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Posted date

2016.11.23

Global Marketing of Minimally Invasive Surgery Devices by LAGIS

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Lumosa Therapeutics is dedicated to the development of innovative new drugs for the treatment of unmet medical needs in the fields of CNS, oncology, and inflammatory diseases. The company is actively engaged in scientific licensing and new drug development under a “reSEARCH and DEVELOPMENT” model. We select drug candidates with strong scientific rationale and high feasibility of technical success, and progress them to differentiated products via inventive and effective development programs. This model is executed by a very capable multi-functional team that covers translational research, CMC, preclinical, clinical development, project management, regulatory affairs, intellectual property and business development. We integrated project management with subject matter experts to efficiently identify, select and develop novel drug products with global market potential, and seek international partners for collaboration in clinical trial, product development, and commercialization. The two front runners in our pipeline are LT1001 for moderate to severe pain relief and LT3001 for acute ischemic stroke.

LT1001 is the first long-acting analgesic injection containing sebacoyl dinalbuphine, a prodrug of nalbuphine formulated in oil-based formulation intended for sustained release of the drug. Nalbuphine is a κ-agonist / partialμ-antagonist analgesic with analgesic effect comparable to morphine, while it exerts a ceiling effect on respiratory depression. LT1001 was designed to take advantages of nalbuphine’s safety profile, and to overcome the disadvantage of nalbuphine’s relatively short half-life. While most pain medications relieve pain for only 2-6 hours, LT1001 exerts its analgesic effect for up to a week. In a post-operative setting, LT1001 will greatly increase pain patients’ quality of life and reduce healthcare burden, thus deliver a greater pharmacoeconomic value. LT1001 completed a phase III study in Taiwan and was successfully out-licensed in Taiwan with target product launch in 2017 in Taiwan. A NDA is currently under review by the TFDA.

LT3001 contains a new chemical entity which is composed of a thrombolytic polypeptide and a small molecule moiety with anti-oxidation (neuroprotection) activity. In multiple rodent disease models, where LT3001 was administered beyond the “golden (3) hours” post- stroke when the use of tPA is restricted, LT3001 significantly reduced brain infarction, restored blood flow and improved neuronal behavior score without hemorrhage. LT3001 holds promise as a safer and efficacious therapy for the treatment of acute ischemic stroke. IND applications in the US and Taiwan are planned this year.

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