June 26, 2024 — Laekna, Inc. (2105.HK) announced that the first subject has been dosed in the phase I clinical trial of internally discovered LAE102 (a monoclonal antibody against ActRIIA) at Zhongshan Hospital affiliated to Fudan University, Shanghai, China.

LAE102 is a monoclonal antibody against 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 mass and decrease fat mass. Investigational New Drug (IND) approvals have been obtained from the U.S. Food and Drugs Administration (FDA) and the Centre for Drug Evaluation of the National Medical Products Administration of China (CDE) in relation to obesity indication for LAE102 in the first half of 2024. The phase I clinical trial is a randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability and pharmacokinetics of LAE102 injection in heathy adults and overweight/obesity patients.

Globally, the number of people living with obesity is set to reach over 1.2 billion by 2030.¹ “Obesity is a complex chronic disease which has become an important health problem in China with severe health impairments to people. Novel clinical approaches and innovative drugs have been emerging recently targeting weight loss. New medicines with the potential of more favorable efficacy and better safety file are in development", said Professor Linong Ji of Peking University People’s Hospital, Chairman of the Expert Advisory Committee of Laekna Overweight / Obesity Clinical Projects, “Obesity patients and physicians are setting higher expectations and requirements on quality, safety and persistency of weight loss. It is targeted to reduce fat and to preserve muscle, as well as to achieve a persistent weight loss result. I hope this innovative therapy can benefit more patients with obesity”.

ActRII is an activin receptor expressed both in adipose and muscle cells. Activation of this signaling pathway leads to fat accumulation and muscle atrophy. Professor Xuening Li of Zhongshan Hospital affiliated to Fudan University,  principal investigator of the phase I clinical trial, said that inhibitors targeting Activin-ActRII pathway are expected to increase lean mass and decrease fat mass. The first-in-human study will focus on evaluating the safety and tolerability of this novel therapy.

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¹Source: World Obesity Federation, 2023b

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About LAE102

LAE102 is Laekna’s internally discovered monoclonal antibody against 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 mass and decrease fat mass. In combination with GLP1R agonist, LAE102 can further reduce fat mass and dramatically attenuates lean mass loss induced by GLP1R agonist. This makes LAE102 a drug candidate for achieving quality weight control through reducing fat while keeping muscle mass.

Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass. Laekna team is developing more drug candidates to maximize the value of targeting ActRII receptors. LAE103 is an ActRIIB-selective antibody and LAE123 is a dual inhibitor for ActRIIA/IIB. Both are the company’s internally discovered antibodies for muscle regeneration and other disease indications in the drug candidate pipeline.

About Laekna

Stock Code: 2105.HK

Founded in 2016, Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapies to cancer, metabolic diseases and liver fibrosis patients worldwide.

As of December 31, 2023, we have initiated six clinical trials for afuresertib (LAE002), LAE001 and LAE005 for the treatment of breast cancer, prostate cancer, ovarian cancer and PD-1/ PD-L1 drug-resistant solid tumors to address the unmet medical needs. Among these six clinical trials, three are multi-regional clinical trials (MRCTs). Afuresertib is a potent AKT inhibitor that inhibits all three AKT isoforms (AKT1, AKT2 and AKT3) as well as one of the only two AKT inhibitors in or completed the pivotal-stage clinical development for anti-cancer treatment globally.

Laekna’s internal drug discovery platform has discovered 14 drug candidates. LAE102 is our internally discovered antibody against ActRIIA. We’ve obtained IND approvals from the FDA and the CDE in relation to obesity. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass. Laekna team has accumulated tremendous experience and deep know-how in this specific field and is developing more drug candidates (LAE103 and LAE123) to maximize the value of targeting ActRII receptors. 

Laekna, Inc. was listed on the Main Board of The Stock Exchange of Hong Kong Limited (the “Hong Kong Stock Exchange”) on June 29, 2023, with the stock code 2105.HK. 

For more information, please visit: https://www.laekna.com/  or https://www.linkedin.com/company/74110713/

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