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Statement
| 1.Date of occurrence of the event:2022/02/25
2.Company name:Lumosa Therapeutics Co., Ltd.
3.Relationship to the Company (please enter "head office" or
"subsidiaries"):head office
4.Reciprocal shareholding ratios:Not applicable
5.Cause of occurrence:
Lumosa receives the results of LT1001 Phase 3 trial conducted by Chinese
partner, Jemincare.
6.Countermeasures:Not required
7.Any other matters that need to be specified:
(1)New drug name or code: LT1001, Naldebain
(2)Indication: Relief of moderate to severe acute postoperative pain,
administered pre-surgically.
(3)Planned development stages: Not applicable
(4)Current development stage:
A.Submitted/approved/disapproved:
The analysis results of the Phase 3 trial that was conducted in China
by Lumosa's partner, Jemincare.
(A) Study Results
a.Study title:
A multi-center, randomized, double-blind, placebo parallel-controlled
study to assess the efficacy and safety of Naldebain, a long-acting
analgesic injection to relieve postoperative pain.
b.Number of subjects in the trial: 120 (number of subjects actually
enrolled: 124)
c.Primary objective:
The results showed that the morphine equivalent dosage used within 48
hours after surgery in the LT1001 group was 21.76, while that for the
placebo group was 18.36; no statistically significant difference was
observed (p=0.86).
d.Secondary objective:
1.Area under the curve of the visual analog scale (VAS) of pain
intensity within 48 hours after the surgery for the LT1001 group was
1164.56, while that for the placebo group was 1124.25; no
statistically significant difference was observed (p=0.76).
2.Safety endpoint: A total of 11 severe adverse events occurred in a
total of 10 subjects (4 subjects in the LT1001 group and 6 subjects
in the placebo group); none were related to the study drug. A total
of 32 subjects (21 subjects in the LT1001 group, 11 subjects in the
placebo group) experienced at least one adverse effects, the severity
was mild in nature.
(B)The results from a single trial are not sufficient to fully reflect
the success or the failure of new drug development. Investors are
advised to exercise caution and conduct a thorough evaluation before
investing.
B.The risks and the measures taken by the company if fail to obtain the
approval from the said competent authorities: Not applicable.
C.Future strategies after obtaining official approval: Not applicable.
D.Accumulated investment expenditure incurred: The information is not
disclosed at this time to avoid impacts to future international
licensing negotiation, and to protect the equity of the shareholders.
(5)Upcoming development plan:
A.Scheduled completion date: Not applicable.
B.Estimate responsibilities: Not applicable.
(6)Explanations:
A.LT1001 is developed as an extended-release formulation of the prodrug
of nalbuphine, an analgesic agent available in the market for many
decades. LT1001 received market approval from Taiwan FDA in March of
2017 (brand name in Taiwan: NaldebainR) and has accumulated years of
clinical data. The drug received market approval from Singapore and
Thailand.
B.Lumosa licensed the development and commercialization rights of LT1001
in China to Jemincare in December 2019. Jemincare is responsible to
conduct necessary trials prior to market approval in China. As the
results of the Phase 3 trial did not reach a statistically significant
difference, Jemincare aims to conduct further analysis on the cause,
re-design the trial, and continue the clinical development in China.
(7)New drug development takes considerable investment in time and money
and the success of the development is not guaranteed. Investors should
be aware of the associated risks involved and proceed with investment
after making thorough evaluations.
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