Lumosa Therapeutics Announces US FDA Clearance of
IND Application for a Phase 2 Multi-Dose Study of LT3001
in Patients with Acute Ischemic Stroke.
Date of events
2022/02/09
To which item it meets
paragraph 10
Statement
1.Date of occurrence of the event:2022/02/09
2.New drug name or code:LT3001
3.Indication:Acute Ischemic Stroke
4.Planned development stages:
A.Phase 2, Phase 3, NDA
B.Lumosa will file Phase 2 CTA to TFDA
5.Current development stage:
(1) Application submission/approval/disapproval/each of clinical trials
(include interim analysis): Lumosa has received the acceptance of Phase
2 multi-dose clinical trial from the US FDA for LT3001 in patients with
acute ischemic stroke.
(2) Once disapproved by the 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. In order
not to affect the amount of licensing fee and to protect the equity of
the shareholders, the information related are not disclosed currently.
6.Upcoming development plan:
(1) Estimated date of completion: The Phase 2 multi-dose, multi-national,
multi-site study is expected to be completed within 2 years. The trial
will enroll 200 patients with acute ischemic stroke within 24 hours of
stroke symptom. The actual timeline depends on recruitment progress.
(2) Estimated responsibilities: None
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% of AIS patients are treated with
thrombolytics. Mechanical thrombectomy is another treatment option that
can be considered besides thrombolytic agent but it has limited clinical
efficacy. With its desirable safety profile, LT3001 may reach a market
size of US$10.6 billion if the drug can be applied either alone or in
combination with thrombectomy to stroke patients within the 24-hour
stroke onset.
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 09 February 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 09 February 2022 08:58:04 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. 
