- Breakthrough Part 2 Trial Outcomes Present Promise for Sufferers Ineligible for Normal Reperfusion Therapies
- Information Introduced at Worldwide Stroke Convention
- Information Present That LT3001 Delivers Significant Useful Enhancements in Sufferers Affected by Disabling Acute Ischemic Stroke (AIS)
TAIPEI, Feb. 6, 2026 /PRNewswire/ — Lumosa Therapeutics (Lumosa; 6535.TWO) in the present day introduced constructive outcomes from two unbiased Part 2 scientific trials with its novel stroke drug LT3001 (Odatroltide). LT3001 is a first-in-class dual-functional remedy that mixes secure reperfusion with direct neuroprotection, addressing key limitations of present acute ischemic stroke therapies. These knowledge revealed that LT3001 delivers significant practical enhancements in sufferers affected by disabling acute ischemic stroke (AIS), providing new hope for many who can not obtain commonplace reperfusion therapies. These knowledge have been reported right here in the present day on the Worldwide Stroke Convention in New Orleans.
The groundbreaking outcomes show LT3001’s potential to remodel outcomes for stroke sufferers dealing with restricted therapeutic choices. The novel therapeutic agent, which reinforces endogenous fibrinolysis and scavenges dangerous free radicals, confirmed notably spectacular ends in reasonable stroke sufferers with disabling signs. Within the LT3001-202 trial performed in China, reasonable stroke sufferers with disabling signs handled with LT3001 achieved 8% and 13% enhancements in modified Rankin Scale (mRS) scores of 0-1 and 0-2 respectively, in comparison with placebo.
Most remarkably, LT3001 confirmed enchancment in practical outcomes in LAA and mismatch-positive populations. In Examine 202, LAA sufferers (n=169) confirmed an 11% enchancment in mRS 0–2 and a 9% acquire in mRS 0–1. Examine 205 validated these indicators by way of imaging assisted choice, with mismatch-positive sufferers reaching a ten% absolute enchancment in mRS 0–2. These scientific advances might restore independence to hundreds of sufferers yearly.
The complementary LT3001-205 trial, spanning the US, EU, and Taiwan, utilized superior imaging-assisted affected person choice. Regardless of smaller pattern sizes, the trial strengthened LT3001’s efficacy indicators, with sufferers displaying disabling options reaching mRS 0-1 outcomes extra usually with LT3001 (27%) in comparison with placebo (17%).
“Throughout the 2 Part 2 trials, LT3001 demonstrated a good security profile, with no enhance in symptomatic intracranial hemorrhage (sICH) regardless of multi-dose administration over 3 days,” stated Thomas Devlin, MD, PhD, FSVIN, Director of the CHI Memorial Neuroscience Institute, Professor of Neurology Morehouse Faculty of Drugs and principal investigator of the LT3001-205 research. “LT3001 confirmed potential profit past the standard thrombolytic time window, supporting its use in sufferers ineligible for IV thrombolysis or EVT, a inhabitants with excessive unmet want. The consistency of outcomes throughout two unbiased trials, utilizing completely different choice methods, strengthens our confidence in LT3001’s broad applicability.”
Addressing a Essential Unmet Want
“Regardless of over 5 a long time of analysis and hundreds of potential drug targets, the event of neuroprotective medicine for circumstances like stroke has not resulted in any FDA-approved medicine within the U.S.,” stated Sheng-Wen Yeh (Mimi) Ph.D., common supervisor, Lumosa. “Whereas many medicine steadily achieve preclinical, animal-based research, they fail to point out security or efficacy in human trials. Our efficacy knowledge with LT3001, spanning numerous affected person populations, is thrilling and gives route for our Part 3 applications.”
Acute ischemic stroke impacts thousands and thousands globally, with many sufferers experiencing disabling signs that severely affect their high quality of life and independence. Present reperfusion therapies, whereas efficient, usually are not appropriate for all sufferers because of timing constraints, contraindications, or anatomical elements. LT3001’s distinctive twin mechanism – enhancing the physique’s pure clot-dissolving processes whereas defending mind tissue from oxidative harm – gives a brand new therapeutic pathway for these underserved sufferers.
The trials evaluated sufferers inside 24 hours of stroke onset, specializing in these with disabling signs outlined as important arm or leg motor impairment. This affected person inhabitants represents a considerable portion of stroke instances the place present remedy choices stay insufficient. Each Part 2 trials employed rigorous randomized, placebo-controlled methodologies, with LT3001-202 enrolling 297 sufferers and LT3001-205 together with 88 sufferers. The consistency of constructive indicators throughout completely different geographic areas and affected person choice standards underscores the robustness of those findings.
About LT3001
LT3001 (Odatroltide) represents an modern strategy to acute stroke remedy, focusing on each the thrombotic and oxidative parts of stroke pathophysiology. In contrast to conventional approaches that focus solely on clot removing, LT3001’s twin mechanism addresses a number of facets of stroke damage, doubtlessly extending the therapeutic window and broadening affected person eligibility.
The Firm is advancing LT3001 by complete scientific improvement, with plans for Part 3 trials to additional validate these promising ends in bigger affected person populations.
Subsequent Steps and World Growth Plans
These mixed Part 2 outcomes present vital scientific proof supporting the continued improvement of LT3001 for acute ischemic stroke. Of word, Lumosa lately acquired suggestions from the U.S. Meals and Drug Administration concerning its Part 3 improvement plans for LT3001.
Based mostly on this suggestions, Lumosa goals to speed up international Part 3 improvement of LT3001 and ship modern and efficient remedy choices for stroke sufferers worldwide.
About Acute Ischemic Stroke
In response to the World Well being Group (WHO), stroke is the second main reason for loss of life for folks over the age of 60 with roughly 6 million deaths on the planet per yr. Stroke may be categorized as hemorrhagic (bleeding) or ischemic (lack of blood move to vital areas of the mind). Research present ischemic stroke is most typical, occurring in about 85% of all stroke instances. Stroke is notably a illness with important international unmet medical want. There are 15 million folks worldwide who are suffering a stroke annually. As a result of solely surgical procedure and restricted therapeutic choices are at present accessible, 80% of stroke sufferers are left with no different remedy choices or with out desired outcomes.
About Lumosa
Lumosa Therapeutics, Inc. (https://www.lumosa.com.tw/) is a clinical-stage pharmaceutical firm devoted to the event of novel therapies and options for neurologic ailments with pressing unmet medical want. Along with using its personal know-how platform, the Firm can also be actively engaged in scientific licensing and co-development collaboration — constructing a pipeline from early to late-stage belongings consisting of first-in-class and best-in-class medicine. Lumosa’s mission is to counterpoint sufferers’ high quality of life by pioneering medical science, numerous collaborations, and a dedication to stay real and ever-evolving. Central to this mission is the Firm’s goal to develop its novel small molecule, LT3001, for the remedy of acute ischemic stroke, a medical illness for which more practical therapies are tremendously wanted.
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