GAIA AG

WALTHAM, Mass., May 29, 2024 /PRNewswire/ -- The iConquerMS™ People-Powered Research Network (PPRN) (), a research initiative of the Accelerated Cure Project (ACP), is partnering with the Department of Veterans Affairs (VA), the digital therapy company GAIA AG, Charité – Universitatsmedizin Berlin, the University Medical Center Göttingen, and Ordinal Data, Inc., on a four-year, large-scale clinical trial of online programs, or digital therapeutics, for treating fatigue in multiple sclerosis (MS). This trial is funded by a nearly $4.5 million grant from the Department of Defense (DoD) Congressionally Directed Medical Research Programs (CDMRP), Multiple Sclerosis Research Program (MSRP). Continue Reading For many people living with MS, fatigue is a common symptom that limits their ability to engage in regular everyday activities. Affecting about 70 percent of people with MS (PwMS), it accounts for a substantial portion of the disability and psychosocial burden of this disease. While medication-based treatments have had mixed results in studies and carry risks of side effects, analyses of a number of smaller studies show treatment with non-pharmacological approaches may be effective and safe. The clinical trial will assess the effectiveness of two online programs and will be conducted with the goal of gaining FDA approval of a novel, non-pharmacological therapy for fatigue in MS. Although they differ, both of these online programs contain potentially useful information about MS and fatigue intended to help PwMS understand and manage their fatigue. The large-scale, decentralized clinical trial is projected to enroll 2,000 PwMS. The collaboration between iConquerMS and 5 VA sites in the MS Centers of Excellence is designed to ensure sufficient representation of PwMS from populations traditionally under-represented in MS clinical trials in order to increase generalizability of the study results. "Fatigue is often the most difficult symptom to manage and the community of people with MS is particularly excited to know this study may provide compelling evidence for a non-pharmacological treatment accessible to everyone. We look forward to testing these online programs through a highly inclusive clinical trial to determine if this will be a successful fatigue treatment option," says Laura Kolaczkowski, Lead Patient Representative for iConquerMS. GAIA, Charité, and the University Medical Center Göttingen recently completed a successful 275-patient trial of an online program for fatigue in PwMS recruited via the German MS Patient Organization website. That trial showed significant reductions in fatigue measures among the group using that online program in addition to their usual MS treatment compared to the group who received just their usual MS treatment, and no safety concerns were found for the online program. That online digital therapeutic is now approved by German regulatory authorities and covered by health insurance. An American English version of that program is one of the programs being tested in the US study. The US study will be a 3-arm, randomized controlled clinical trial with study participation lasting 1 year. Two of the trial arms will include one of two online programs for fatigue in MS added to the trial participants' usual MS treatment, and the third arm will include usual MS treatment alone. The online program phase of the trial lasts for 6 months after randomization followed by a final study visit at 12 months. Participants in the usual MS treatment alone arm for the first 6 months will have an opportunity to choose one of the online programs for the final 6 months of the trial. Recruitment is expected to open in Summer 2024 for the iConquerMS network and Fall 2024 for the VA sites. "Fatigue can be very debilitating for many people with MS, so finding therapies to manage this symptom is critical," says co-lead investigator Robert McBurney of ACP. "Non-pharmacological, scalable treatments could be life-changing for many people with MS, especially those who live in rural communities or experience other barriers to more invasive medical treatments or in-person sessions. We hope this largest-ever and most-diverse clinical trial of online treatments for fatigue in MS will definitively demonstrate the benefits [of this online therapeutic] for people with MS from a wide variety of backgrounds." iConquerMS is a patient-powered research network made up of people affected by MS—those who have MS, those who care for them, researchers, clinicians, advocates, and more—who are working together to learn more about the disease and its effects and to find treatments for MS and its symptoms. This study is one of many iConquerMS has undertaken in partnership with researchers around the world to collect important data and provide insights that can improve life for those living with MS. About