Latest news with #TRD
Business Wire
a day ago
- Business
- Business Wire
LivaNova Initiates Process with U.S. Centers for Medicare and Medicaid Services for Reconsideration of National Coverage for VNS Therapy for Treatment-Resistant Depression
LONDON--(BUSINESS WIRE)--LivaNova PLC (Nasdaq: LIVN), a market-leading medical technology company, today announced it has initiated the process with the U.S. Centers for Medicare and Medicaid Services (CMS) to seek reconsideration of national Medicare coverage for VNS Therapy™ in unipolar patients with treatment-resistant depression (TRD). The first step in the process for making a National Coverage Determination (NCD) is the submission of a draft formal request for CMS reconsideration. "We have reached an important point in our pursuit to obtain national coverage for VNS Therapy for unipolar patients with depression that is difficult to treat,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. Five critical articles featuring outcomes from in-depth data analyses on primary and select secondary endpoints in the RECOVER study have recently been published in or accepted by peer-reviewed journals, and the totality of data presented in these articles serves as the basis of the Company's request to CMS. The company believes these articles satisfy the Coverage with Evidence Development (CED) requirement of sharing peer-reviewed, publicly accessible results of pre-specified outcomes measured in the RECOVER study. In addition to the five articles, the request for coverage reconsideration includes strong 24-month clinical outcomes from the unipolar cohort of the RECOVER clinical study that demonstrate the substantial retention of benefits and the durability of VNS Therapy over time. 'We have reached an important point in our pursuit to obtain national coverage for VNS Therapy for unipolar patients with depression that is difficult to treat,' said Ahmet Tezel, Ph.D., Chief Innovation Officer of LivaNova. 'Our follow-on analyses of the RECOVER unipolar data demonstrate that symptoms alone may not be the sole source upon which to gauge the clinical impact of treatment. Instead, symptoms, function, and quality of life taken together present a more complete picture of treatment effectiveness. We are eager to review this powerful data with CMS during the reconsideration process.' Final Articles in Critical Series Analyze RECOVER Primary and Select Secondary Endpoint Data Two new in-depth analyses 1,2 on primary and select secondary endpoints in the RECOVER trial have recently been published and a third accepted by peer-reviewed journals. Prior to these articles, two initial articles were published in Brain Stimulation 3,4 in December 2024, completing the series of five critical articles in total. Collectively, the articles highlight the significant unmet need of this markedly ill population with TRD. The RECOVER data demonstrates that VNS Therapy improves symptoms, function, and quality of life in TRD patients over time. These are outcome measures identified as clinically relevant by CMS. Depressive symptoms, daily function, and quality of life taken together, as a novel composite metric, present a more complete picture of treatment effectiveness than symptoms alone. The fifth and final critical publication utilizes this composite metric and demonstrates favorable response to VNS Therapy in TRD patients who had previously failed multiple treatments, including interventional therapies. Researchers found that patients with previous ECT or TMS treatment had statistically significant and clinically meaningful benefits with active VNS Therapy. Notably, VNS Therapy is the only treatment that has demonstrated therapeutic effects in patients who previously failed ECT. 24-Month VNS Therapy Data Show Durability, Increasing Response Across All Outcome Measures New top-line 24-month data from the RECOVER study show that, across all outcome measures, VNS Therapy patients in the active arm of RECOVER experienced a substantial durability of benefit from month 12 to month 24. Of those patients who at 12 months had achieved clinically meaningful benefit, the median durability of benefit was 81.3% across all outcome measures at the 24-month assessment. This is considerable durability for these unipolar patients who, at baseline in the RECOVER study, had failed more than 13 antidepressant treatments on average. Observing all VNS Therapy patients in the active treatment arm of the RECOVER trial from month 12 to month 24, researchers also found improvement in all outcome measures, with the median rate of response, or clinically meaningful benefit, increasing from 40.2% at month 12 to 51.6% at month 24. 'There is no clinical evidence to demonstrate that there are any other therapies, including pharmacotherapies and interventional therapies such as electroconvulsive therapy (ECT) and transcranial magnetic stimulation (TMS), that can claim this profound level of sustained durability and increasing benefit,' said A. John Rush, M.D., Professor Emeritus at Duke-National University of Singapore Medical School who has spent 25 years researching VNS Therapy for TRD and served as Chief Consultant on the RECOVER trial. 