Lumosa Therapeutics : Receives the Results of LT1001 Phase 3 Trial Conducted by Chinese Partner, Jemincare

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Provided by: LUMOSA THERAPEUTICS CO., LTD.
SEQ_NO	2	Date of announcement	2022/02/25	Time of announcement	19:57:31
Subject	Lumosa Receives the Results of LT1001 Phase 3 Trial Conducted by Chinese Partner, Jemincare
Date of events	2022/02/25	To which item it meets	paragraph 53
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.