Accelerated Cure Project ACP () is a patient-founded non-profit organization dedicated to accelerating research efforts to improve the health, healthcare and quality of life of people affected by MS. The organization promotes scientific collaboration and accelerates research by rapidly and cost-effectively providing researchers worldwide with people, data, and biosample resources they need to explore novel research ideas that can lead to cures and better care for people living with MS. The major programs of ACP are the ACP Repository, the iConquerMS™ People-Powered Research Network, the Research Inclusivity, Diversity and Equity Council, and the MS Minority Research Engagement Partnership Network. About the iConquerMS People-Powered Research Network iConquerMS™ () is a research initiative by and for individuals living with MS who contribute their ideas and their health data. iConquerMS™ was established in 2014 by the Accelerated Cure Project , in partnership with Feinstein Kean Healthcare and Arizona State University. Initial funding for iConquerMS™ was provided by the Patient-Centered Outcomes Research Institute (PCORI) (). Over 8,000 individuals living with MS are currently registered as iConquerMS™ research participants, constituting a large and growing cohort for data-driven research into topics that matter most to people affected by MS. iConquerMS™ achieves its purpose, to improve the health, healthcare and quality of life of people affected by MS, through collaborations with U.S. and international academic, government, and industry organizations. About the U.S. Department of Veterans Affairs Multiple Sclerosis Centers of Excellence The Department of Veterans Affairs (VA) Multiple Sclerosis Centers of Excellence (MSCoE) are dedicated to furthering the understanding of multiple sclerosis (MS) in military Veterans, and ensuring access to effective treatments to help manage MS and its associated symptoms. By partnering with Veterans, caregivers, health care professionals, MS advocates, Veteran service organizations, and community health care institutes, the MSCoE strives to minimize impairment and maximize quality of life for Veterans with MS. The Department of Veterans Affairs actively manages approximately 20,000 Veterans with MS each year. VA MSCoE sites participating in this study include Baltimore, Washington, DC, Nashville, Portland, and Seattle. About GAIA GAIA is the global pioneer and leader in the research and development of evidence-based, fully automated digital therapeutics (DTx). For more than 25 years, the company has combined science, technology, and therapeutic excellence under one roof. With over 250 employees at the two research sites in Germany and the USA, GAIA is helping to shape the future of healthcare by providing fully automated, effective, and safe therapeutics for patients suffering from some of the most common and debilitating chronic diseases such as depression, multiple sclerosis and rheumatoid arthritis around the world. In Germany alone, GAIA has seven DTx that are generally reimbursed. In almost 30 randomized controlled trials as well as in various clinical settings in Europe, South America, and the USA, GAIA's products have proven their efficacy, effectiveness, and safety. For more information, please visit About Charité – Universitätsmedizin Berlin Charité – Universitätsmedizin Berlin is one of Europe's largest university medical centers, where the areas of research, teaching, and medical and patient care are closely interconnected. Charité is one of the capital city's largest employers where over 5,200 staff in research and medicine provide care for more than 125,000 inpatients and day case patients and about 740,000 outpatients per year. About the University Medical Center Göttingen (UMG) The University Medical Center Göttingen (UMG) unites the Medical Faculty of the Georg-August University and the University Hospital under one roof. In addition to research and teaching, patient care is the third central focus of the UMG. With around 1,600 inpatient and day-care beds, the hospital is the only maximum care facility in southern Lower Saxony. With almost 9,700 employees, the UMG and its subsidiaries are one of the largest employers in the region. All basic medical disciplines are represented in around 60 clinics, institutes, and departments, as well as a wide range of specialist medical disciplines in diagnostics and therapy. Every year, the UMG treats around 60,000 inpatients and around 220,000 outpatients. About Ordinal Data, Inc. Ordinal Data, Inc., is a highly experienced team of information technology professionals energized by opportunities to accelerate improvements in healthcare and research. They develop, integrate, and apply innovative information technology to accelerate clinical research, nurture patient communities, improve health care