'These are critical findings that offer hope to treatment-resistant depression patients and their loved ones, who have struggled for years to find effective options. Patients not only stay better – they also continue to get better.' Improvement in suicidality shows statistically significant separation as early as month three LivaNova conducted additional in-depth analyses specifically evaluating suicidality for the active treatment arm of RECOVER through the first 12 months of therapy. Using a composite suicidality measure 5, results showed an estimated 43% higher odds of achieving meaningful improvement in suicidal ideation symptoms versus the control arm. Of specific interest, there was separation between the active and control arms on the composite suicidality metric as early as month three. Additionally, the observed separation was consistent throughout the initial 12 months. 'The composite suicidality outcome is especially encouraging because we can see a separation between the active and control arms so early in the study,' said Charles Conway, M.D., director of the Washington University Resistant Mood Disorders Center at Washington University School of Medicine in St. Louis. Conway is the RECOVER study's lead investigator. 'We're eager to further evaluate the suicidality data beyond 12 months and, in the context of the overall durability story of VNS Therapy, determine whether this benefit also continues to improve over time.' While not included in the initial submission to CMS, the suicidality data will be provided in detail to the agency upon publication in a peer-reviewed journal. RECOVER launched in 2019 as part of a CED framework per the CMS NCD process. For the unipolar cohort of RECOVER, enrollment was completed in March 2023, and the 12-month follow-up for those patients was completed in March 2024. No new safety issues were identified in the study. About RECOVER LivaNova's VNS Therapy™ System has been approved for the treatment of depression since earning CE Mark in 2001 and premarket approval (PMA) from the U.S. Food and Drug Administration in 2005. RECOVER stands for A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression. The largest randomized clinical study of its kind, RECOVER is examining up to 1,000 patients ages 18 or older who have unipolar or bipolar depression that is difficult to treat. A total of 493 adults with at least four documented unsuccessful attempts with antidepressant treatments participated in the unipolar cohort of the RECOVER study. The double-blind, randomized controlled study is assessing how VNS Therapy can offer patients relief from their depressive symptoms and improve quality of life. It is being carried out at up to 100 leading hospitals and medical centers across the United States. About VNS Therapy for Depression The VNS Therapy™ System, Symmetry™, is U.S. Food and Drug Administration-approved and indicated in the U.S. for the adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments. The most commonly reported side effects are voice alteration or hoarseness, prickling or tingling in the skin, increased coughing, shortness of breath, and sore throat. Infection is the most common complication of the surgical procedure. Important safety information is available at References Conway CR, et al. An examination of symptoms, function, and quality of life as conjoint clinical outcome domains for treatment-resistant depression. Journal of Mood & Anxiety Disorders. April 14, 2025. DOI: 10.1016/ Sackeim HA, et al. Characterizing the effects of vagus nerve stimulation on symptom improvement in markedly treatment-resistant major depressive disorder: A RECOVER trial report. July 1, 2025. DOI: 10.1016/ Conway CR, et al. Vagus nerve stimulation in treatment-resistant depression: A one-year, randomized, sham-controlled trial. Brain Stimulation. Dec. 18, 2024. DOI: 10.1016/ Rush AJ, et al. Effects of vagus nerve stimulation on daily function and quality of life in markedly treatment-resistant major depression: Findings from a one-year, randomized, sham-controlled trial. Brain Stimulation. Dec. 18, 2024. DOI: 10.1016/ The composite suicidality metric was created by adding a suicidality-specific question from each of MADRS, Quick Inventory of Depressive Symptomology–Self Report, or QIDS-SR, and Quick Inventory of Depressive Symptomology–Clinical, or QIDS-C. About LivaNova LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to provide hope for patients and their families through medical technologies, delivering life-changing solutions in select neurological and cardiac conditions. Headquartered in London, LivaNova employs approximately 2,900 employees and has a presence in more than 100 countries for the benefit of patients, healthcare professionals, and healthcare systems worldwide. For more information, please visit Safe Harbor Statement This news release contains 'forward-looking statements' concerning the Company's goals, beliefs, expectations, strategies, objectives, plans, underlying assumptions, and other statements that are not necessarily based on historical facts. These statements include, but are not limited to, statements regarding the RECOVER study, the VNS Therapy™ System, Symmetry™, and the likelihood that the Company is successful in obtaining national Medicare coverage for its VNS Therapy™ System. Actual events may differ materially from those indicated in our forward-looking statements as a result of various factors, including those factors set forth in Item 1A of the Company's most recent Annual Report on Form 10-K, as supplemented by any risk factors contained in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. LivaNova undertakes no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.
