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Lumosa Receives U.S. FDA Fast Track Designation for Its LT3001, a Novel Drug for the Treatment of Acute Ischemic Stroke

(Taipei, Taiwan; January 11th, 2022) Lumosa Therapeutics Co., Ltd. (Lumosa; code: 6535.TWO), a new drug research and development company, announced today that the US Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for its LT3001, a new drug for the treatment of acute ischemic stroke. The designation allows LT3001 to receive additional assistance such as intensive consultation and rolling reviews to facilitate clinical development and drug approval process as well as an opportunity for priority review. 

Lumosa's CEO, Mr. Rongjin Lin stated that "brain stroke has extremely high fatality and disability rates. There are few treatment options with limited effect for current therapy. For more than two decades, no new drugs for the treatment of acute ischemic stroke have been successfully developed, presenting a clear and urgent medical need in the world. FDA encourages biotech companies to develop drugs that treat serious diseases or satisfy unmet medical needs with its Fast Track Designation. This designation not only highlights LT3001's therapeutic potential, decreases development risks, but also facilitates the drug registration process. We look forward to seeing more patients and families benefit from LT3001 as soon as possible."

LT3001 is an innovative drug developed for the treatment of acute ischemic stroke. Lumosa received positive results from the multi-center, randomized double-blind, single-dose, placebo-controlled Phase 2a clinical trial conducted on stroke patients who had stroke onset of fewer than 24 hours in Taiwan and the United States in August 2021. LT3001 was shown to be safe without increased risks of symptomatic intracranial hemorrhage while exhibiting improvements in neurological behaviors and functions.

In terms of the US market, the FDA has cleared the Phase 2 clinical trial in September 2021 where LT3001 is used in combination with mechanical thrombectomy in multiple doses. In addition, Lumosa is also actively preparing for the multi-dose Phase 2b trial of LT3001 without the co-administration of mechanical thrombectomy in Taiwan and the United States. The Fast Track Designation approved by the US FDA allowed Lumosa to develop LT3001 more efficiently.

About Lumosa
Lumosa Therapeutics, a public traded company in Taipei Exchange (6535.TWO), is dedicated to the development of innovative new drugs for the treatment of neurological and inflammatory diseases of unmet medical needs. The company is actively engaged in scientific in-licensing and new drug development under the “reSEARCH and DEVELOPMENT” model. This model is executed by a highly capable and experienced cross-functional teams of translational research, CMC, preclinical, clinical development, project management, regulatory affairs, intellectual property and business development experts. Current products/pipeline include Naldebain®, a long long-acting analgesic injection, launched in Taiwan in 2017, Singapore in 2021, and Thailand in 2022; LT3001, an NCE for the treatment of acute ischemic stroke currently under phase II clinical trial in the US and Taiwan; LT2003, tumor-targeting enzyme prodrug; and LT5001, a novel topical drug for uremic pruritus. Visit www.lumosa.com.tw for more information.

Media Contact: Jocelyn Lin (spokesperson@lumosa.com.tw)

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