populations. To learn more about how you can utilize Dreem in your trials, reach out to us: https://beacon.bio/contact See today's press release here: https://shorturl.at/DwCY0 #HEADFIRST #Dreem #EEG #LennoxGastaut #ClinicalTrials #Sleep #biomarkers

Come say hello at ISCTM 2024 [https://lnkd.in/eGUR9fH] in San Diego, CA this Thursday September 12, where our Chief Business Officer David Matthews, PhD will be presenting on our computational approaches to leverage EEG and PSG for endpoints in developmental disorders! In this presentation, we share recent computational approaches used to discover biomarkers in neurodevelopmental and sleep disorders from EEG and PSG data, including seizure burden, periodic discharges, interictal epileptiform discharges, and others, across a diverse set of developmental and epileptic encephalopathies (DEEs). Beacon is actively working with biopharma partners to leverage our FDA 510(k)-cleared algorithms for EEG endpoints in clinical trials for epilepsy, sleep disorders, psychiatric and neurodegenerative disorders, and more. To meet with us at the ISCTM conference or to learn more: beacon.bio/contact #ISCTM2024 #Dreem #Conference #SanDiego

Beacon extends its congratulations to Gain Therapeutics, for its positive Phase 1 data last week of GT-02287 in healthy volunteers! The mechanism of GT-02287 aims to restore the function of a lysosomal protein enzyme called glucocerebrosidase, which selectively affects disorders that have mutations in the GBA1 gene, the most common genetic abnormality associated with Parkinson’s. The Phase 1 trial demonstrated that the drug was “safe and generally well tolerated up to and including the highest planned dose levels across all age groups.” The allosteric modulator drug class has struggled to yield efficacious drugs for PD in recent history, and this latest Phase 1 result shows promise for Gain Therapeutics and for PD patients with and without the GBA1 mutation. At Beacon, we're working with our biopharma partners to measure treatment-responsive sleep biomarkers in neurodegenerative disorders including Parkinson's disease, aiming to identify predictive biomarkers and improve patient outcomes. Read more: https://lnkd.in/gwa2bxhU To learn more about how we can work together to make an impact in Parkinson's disease, contact us below: https://beacon.bio/contact #parkinsons #PD #GBA1 #sleep #EEG #clinicaltrials

Neuroscientists and data scientists, Beacon Biosignals keeps growing and we’re hiring! Come join the Data Science Group at Beacon to tackle some of the hardest challenges in brain science and impact billions of patients along the way. 🧠🧠🧠

We're delighted to share that Beacon Biosignals held a well-attended virtual site visit with FDA's The Center for Devices and Radiological Health’s (CDRH) Experiential Learning Program (ELP) on August 7, 2024. The ELP is a novel learning opportunity for the FDA (CDRH and others, as relevant) to facilitate knowledge exchange, close knowledge gaps between emerging and innovative technology, and advance medical device research and development. Our virtual site visit focused on “Connected Care Digital Health Technologies in a Home Setting: Home Use Digital Health Technologies”. The home environment is an integral part of the fast-evolving healthcare system around the world. It enables broad access to novel medical products for every individual, irrespective of any limitations. The importance of the future of the home environment in medical product development was also highlighted in the recent public meeting hosted by the FDA (“Home as a Heath Care Hub – Stakeholder  Listening Session” - https://lnkd.in/eQhC_m_w). The August 7 virtual visit featured sessions on the 510k-cleared Dreem headband, our advanced ML-based analytical algorithms, device and analytical algorithm research and development, and importantly, voice of the patients and caregivers, and physicians. Patient focused drug development (PFDD) is an important component of Beacon Biosignals’ vision and mission, and ensuring their voice is heard throughout our research and development life cycle enables us to continue innovation and development of our novel device and algorithms to maximize impact, utility, relevance and reliability in a real-world environment. Learn more about the ELP: https://lnkd.in/eFEa2yYM #fda #clinicaltrials #sleep

We thank BioPharma-Reporter for their coverage of our collaboration with Skye Bioscience Inc.! Together, we're leveraging our FDA 510(k)-cleared Dreem sleep EEG headband to characterize changes in sleep quality in obesity and sleep apnea. This latest article covers an in-depth Q&A about Skye's upcoming CBEYOND™ Phase 2 trial of Nimacimab, a CB1 inhibitor. Beacon will be deploying Dreem in a sub-study of CBEYOND, measuring multiple nights of sleep across the trial where enrolled participants are taking Nimacimab alone or in combination with semaglutide. The insights gathered from characterizing changes in objective sleep quality across the treatment period may enable Skye to better target patient subgroups and optimize treatments for obesity, OSA and beyond. Read the full article below: https://lnkd.in/g9Ns77Aa Reach out to learn more about working together for your clinical trials: https://beacon.bio/contact #skye #beacon #collaboration #CB1 #EEG #Dreem #OSA #obesity #GLP1