New Indian Express
2 days ago
- Business
- New Indian Express
Vijayawada division TDR department gets ISO certification
VIJAYAWADA: The Vijayawada Division's Traction Distribution (TRD) Department has been awarded the International Organisation for Standardisation (ISO) 9001:2015 Quality Management System Certification, making it the first division across the national network to achieve this recognition for its entire TRD unit. The certification, issued by QRO Certifications through Harsha Technologies, Hyderabad, follows a comprehensive audit process assessing service consistency and quality. It covers 22 key TRD locations, including depots, offices, and the central store, acknowledging the department's high standards in maintaining Overhead Equipment (OHE) and power supply systems crucial for electric locomotive operations. Vijayawada Divisional Railway Manager (DRM) Narendra A Patil lauded the achievement, crediting the Senior Divisional Electrical Engineer and the TRD team for their dedication. 'This certification is not just recognition but a pledge to uphold safety and quality for seamless rail services,' Narendra A Patil said. The achievement reflects the division's ongoing focus on safety, reliability, and excellence, setting a benchmark within the SCR zone and reinforcing its leadership in modern railway infrastructure.
Hans India
2 days ago
- Business
- Hans India
Traction distribution dept achieves ISO 9001:2015 certification
Vijayawada: In a significant first for Indian Railways, the Traction Distribution Department of South Central Railway's Vijayawada Division has been awarded the ISO 9001:2015 quality management system certification. This landmark achievement was announced by Narendra A Patil, Divisional Railway Manager (DRM) of Vijayawada Division. The comprehensive certification spans 22 strategic locations within the division, encompassing all TRD depots, TRD offices, and the TRD store. It recognises the department's unwavering commitment to the quality maintenance of Overhead Equipment (OHE) and vital power supply installations, both of which are critical for the safe and efficient operation of electric locomotives. The certification was granted by QRO Certifications, a renowned certification body, through Harsha Technologies of Hyderabad. This followed a series of stringent and thorough audits that meticulously assessed the quality and consistency of the TRD Department's service delivery. 'This milestone makes Vijayawada Division the first division in Indian Railways to secure ISO 9001:2015 certification for its entire TRD Department,' stated the announcement. Speaking on this momentous occasion, DRM Narendra A Patil extended his heartfelt congratulations to Ch Dinesh Reddy, senior divisional electrical engineer and the entire traction distribution department team. He lauded their exemplary dedication and sustained efforts in elevating service standards. 'This certification is not just a recognition — it's a responsibility to maintain the highest quality and safety standards for uninterrupted passenger services across the Division,' added the DRM.
Business Wire
2 days ago
- Business
- Business Wire
Alto Neuroscience Announces Acquisition of Novel Dopamine Agonist Combination Product Candidate, Adding Late-Stage Readout in Treatment Resistant Depression Within Current Cash Runway
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Alto Neuroscience, Inc. ('Alto') (NYSE: ANRO), a clinical-stage biopharmaceutical company focused on the development of novel precision medicines for neuropsychiatric disorders, today announced that it entered into an asset purchase agreement with Chase Therapeutics Corporation for a portfolio of potentially best-in-class dopamine agonist drug combinations, including ALTO-207, formerly known as CTC-501, for treatment resistant depression (TRD), generally defined as a failure on two or more antidepressants. The most advanced program, ALTO-207 (formerly known as CTC-501), is a fixed-dose combination of pramipexole, a dopamine D3-preferring D3/D2 agonist, approved for the treatment of Parkinson's disease with demonstrated antidepressant effect, and ondansetron, an antiemetic, selective 5-HT3 receptor antagonist. As a fixed-dose combination, ALTO-207 is designed to enable rapid titration and higher dosing by mitigating the dose-limiting adverse events typically experienced with pramipexole. ALTO-207 is being developed to address the significant unmet need for patients with TRD. 'The expansion of our pipeline aligns with Alto's mission to drive innovation in psychiatry through novel therapeutic solutions,' said Amit Etkin, M.D., Ph.D., founder and chief executive officer of Alto Neuroscience. 