LUMOSA Therapeutics announces TFDA's clearance
of Phase 2 IND application for multiple-dose of LT3001
in patients with acute ischemic stroke.
Date of events
2022/03/24
To which item it meets
paragraph 10
Statement
1.Date of occurrence of the event:2022/03/24
2.New drug name or code:LT3001
3.Indication:Acute Ischemic Stroke
4.Planned development stages:Phase 2, Phase 3, NDA
5.Current development stage:Phase 2- Prove of Concept
(1)Application submission/approval/disapproval/each of clinical trials(
include interim analysis): The Phase 2 clinical trial was cleared by the
US FDA and TFDA for LT3001 in patients with acute ischemic stroke
(2)Once disapproved by competent authority or each of clinical trials (
include interim analysis) results less than statistically significant
sense, the risks & the associated measures the Company may occur: NA
(3)After obtaining official approval or the results of statistically
significant sense, the future strategy: NA
(4)Accumulated investment expenditure incurred: The accumulated development
cost is related to future licensing negotiation. Relevant information is
not disclosed at this time to avoid unwanted impact on the licensing deal
and to protect the equity of the shareholders.
6.Upcoming development plan:
(1)Estimated date of completion: The Phase 2 study is expected to be
completed within 2 years. The actual timeline depends on recruitment
progress.
(2)Estimated responsibilities: NA
7.Market situation:
Brain stroke is one of several diseases that the medical community is
trying urgently to resolve. Each year, there are about 15 to 17 million
people in the world suffering stroke; among which, 80% of the patients are
ischemic. The current treatment for acute ischemic stroke (AIS) is a
thrombolytic agent named rt-PA. Unfortunately, the benefit of rt-PA is
limited due to its high risks involving hemorrhage and short treatment time
window, only 3%~5% AIS patients are treated with thrombolytics. Other than
thrombolytic agent, mechanical thrombectomy is another treatment options but
with limited clinical efficacy. Should LT3001 be presented with a desirable
safety profile, the drug can be applied either alone or in combination with
thrombectomy to the stroke patients within 24hr stroke onset, and the
potential market size could reach US$10.6 billion.
8.Any other matters that need to be specified:
According to the collaboration agreement between The Company and the
inventors of LT3001, the company will pay 5% of the license income if the
technology is licensed to a third part and 2% of the net sales revenue if
the product is marketed.
9.New drug development requires long process, vast investments and with
no guarantee in success which may pose investment risks.The investors
are advised to exercise caution and conduct thorough evaluation.:
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Lumosa Therapeutics Co. Ltd. published this content on 24 March 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 24 March 2022 10:41:06 UTC.
LUMOSA THERAPEUTICS CO., LTD. is a Taiwan-based company principally engaged in the development of new drugs. The Company is engaged in the development of new drugs for unmet medical needs in the fields of central nervous system (CNS), oncology, and inflammatory diseases. The Company is engaged in scientific licensing and new drug development under the reSEARCH and DEVELOPMENT model.
LUMOSA THERAPEUTICS CO., LTD. 
