#Taiwan #Taipei #Lumosa Therapeutics #LT3001 #Acute Stroke

Positive Advancements in Stroke Treatment with LT3001

Lumosa Therapeutics has recently announced significant outcomes from its Phase 2b clinical trial (LT3001-202) involving its innovative therapy, LT3001 (intravenous Odatroltide), specifically for patients experiencing acute ischemic stroke. The results were presented by Dr. Shuya Li, Chief Neurologist at Beijing Tiantan Hospital, during the 17th World Stroke Congress held in Barcelona, Spain. This study involved 34 medical centers across China and showcased promising data, suggesting that LT3001 may provide substantial clinical advantages compared to existing treatment protocols.

Study Findings

The primary endpoint of the trial was to evaluate safety, and LT3001 effectively achieved this goal without any instances of symptomatic intracranial hemorrhage (sICH). Importantly, the study demonstrates that LT3001 can be administered within a window of up to 24 hours after the onset of stroke symptoms, a notable improvement over the current standard care offering, which allows for treatment only within 4.5 hours.

The data indicates that patients receiving LT3001 displayed increased rates of functional independence, notably achieving a 7.3% higher rate by day 90 compared to those assigned a placebo. Moreover, LT3001 showed consistent efficacy trends across different patient groups:

• - Patients with moderate strokes showed a 9% improvement in functional independence (mRS 0–1 and mRS 0–2).
• - In severe strokes, the high-dose group achieved positive outcomes with a 4% increase (mRS 0–1) and a 12% gain (mRS 0–2).
• - Among those with large artery atherosclerosis, improvements reached 9% (mRS 0–1) and 11% (mRS 0–2).
• - For patients with motor drift affecting their arms, there was a 24% improvement (mRS 0–1) and a 21% improvement (mRS 0–2), while leg motor drift patients saw a 14% and 12% improvement, respectively.

These findings underline the potential of LT3001 as a viable treatment pathway, especially for patients who are not appropriate candidates for current reperfusion therapies.

Merging Thrombolytic and Neuroprotective Properties

Dr. Shuya Li commented on the results, emphasizing that LT3001 combines both thrombolytic and neuroprotective mechanisms, reflecting its strong potential as a treatment option. As Professor Yongjun Wang noted, who led the study, this data paves the way for advancement into global Phase 3 trials.

In a separate but related global Phase 2 study (LT3001-205) conducted in the US, Europe, and Taiwan, similar positive trends were noted, thereby reinforcing the efficacy results observed in the China trial without any reported adverse sICH.

Future Directions

The Phase 2 results provide crucial clinical data that supports the ongoing development of LT3001 for acute ischemic stroke. Lumosa is strategically collaborating with Shanghai Pharma and initiating global licensing discussions with international pharmaceutical partners to propel the Phase 3 clinical trials for LT3001. The company's ambition is to expedite the introduction of this innovative therapy to address the pressing demand for effective options in stroke treatment.

Addressing Global Stroke Challenges

According to the World Health Organization, strokes remain a leading cause of mortality worldwide, with ischemic strokes comprising approximately 85% of all cases. The current treatment options are limited, leaving many patients without effective remedies. Lumosa’s LT3001 represents a pioneering advancement in this field, offering hope to millions who suffer from this devastating condition.

As Lumosa Therapeutics continues its dedication to developing effective neurological therapies, LT3001 stands at the forefront of innovation for treating acute ischemic stroke, potentially altering how the medical community approaches this critical health crisis.