'With proprietary insights on dopamine biomarkers in depression that enable targeted neuropsychiatric drug development, we are uniquely positioned to advance ALTO-207, a differentiated, late-stage product candidate with robust clinical effects to date, which are supported with historical pramipexole data. The fixed-dose combination of pramipexole and ondansetron offers a novel treatment strategy designed to optimize for a rapid treatment effect with faster titration, and balance safety and tolerability at high doses. We believe the convenience of a single prescribable agent will also improve compliance and support clinician and patient adoption. Leveraging our targeted biomarker approach to stratify for TRD patients most likely to respond to treatment, we look forward to building on the positive Phase 2a results and initiating a Phase 2b trial, with a potentially pivotal design, by mid-2026.' Dr. Etkin continued, 'The strategic transaction with Chase Therapeutics allows us to add a major late-stage clinical readout to our pipeline without changing our current cash runway guidance into 2028. Broadly, we believe this opportunity underscores the robust value of our precision platform and bolsters our prospects for long-term growth through driving innovation in psychiatry.' Thomas Chase, M.D., President and Chief Executive Officer of Chase Therapeutics Corporation, added, 'Supported by the robust clinical effects in our completed Phase 2a study, we believe CTC-501, has the potential to address the critical need for more effective, mechanistically distinct interventions for patients with TRD. Given Alto's expertise in dopamine-related products in depression, we believe they are an ideal partner to maximize the therapeutic potential of our portfolio in depression and Parkinson's disease. We look forward to seeing Alto continue this exciting momentum as they work toward realizing our shared vision for patients.' Michael Browning, DPhil, MRCP, MRCPsych, Professor of Computational Psychiatry, University of Oxford, commented, 'I am highly encouraged by the recently completed PAX-D study of pramipexole, which suggests a greater and more durable effect than other available TRD treatments. However, pramipexole is not well tolerated and when it is, it requires slow titration due to dose-limiting AEs. The clinical utility of pramipexole would be greatly enhanced by improving the dose-limiting tolerability profile. Emerging data suggests that ALTO-207 could address these challenges, and be well positioned to treat this large and underserved patient population.' Alto acquired CTC-501 (now ALTO-207), in development for depression, and CTC-413 (now ALTO-208), in development for Parkinson's disease. Both product candidates are novel patent-protected dopamine agonists. About the Completed Phase 2a Trial for CTC-501 Chase Therapeutics completed a randomized, placebo-controlled Phase 2a clinical trial evaluating CTC-501 in 32 patients with depression. The study consisted of two periods, a dose titration period in which patients were dosed with increasing dose levels of CTC-501 or placebo at increments of 1 mg/day (or matching placebo) until the maximum allowed dose (or first intolerable dose) was reached. Patients were then maintained for an eight-week treatment period at either the maximum allowed dose or their maximum tolerated dose (1 mg/day lower than their first intolerable dose in the titration period). The primary endpoint in the study was defined as overall tolerability and achievement of higher dose levels of pramipexole when combined with ondansetron. Clinical efficacy was evaluated as a secondary exploratory endpoint in the study. The primary endpoint was achieved in the study. Patients randomized to receive CTC-501 reached a mean dose of 4.1mg per day with 67% of patients achieving the highest allowable dose of 5mg/day. CTC-501 was generally well tolerated in the maintenance period of the study. The clinical efficacy measures were evaluated as secondary endpoints and across measures CTC-501 demonstrated large, clinically meaningful, effects. CTC-501 demonstrated statistically significant and clinically meaningful improvements from baseline compared to placebo on depression symptoms as measured by the Montgomery Åsberg Depression Rating Scalef, or MADRS (LSM Δ vs. placebo at Week 8 = -8.2, p=0.025, Cohen's d=1.1). CTC-501 also demonstrated a significantly greater improvement compared to placebo on the Clinician Global Impression Scale of Severity, or CGI-S (LSM Δ vs. placebo at Week 8 = -0.76, p=0.04, Cohen's d=1.0). About the Completed Phase 2a Trial for CTC-413 ALTO-208 is a fixed-dose combination of pramipexole and aprepitant, an antiemetic, neurokinin-1 (NK-1) receptor antagonist. ALTO-208 is being developed for patients with Parkinson's disease (PD). Chase Therapeutics completed a blinded Phase 2a clinical trial evaluating CTC-413 (pramipexole co-administered with aprepitant) in 13 patients with PD. The study consisted of two periods. Patients in the treatment group were initially titrated to the maximum allowed dose of standard pramipexole extended release (4.5 mg/day). Patients were then switched to CTC-413 until the maximum allowed dose of 9mg/day (or first intolerable dose) was reached. Following three months of maintenance, patients returned to their pre-study regimen for final assessment. The mean tolerated dose of CTC-413 significantly exceeded pramipexole (p<0.001). Six subjects (67%) tolerated CTC-413 at the maximum dose of 9.0mg/day and all but one remained on that dose throughout the final three-month treatment period. CTC-413 demonstrated favorable safety and tolerability with no unexpected, serious or persistent issues. About the Transaction Under the terms of the asset purchase agreement, Alto paid Chase Therapeutics an upfront payment of $1.75 million, and Chase Therapeutics will be eligible for up to an aggregate of $71.5 million in future milestone payments related to prespecified development and commercial milestones. $41 million of the potential future milestone payments are tied to commercial success of the product candidates. Alto's financial guidance remains unchanged. The Company expects its current cash balance to support planned operations