- Predictive Interim analysis indicates low probability of study meeting its primary efficacy endpoint if continued
- Comprehensive analysis and evaluation of available open-label extension data will follow
- No safety concerns were identified in the interim analysis
PARSIPPANY, N.J., Nov. 02, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that it will discontinue the Phase 2 TOPAS-MSA study (NCT06568237) evaluating emrusolmin (TEV-'286) in adults with multiple system atrophy (MSA). The decision follows a recommendation from the independent data monitoring committee (IDMC), based on a prespecified interim futility analysis. The analysis met the predefined futility criterion, indicating a low probability of the study meeting its primary efficacy endpoint if continued. This was an interim predictive assessment and not the study's final efficacy analysis. No safety concerns were identified in the interim analysis.
Emrusolmin is being developed in partnership with MODAG GmbH. A comprehensive analysis of the TOPAS-MSA data and available data from the open-label extension study of emrusolmin in MSA (NCT07197866) will follow. The decision announced today concerns TOPAS-MSA and does not represent a final decision on the broader emrusolmin program.
"While we are disappointed by the outcome of this interim analysis for the Phase 2 study, we remain deeply committed to learning everything we can from these data," said Eric Hughes, M.D., Ph.D., Executive Vice President, Global R&D and Chief Medical Officer at Teva. "We are deeply grateful to the patients, families, investigators, and study teams who contributed their time and commitment to this research. Our hope is that the science and learnings can deepen our understanding of MSA and help us determine a path forward for emrusolmin."
Teva will work with the TOPAS-MSA study investigators to ensure the study protocols are followed while the Phase 2 study is discontinued. Teva plans to share the TOPAS-MSA findings with the scientific community following completion of its comprehensive analysis.
Teva to Host Q3 Earnings Call on November 3, 2026
Teva will host its third-quarter 2026 earnings conference call on November 3, 2026 at 8:00 a.m. ET. Register here. A live webcast of the call will be available on Teva's website at: https://ir.tevapharm.com/Events-and-Presentations.
About the TOPAS-MSA Program
TOPAS-MSA (NCT06568237; TV56286-NDG-20039) is a randomized, double-blind, placebo-controlled Phase 2 study designed to evaluate the efficacy and safety of emrusolmin in adults with multiple system atrophy (MSA). The study was designed to enroll approximately 350 participants to receive emrusolmin 300 mg or placebo for approximately 48 weeks, followed by a four-week follow-up period. The primary endpoint is change from baseline to Week 48 in the modified Unified Multiple System Atrophy Rating Scale Part I score.
The separate Phase 2 open-label extension (OLE) study (NCT07197866; TV56286-NDG-20041) is designed to evaluate the long-term safety and tolerability of emrusolmin in eligible participants who completed the 48-week treatment period of TOPAS-MSA.
About emrusolmin
emrusolmin, also known as TEV-'286, is an investigational, orally administered small molecule designed to target alpha-synuclein aggregation, one of the core pathogenic mechanisms believed to be involved in MSA. Emrusolmin is being developed in partnership with MODAG GmbH. The U.S. Food and Drug Administration granted Orphan Drug designation to emrusolmin for MSA in 2022 and Fast Track designation in September 2025.
About Multiple System Atrophy (MSA)
MSA is a rare neurodegenerative disorder classified clinically as "atypical parkinsonism" and belongs to the group of synucleinopathies. MSA is characterized histopathologically by abnormal deposits of the a-synuclein protein, mainly in oligodendroglial cells (glial cytoplasmic inclusions) and also in certain nerve cells. Typically, there is a dysfunction of the autonomic nervous system, i.e., disturbances of bladder function, erectile function, intestinal mobility, or the regulation of blood pressure in combination with a movement disorder. The movement disorder often presents with either Parkinson-like symptoms or a disturbance of cerebellar function, such as ataxia, gait and speech problems. In the US, EU, and Japan, MSA affects about 40,000 people (prevalence of 4 per 100,000), with about 6,000 new cases diagnosed each year (incidence of 0.6 per 100,000). Post-diagnosis life expectancy is about 6-10 years. Due to the relatively small number of affected patients and lack of effective therapy, MSA qualifies for orphan status, allowing a shorter development path. This unmet medical need for MSA disease modification is the driver to develop new therapies that could potentially impact the lives of patients.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva's commitment has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients' needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause Teva's future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. All statements other than statements of historical fact are, or may be deemed to be, forward-looking statements. In some cases, you can identify these forward-looking statements by the use of words such as "should," "expect," "anticipate," "developing," "target," "may," "expand," "intend," "plan," "believe" and other words and terms of similar meaning and expression in connection with any discussion of future performance. Important factors that could cause or contribute to such differences include risks and uncertainties relating to: our ability to develop emrusolmin (TEV-'286) for the treatment of MSA in adults; our ability to successfully compete in the marketplace including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to execute on our organizational transformation and to achieve expected cost savings; our significant indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the second quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned "Risk Factors," "Other Information" and "Cautionary Note Regarding Forward Looking Statements." Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
Teva Media Inquiries:
TevaCommunicationsNorthAmerica@tevapharm.com
Teva Investor Relations Inquiries:
TevaIR@Tevapharm.com
