SAN FRANCISCO, Calif., May 22, 2025 (GLOBE NEWSWIRE) — Endurance Bio Inc., a clinical-stage biotechnology company developing therapies for neurodegenerative and metabolic diseases, today announced that its compound, T-168, has been selected for testing on the SLEIPNIR clinical trial platform for Parkinson’s disease (PD), an academic, investigator-led initiative at the Neuro-SysMed Centre of Excellence for clinical treatment research in neurology, in Bergen, Norway.
SLEIPNIR is a pioneering, multi-arm, Phase 2a, randomized, placebo-controlled clinical trial platform designed to rigorously assess target penetration and engagement of candidate therapies in early-stage clinical development for PD. SLEIPNIR will operate through iterative cycles of trials, each of which will test three independent treatments versus a shared placebo group. Based on state-of-art fluid and neuroimaging biomarker analyses, treatments will be nominated for advancing to larger trials assessing clinical efficacy. In this manner, SLEIPNIR allows to prioritize therapies with verified brain penetration and biological activity for further development. SLEIPNIR is supported by Cure Parkinson’s, the Norwegian Parkinson’s Research Fund and the Norwegian Parkinson’s Association.
T-168 was chosen for its novel mechanism of action, which involves upregulation of PGC-1α and TFEB to restore mitochondrial and lysosomal function, key processes implicated in the pathophysiology of PD and other neurodegenerative diseases. This approach directly addresses the urgent need for new therapeutic strategies in PD, where more than 70 randomized clinical trials have failed to deliver a compound capable of halting disease progression.
Professor Charalampos Tzoulis, MD, PhD, Director of the Neurodegeneration Program of the Neuro-SysMed Center and Professor of Neurology at Haukeland University Hospital and the University of Bergen, stated: “Endurance Bio’s T-168 stands out as a highly promising compound in clinical development for PD and other neurodegenerative disorders. Its mechanism, which upregulates PGC-1α and TFEB to restore mitochondrial and lysosomal function, addresses fundamental disease processes. By including T-168 in the SLEIPNIR platform trial, we aim to rigorously evaluate its potential to influence key-disease mechanisms in the patient brain. A positive outcome from this trial will directly nominate T-168 for testing of clinical efficacy in a Phase 2b/3 trial and bring new hope to patients worldwide”.
Frederic Godderis, CEO of Endurance Bio Inc., added:
“We are excited to collaborate with Professor Tzoulis and his team to unlock the therapeutic potential of PGC-1α and TFEB upregulation for patients with Parkinson’s disease. The SLEIPNIR study will be instrumental in advancing the clinical development of T-168 in PD and other neurodegenerative diseases. This partnership represents a significant step forward in our mission to deliver transformative treatments to patients”.
PD is one of the most common and debilitating brain diseases. It affects approximately 10 million people globally. The SLEIPNIR trial is expected to set a new standard for early-phase clinical research in PD by prioritizing therapies with robust biological rationale and measurable target engagement.
About Endurance Bio Inc.
Endurance Bio Inc. is a California-based clinical-stage biotech company developing orally bioavailable small molecules that restore mitochondrial and lysosomal health by upregulating PGC-1α and TFEB, master regulators of cellular metabolism. Founded on discoveries from Dr. Edgar Engleman at Stanford University, Endurance Bio’s lead compound, T-168, is in clinical Phase 2, with additional assets in preclinical development. The mechanism of action has demonstrated broad therapeutic potential not only in neuroscience, but also in metabolic, cardiovascular, and inflammatory disease areas. Endurance Bio is seeking partners and investors to advance its innovative pipeline.
This press release contains forward-looking statements regarding investigational therapies and clinical research. Actual results may differ due to risks and uncertainties inherent in drug development.
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