• At week 5, the LAE102 6 mg/kg group exhibited a 1.7% increase in mean lean body mass and a 2.2% reduction in mean fat mass compared to the baseline
• Adjusted from the placebo control group, the mean lean body mass is increased by 4.6%, whereas the mean fat mass is reduced by 3.6%
• Consistent with the prior Phase I single ascending dose study of LAE102, the MAD Study demonstrated a well-tolerated safety profile, with no serious adverse events reported
• LAE102 reached steady state after 5 weekly subcutaneous injections and PK profile was consistent with its SAD Study. Robust PK/PD correlation further demonstrates the potential efficacy of LAE102 in overweight and obese population
VOLUNTARY ANNOUNCEMENT
This announcement is made by Laekna, Inc. (the ‘‘Company’’, together with its subsidiaries, the ‘‘Group’’) on a voluntary basis to inform the shareholders and potential investors of the Company about the latest business update of the Group.
The board (the ‘‘Board’’) of directors of the Company (the ‘‘Directors’’) is pleased to announce positive preliminary results from the Phase I multiple ascending dose study (the ‘‘MAD Study’’) of LAE102 for the treatment of obesity in China.
The MAD Study is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of LAE102, administered subcutaneously, in overweight/obese subjects.
Subjects and Doses
The MAD Study enrolled overweight/obese subjects with an average BMI of 29.4 kg/m2, including 3 subcutaneous ascending dose cohorts (2 mg/kg, 4 mg/kg and 6 mg/kg, given weekly for 4 weeks).
Preliminary Results: demonstrated an encouraging trend towards lean body mass increase and fat mass reduction
At week 5,
• The LAE102 6 mg/kg group exhibited a 1.7% increase in mean lean body mass
• And a 2.2% reduction in mean fat mass compared to the baseline
• Adjusted from the placebo control group, the mean lean body mass is increased by 4.6%, whereas the mean fat mass is reduced by 3.6%
A Well-tolerated Safety Profile
Consistent with the prior Phase I single ascending dose study (‘‘SAD Study’’) of LAE102, the MAD Study demonstrated a well-tolerated safety profile, with no serious adverse events reported. Majority of TEAEs were mild (grade 1) and transient lab test abnormality. There was no diarrhea, muscle spasm or acne reported. The safety results were consistent with the known safety profile and no new safety signals were observed.
Robust PK/PD
LAE102 reached steady state after 5 weekly subcutaneous injections and PK profile was consistent with its SAD Study. The robust PK/PD correlation further demonstrates the potential efficacy of LAE102 in overweight and obese population. The detailed study results will be presented at an upcoming scientific conference.
The positive results of the MAD Study support continuing clinical development of LAE102 for the treatment of obesity. Currently, the Group is in active discussions with multiple potential partners and intends to seek a partner who has shown serious commitments, backed by capital and willingness to prioritize this program, to accelerate clinical development and commercialization of LAE102. The Group maintains solid financial positions which allow us to be selective in evaluating potential partnership structures that align the interests of all parties to maximize the global potential of our assets.
About LAE102
LAE102 is an internally discovered monoclonal antibody selectively targeting ActRIIA, a receptor that plays an important role in muscle regeneration and lipid metabolism. In the pre-clinical models, LAE102 has been shown to increase lean body mass and decrease fat mass. In combination with GLP1R agonist, LAE102 can further reduce fat mass and significantly regain the lean body mass loss induced by GLP1R agonist. This positions LAE102 as a promising drug candidate for achieving quality weight control.
RISK WARNING
LAE102 MAY ULTIMATELY NOT BE SUCCESSFULLY DEVELOPED AND COMMERCIALIZED. THE COMPANY’S SHAREHOLDERS AND POTENTIAL INVESTORS ARE REMINDED TO EXERCISE CAUTION WHEN DEALING IN THE SECURITIES OF THE COMPANY.
By Order of the Board
Laekna, Inc.
Dr. LU Chris Xiangyang
Chairman
Hong Kong, September 29, 2025
As at the date of this announcement, the Board comprises Dr. LU Chris Xiangyang, Ms. XIE Ling and Dr. GU Xiang-Ju Justin as executive Directors; Dr. WANG David Guowei and Mr. SUN Yuan as non-executive Directors; and Dr. YIN Xudong, Dr. LI Min and Mr. ZHOU Jian as independent non-executive Directors.
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