quality and comparative effectiveness, and to gain better insights and efficiencies in the management of research programs. About the MSRP Established by the U.S. Congress in fiscal year 2009, the MSRP supports innovative and impactful research that addresses fundamental issues and gaps in multiple sclerosis. The MSRP received appropriations totaling $153.1 million since the inception, including $20 million in 2024. For more program information including funding opportunities, please visit the program site, . In FY24, the CDMRP received over $1.5 billion in congressional appropriations for research dedicated to improving the health of Service Members and their Families, Veterans, and the American public. This funding targets critical gaps in research by focusing on innovative, high impact projects that will lead to cures or improvements in patient care, breakthrough technologies and resources for clinical benefits. Disclaimer The project is supported by the Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense, in the amount of $4,478,480, through the MSRP under Award No. HT9425-23-1-0482. Opinions, interpretations, conclusions, and recommendations are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the Department of Defense. Media Contact: Melissa Glim, [email protected] SOURCE Accelerated Cure Project for Multiple Sclerosis

The six-month randomized controlled trial (RCT) enrolled 437 participants at 36 sites across the US The study demonstrated no statistically significant difference between treatment arms in any pre-specified endpoint Both treatment arms had unexpectedly high rates of treatment response, with no adverse events associated with the use of MODIA A post hoc analysis found that patients completing all 24 modules of MODIA had a significantly higher treatment response than those who did not complete the entire program Orexo will continue to commercialize MODIA as a mobile medical device subject to FDA enforcement discretion UPPSALA, Sweden, Oct. 11, 2023 /PRNewswire/ -- Orexo AB (publ.), (STO: ORX) (OTCQX: ORXOY), today reports top line results after having completed a study evaluating the efficacy of MODIA in combination with sublingual buprenorphine/ naloxone for the treatment of opioid use disorder (OUD) and reduction in use of illicit opioids. The study had unexpectedly high treatment response rates for both treatment arms, with no statistically significant difference in treatment response in the full population. No adverse events associated with the use of MODIA were reported. An exploratory analysis of patients randomized to MODIA found that those who completed all 24 modules had a significantly higher rate of treatment response than those who did not complete the entire program. A comprehensive Medication-Assisted Treatment (MAT) approach that combines medications for OUD with psychosocial support is recommended for optimal outcomes. Education of patients with OUD is critical to help them understand their disease, their treatment, and strategies to support their recovery.[1] As a browser-based digital program that can be accessed remotely at any time, MODIA provides flexible access to educational content and exercises that are based on cognitive behavioral therapy principles. The study was a randomized, open-label, parallel-group study, enrolling patients aged 18 to 65 across the US who voluntarily sought treatment for documented moderate to severe OUD. Participants were inducted and stabilized on buprenorphine/naloxone during a brief screening period, then evaluated during weekly visits over the course of 24 weeks, with a primary endpoint defined as the subject having ≥80 percent of urine drug tests negative for illicit opioids and negative self-reports for illicit opioid use during the final 20 weeks of the study. Patients were randomized to receive weekly medication management i.e., background study care (BSC), or BSC in addition to MODIA. Subjects were compensated for attending study visits. The study enrolled 437 patients at 36 centers across the US. Study completion rates were similar (55% BSC, 52% MODIA), as were treatment response rates (32% BSC, 31% MODIA). There was no statistically significant difference between treatment arms in any pre-specified endpoint of the study. These unexpectedly high treatment response rates exceeded those of similarly designed trials of long-acting injectable buprenorphine, which had 18 and 24 study visits (17% and 29%, respectively)[2],[3]. An exploratory analysis of the 219 patients randomized to MODIA who subsequently completed the entire study (n=114), found that the 61 patients that completed all 24 modules of MODIA had a significantly higher treatment response rate of 61% than those that did not complete the entire program (n=53), who had a treatment response rate of 38% (p=0.0146). The difference in treatment response