TAIPEI, Taiwan, Aug. 1, 2017 /PRNewswire/ -- Lumosa Therapeutics Co., Ltd., (TPEx: 6535, hereinafter 'Lumosa') is pleased to announce the enrollment of the first subject for the Phase 1 clinical trial of its new drug candidate, LT3001, for acute ischemic stroke. The first human subject was dosed with LT3001 in California, USA on July 28, 2017. The trial is expected to be completed in the first quarter of 2018.
LT3001 is a novel small molecule drug for the treatment of acute ischemic stroke. In animal studies, LT3001 can restore blood flow, reduce cerebral infarct volume, and improve neurological outcome in rodent and non-human primate stroke models, in which LT3001 showed an apparent wider therapeutic time window and a better safety profile than those reported for recombinant tissue plasminogen activator (rtPA). Up to 80 healthy volunteers will be enrolled in this double-blind, placebo controlled phase 1 single ascending dose study to evaluate the safety and pharmacokinetics of LT3001, results from the phase 1 study will determine the doses for subsequent clinical studies in stroke patients.
Stroke remains one of the world's major unmet medical needs, with no breakthrough new drugs approved in the past 20 years. Stroke afflicts over 15 million people worldwide each year, of which 87% of cases are ischemic stroke, which occurs as a result of a clot in the vessels supplying blood to the brain. Due to limitation, contraindications, and concerns over its known side effects, currently only around 3-5% of acute ischemic stroke patients receive the first line rtPA treatment. Stroke not only endangers the lives of stroke patients but also imposes the families of the stricken with significant caretaking and financial burden.
Dr. Wendy Huang, CEO of Lumosa indicated "Lumosa and the international stroke communities are counting on LT3001, as it may provide better treatment to stroke patients. In order to come up with a feasible development plan, Lumosa is actively communicating with the stroke supporting groups and has incorporated their valuable advices into trial designs. The enrollment of the first human subject signifies a big step forward in the development of LT3001 for acute ischemic stroke patients. We hope this first clinical trial would confirm the safety of LT3001 in human, as it has already been demonstrated in the animal tests, and permit subsequent clinical trials of LT3001 in stroke patients."
*Lumosa was consecutively selected to present study results on LT3001 at the International Stroke Conference in 2014, 2016 and 2017. In 2015 Lumosa was invited to attend the Stroke Treatment Academic Industry Roundtable (STAIR) by its US hosts, the only attendee from the Asia Pacific region invited to attend this prestigious gathering of industry and research notables in the field of stroke research.
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 major products in Lumosa's pipeline are Naldebain®, a long long-acting analgesic injection, and LT3001, an NCE for the treatment of acute ischemic stroke. Naldebain® has received TFDA approval and launched in Taiwan in the Spring of 2017. LT3001 is under phase I clinical trial in the US.