HOME - LATEST NEWS - Corporate - Lumosa Therapeutics Announces FDA Clearance of IND Application Its LT3001, a New Drug for the Treatment of Acute Ischemic Stroke, for Multi-dose Phase 2 Trial in Combination with Mechanical Thrombectomy





Lumosa Therapeutics Announces FDA Clearance of IND Application Its LT3001, a New Drug for the Treatment of Acute Ischemic Stroke, for Multi-dose Phase 2 Trial in Combination with Mechanical Thrombectomy

(September 16, 2021, Taipei) Lumosa Therapeutics (Lumosa; code: 6535.TWO) today announced the clearance from the US FDA for a multi-dose Phase 2 trial of LT3001, a novel treatment for acute ischemic stroke (AIS), in combination with mechanical thrombectomy. The company is also expecting to complete the Investigational New Drug (IND) application with Taiwan FDA (TFDA) by the end of this year.

Lumosa CEO Mr. Rongjin Lin expressed: “stroke has extremely high mortality and disability rates, however, medical options are currently very limited; there has not been a new drug for the treatment of AIS released for more than 20 years. The global medical community is eager to end the threat caused by stroke to human health and LT3001 is maybe the hope. Lumosa has initiated a development program to accelerate licensing from international pharmaceutical companies. We expect LT3001 to meet this urgent medical need by breaking through safety limitations and expanding the patient population so that patients with less than 24 hours of stroke onset may benefit.”

According to the World Health Organization (WHO), there are 15 million people worldwide who suffer a stroke each year and 85% are ischemic strokes (due to thromboembolism in the brain). Although standard care such as rt-PA thrombolytic (administered intravenously) and mechanical thrombectomy are available, the former has a higher risk of intracranial hemorrhage and can only be used within 3/4.5 hours of stroke onset while the latter fails to achieve a satisfactory therapeutic effect in half of the stroke patients. Due to the above safety and technical restrictions, 80% of stroke patients are still left with no other treatment options or without desired outcomes. If it is able to resolve current therapeutic limitations, LT3001 may satisfy the current treatment gap capable of reaching USD 10.6 billion in market potential.

LT3001 represents a novel drug designed for the treatment of acute ischemic stroke. A single-dose Phase 2a clinical trial showing both thrombolytic and neuroprotective properties was completed in August this year in the U.S. and Taiwan. According to the trial data, no evidence of increased risk of symptomatic intracranial hemorrhage (sICH) was observed in acute ischemic stroke patients with less than 24 hours onset who were treated with LT3001. The drug is expected to increase the treatment ratio in stroke patients as more subjects achieved excellent functional outcome and pronounced neurological improvement in the study. 

Motivated by the study results, Lumosa believes that under the premise of LT3001’s safety profiles, an opportunity to reach wider groups of patients exists through concomitant use in stroke treatment. Therefore, Lumosa will conduct series of multi-dose trials administering LT3001 alone or in combination with mechanical thrombectomy for further scientific exploration and validation. To verify its effectiveness and expand the patient population, Lumosa is also actively pursuing another Phase 2b multi-dose trials in the US where LT3001 is administered alone to AIS patients who are illegible to receive rt-PA or thrombectomy.

About Lumosa

Lumosa Therapeutics, Inc. is a clinical-stage pharmaceutical company dedicated to the development of novel therapies and solutions for neurological and oncological diseases with urgent unmet medical need. In addition to utilizing its own technology platform, the company is also actively engaged in scientific licensing and co-development collaboration -- building a pipeline from early to late-stage assets consisting of first-in-class and best-in-class drugs. Lumosa's mission is to enrich patients' quality of life through pioneering medical science, diverse collaborations, and a commitment to remain genuine and ever evolving. The company focuses on large and small molecule new drugs to address diseases related to central nervous system, inflammation and cancer. Current pipeline includes Naldebain®, an extended-release analgesic injection approved by Taiwan FDA, LT3001, a new drug for the treatment of acute ischemic stroke, LT5001, a topical ointment for uremic pruritus, and LT2003, a fusion protein for cancer currently at pre-clinical stage. Lumosa is publicly traded in Taipei Exchange (6535.TWO) 

Lumosa Spokesperson:
Judy Juang

(Image by Pete Linforth from Pixabay)