into 2028, now through five clinical trial readouts across its pipeline programs. Conference Call and Webcast at 8:00 a.m. ET Today Alto Neuroscience will host a conference call today at 8:00 a.m. ET to discuss the acquisition of a novel dopamine agonist combination product candidate. The call will feature Michael Browning, Professor of Computational Psychiatry at the University of Oxford, and Alan Schatzberg, M.D., Professor of Psychiatry and Behavioral Sciences at Stanford University. To listen to the live webcast, please visit Alto's investor relations website. Participants may register for the call here. A replay of the webcast will be available following the conclusion of the live call and will be accessible on the Company's website. About Alto Neuroscience Alto Neuroscience is a clinical-stage biopharmaceutical company with a mission to redefine psychiatry by leveraging neurobiology to develop personalized and highly effective treatment options. Alto's Precision Psychiatry Platform™ measures brain biomarkers by analyzing EEG activity, neurocognitive assessments, wearable data, and other factors to better identify which patients are more likely to respond to Alto product candidates. Alto's clinical-stage pipeline includes novel drug candidates in bipolar depression, major depressive disorder, treatment resistant depression (TRD), and schizophrenia, and other mental health conditions. For more information, visit or follow Alto on X. Forward-Looking Statements This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as 'expects,' 'plans,' 'will' and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding Alto's expectations about the potential benefits, activity, effectiveness and safety of its product candidates and Precision Psychiatry Platform ('Platform'); Alto's expectations with regard to the design and results of its clinical trials; the reproducibility of positive clinical data seen in prior trials of CTC-501/ALTO-207; Alto's clinical and regulatory development plans for ALTO-207; the competitive landscape and potential market opportunities for ALTO-207; and Alto's anticipated cash runway. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including uncertainties inherent in the initiation, progress and completion of clinical trials and other important factors, any of which could cause Alto's actual results to differ from those contained in the forward-looking statements, which are described in greater detail in the section titled 'Risk Factors' in Alto's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the Securities and Exchange Commission ('SEC') as well as in other filings Alto may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Alto expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as required by law. Availability of Information on Alto's Website Alto routinely uses its investor relations website to post presentations to investors and other important information, including information that may be material. Accordingly, Alto encourages investors and others interested in Alto to review the information it makes public on its investor relations website.
Yahoo
14-05-2025
- Business
- Yahoo
Alar Pharmaceuticals Announces First Patient Dosing in a Study of ALA-3000 (Extended-Release Ketamine Injection) for Treatment-Resistant Depression (TRD)
TAICHUNG, May 14, 2025 /PRNewswire/ -- Alar Pharmaceuticals Inc. (Alar, TPEx:6785), a clinical-stage pharmaceutical company dedicated to the development of long-acting injectables to treat CNS disorders, today announced the dosing of the first patient in the multiple ascending study of subcutaneous extended-release Ketamine (ALA-3000) for Treatment-Resistant Depression (TRD) in the US. This phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple-dose study is planning to assess safety, tolerability, pharmacokinetics, and preliminary efficacy of ALA-3000 Injection in addition to standard of care in TRD patients. ALA-3000, developed by Alar Pharmaceuticals, is the first formulation of ketamine lasting over one week in the blood following single dose. It has been demonstrated in the animal model for more than one month of antidepressant effects. This innovative formulation aims to alleviate symptoms of TRD by delivering a stable, low level of ketamine. By doing so, it seeks to reduce common side effects associated with rapid-acting ketamine formulations, such as sedation, dissociation, dizziness, and anxiety. Designed with patient safety, compliance, and convenience in mind, ALA-3000 is expected to minimize the need for frequent clinic visits and prolonged on-site monitoring. This approach not only enhances the safety and durability of treatment but also aims to diminish the overall healthcare burden. "This first-in-human clinical trial of ALA-3000 marks a significant milestone in its development." said Yung-Shun Wen Ph.D., CEO of Alar. "This represents a novel treatment pattern, where prolonged exposure to low-level ketamine may further extend its antidepressant effects, providing patients with a more stable and longer-lasting therapeutic option." "Beyond offering patients a new treatment option, the development of ALA-3000 sustained-release injection also holds promise in mitigating the global trend of increasing off-label ketamine abuse." said Charles Lin, Founder and Chairman of Alar. For more information, please visit Alar's website at and for additional information. View original content: SOURCE Alar Pharmaceuticals Inc.
