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Phase 2 IND for Lumosa's Novel Stroke Therapy Approved by Taiwan FDA

(Taipei, Taiwan, December 24th, 2021) Lumosa Therapeutics (Lumosa, 6535.TWO), announced today that the company received the approval of Phase 2 IND application for its LT3001, a first-in-class treatment for acute ischemic stroke (AIS), by the Taiwan FDA. Lumosa will initiate the trial in the US and Taiwan where multiple doses of LT3001 is being administered to AIS patients receiving mechanical thrombectomy.

There are 15 million people in the world who suffer a stroke each year according to the World Health Organization (WHO), and 85% of all stroke cases are ischemic stroke (due to lack of blood flow to critical areas of the brain). Although tissue plasminogen activator (tPA) and surgeries are available, 80% of stroke patients are still left with no other treatment options. Overcoming the safety restraints of current therapy to bring treatments to broader patient population has become a clear and urging medical needs. The potential market size of LT3001 could reach up to US$10.6 billion if the market gap is satisfied.

LT3001 is a novel drug for the treatment of AIS with thrombolytic and neuroprotective functions. Lumosa had completed a single-dose, randomized, and placebo-controlled prospective Phase 2a clinical study in August of 2021 in the US and Taiwan. Results showed that when administered to stroke patients within 24 hours of stroke onset, LT3001 demonstrated to be safe with no evidence of increased risks of symptomatic intracranial hemorrhage and showed potential in improving neurological behaviors and functions.