rate emerged after completion of 12 modules. In addition, the study showed indications of improved psychosocial outcome for those who completed MODIA which will be explored further in continued post hoc analysis. MODIA is designed to educate patients on behavioral changes that can support their recovery journey, and to empower them with techniques to help them cope with the challenges of everyday life. To support the patients' healthy recovery, adherence to the program is important and Orexo will work with the developer of MODIA, GAIA AG to add functionality to MODIA to further improve adherence. In the study 38% of patients reported at least one adverse event. Overall reporting of adverse events was similar between treatment arms, and no adverse events associated with the use MODIA were reported. Nikolaj Sørensen, President and CEO of Orexo AB, said, "Addressing the unmet need for psychosocial support in the treatment of OUD patients is part of our commitment to the treatment community. This study had a surprisingly positive treatment outcome in both arms compared to previous studies with similar designs and care as usual. To meet the requirements of the authorities of weekly tests for illicit drugs, our study compensated patients for attending weekly visits, which does not reflect typical care for OUD. Both frequent medication visits and compensation to patients can improve treatment response rates[4],[5]. For MODIA we saw indications that the benefits from the therapy increased with completion of the entire program, and we remain enthusiastic about the potential for MODIA to support patients with OUD in their recovery journey." The company will continue to commercialize MODIA with limited changes as a mobile medical device subject to FDA enforcement discretion following the expected expiration of the COVID Public Health Emergency Guidance in November 2023. Under enforcement discretion MODIA will be positioned as a supportive resource for patients undergoing a clinician-directed treatment, rather than as a physician-prescribed treatment regimen. The study results indicate there is high value in the combination of high frequency interactions with health care providers and completion of the MODIA program, as well as MODIA's strong safety profile. The company is continuing to analyze the study data and will continue to collect data to show the value of MODIA in supporting the patients with OUD to get their lives back. For further information please contact: Orexo AB (publ.) Nikolaj Sørensen, President and CEO Tel: +46 (0)18 780 88 00 E-mail: [email protected] Lena Wange, IR & Communications Director Tel: +46 (0)18 780 88 00 E-mail: [email protected] About MODIA MODIA is a web-based software program intended to help OUD patients develop behavioral coping skills and provide educational information, reminders, and motivational guidance. MODIA is intended for use by patients engaged in a clinician directed Medication-Assisted Treatment (MAT) plan for OUD. In addition, MODIA supports users as they work with their clinician on a recovery plan based on the responses collected from the exercises throughout the program. Orexo owns the global commercial rights to MODIA. About Orexo Orexo develops improved pharmaceuticals and digital therapies addressing unmet needs within the growing space of substance use disorders and mental health. The products are commercialized by Orexo in the US or via partners worldwide. The American market for buprenorphine/naloxone products is the largest, where Orexo commercializes its lead product ZUBSOLV® (buprenorphine and naloxone) sublingual tablets (CIII) for treatment of opioid use disorder. Total net sales for 2022 amounted to SEK 624 million and the number of employees was 126. Orexo is listed on the Nasdaq Stockholm Main Market (ORX) and is available as ADRs on OTCQX (ORXOY) in the US. The company is headquartered in Uppsala, Sweden, where research and development activities are performed. For more information about Orexo please visit . You can also follow Orexo on X, @orexoabpubl, LinkedIn, and YouTube. The information in the press release is information that Orexo is obliged to make public pursuant to the EU Market Abuse Regulation. The information was sent for publication, through the agency of the contact person set out above, on October 11, 2023, at 8 am CET. [1] American Society of Addiction Medicine: J Addict Med. 2020 Mar/Apr;14(2S Suppl 1):1-91. doi: 10.1097/ADM.0000000000000633. [2] Lofwall MR et al, JAMA Intern Med. 2018;178(6):764-773. doi:10.1001/jamainternmed.2018.1052 [3] Haight BR et al, Lancet. 2019:393:778-790. doi:10.1016/S0140-6736(18)32259-1 [4] Carroll KM et al. Am J Psychiatry 2017;174:738-747. doi:10.1176/appi.ajp.2016.16070792 [5] Galanter M et al, Am J Addictions 2020;29:271-278 The following files are available for download: SOURCE Orexo