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Lumosa’s Lead Candidate LT3001 for Acute Ischemic Stroke Approaching Key Milestone, Targeting Unblinding in Late 2024

(Taipei, Taiwan, December 5, 2023) Lumosa Therapeutics Co., Ltd. (Lumosa, TWO.6535) held its investors’ conference today (Dec. 5th). The Company is fully dedicated to the development of its new drug, LT3001, for the treatment of acute ischemic stroke. Several multi-national, multi-center, Phase 2 trials have been initiated in Taiwan, the US, Europe and China. The trials are progressing on schedule with the goal of unblinding pivotal data by late 2024 to support global licensing activities. According to Lumosa Chairman Mr. Rong-Jin Lin, there remains a tremendous unmet need in the treatment for acute ischemic stroke. With patient recruitment ahead of projections, LT3001 is rapidly approaching key milestones. The Company anticipates that LT3001 will revolutionize stroke therapy and overcome current treatment barriers.

Progress of Lumosa’s Key Projects

LT3001 is a first-in-class new chemical entity designed with dual potential of thrombolysis and neuroprotection for the treatment of acute ischemic stroke. There are currently three ongoing pivotal Phase 2 clinical trials evaluating LT3001 as both a monotherapy and as an adjunct to mechanical thrombectomy. Lumosa is leading two of the three multinational trials and is actively conducting patient recruitment in Europe to accelerate the trial progress. In addition, the enrollment progress for one of the trials conducted by Lumosa’s partner, Shanghai Pharmaceuticals, in China, has surpassed the expectations with over half of the target patients enrolled within its first year of initiation.

Furthermore, the formulation patent for LT3001 was granted by USPTO this year, extending the patent protection to 2040. Furthermore, there is a possibility to extend the patent until 2042 through protecting dosing regimen. The reviewing process for drug approval can be accelerated further with the “Fast Track Designation” status previously granted by the US FDA. With a comprehensive product strategy in place, Lumosa combines diverse clinical trial design schemes to continuously explore the maximum value of our pipeline.

On the other hand, Lumosa’s LT1001, an extended-release analgesic injection, has received approvals from Ukraine and Brunei this year. The drug has already received market approval from four countries: Taiwan, Singapore, Thailand and Malaysia. In addition, the pivotal study for the animal-use version is underway, taking steps to expand into the international market. Moreover, Lumosa is actively building a new drug incubation platform, and is continuously exploring the possibilities of novel technologies such as exosomes, allogeneic cell therapy, and gene therapy. The Company aims to allocate resources and use its established network and influence to develop the next blockbuster drug, following in the successful path of LT3001.

About Lumosa Therapeutics
Lumosa Therapeutics Co., Ltd. (Lumosa) is a drug development company that focuses on scientific licensing and co-development collaboration to build sustainable pipelines under its “reSEARCH and DEVELOPMENT” model. Lumosa selects novel drug candidates with strong scientific rationale and high feasibility of technical success for further development before out-licensing. The company’s focus is on Large- and small-molecule treatment for CNS and oncology.
Lumosa’s pipeline includes the extended-release analgesic injection Naldebain® (approved in Taiwan, Singapore, Thailand, Malaysia, Ukraine and Brunei), LT3001, a new chemical entity for the treatment of acute ischemic stroke currently under Phase 2 trial, and exosomes. Please visit the Lumosa website for details.