ADA 2025 | Laekna Presented Clinical and Pre-clinical Studies Results of LAE102, LAE103 and LAE123

LOS ANGELES--(BUSINESS WIRE)--Jun 23, 2025--

Laekna (2105.HK) announced today that the results of: i) the phase I SAD study of LAE102 (an ActRIIA-selective antibody) for the treatment of obesity; and ii) the pre-clinical study of LAE102, LAE103 (an ActRIIB-selective antibody) and LAE123 (an ActRIIA/IIB dual antagonistic monoclonal antibody) as therapeutics for muscle growth and fat reduction were presented at the 85 th scientific sessions of the American Diabetes Association (ADA).

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250623952873/en/

ADA is one of the global leading conferences dedicated to diabetes research, care, and innovation and has taken place in Chicago, USA, from June 20 to 23 this year.

Professor Xuening LI, Zhongshan Hospital affiliated to Fudan University,Principal Investigator of the Phase I Clinical Trial of LAE102 in China

“The clinical research team at Zhongshan Hospital affiliated to Fudan University conducted the first-in-human study of LAE102 in a scientific, efficient, and rigorous manner. As the Principal Investigator of this trial, I am delighted to see this First-in-class research achievement being presented at the scientific sessions of the 2025 ADA. Based on the clinical data of LAE102 in overweight and obese populations, we endorse further clinical development of this innovative drug candidate.”

Professor Linong JI, Peking University People’s Hospital, Chairman of the Expert Advisory Committee of Laekna Overweight / Obesity Clinical Projects

“We continued to witness cutting-edge researches in metabolism and weight management leading the industry, with “China Innovation” demonstrating great potential and impact. Even more exciting is the emergence of novel pathways and targets like ActRII, which can be the next generation of high-quality weight-loss therapies following GLP-1. We congratulate the team on the positive data from the first-in-human study of LAE102 and look forward to more comprehensive and diverse data from its global study in the next phase, which may address current clinical challenges – including concurrent muscle loss during fat reduction – seen with existing therapies.”

Dr. Chris LU, Chairman and CEO of Laekna

“At the ADA Scientific Sessions, Laekna showcased LAE102, LAE103, and LAE123 – an innovative portfolio targeting the ActRII pathway – highlighting our team's extensive expertise and leadership in this field. We extend our deepest gratitude to the investigators, advisory experts, trial participants, and global clinical partners for their invaluable contributions.

As a pioneer in research and development of ActRII pathway, we are committed to collaborating with global partners to conduct extensive and in-depth investigations of this target. Through developing novel drug candidates and expanding therapeutic indications, we aim to fully unlock its potential to benefit patients with obesity, sarcopenia, and other severe diseases.”

Presentation details are as follows:

Poster No.1
Abstract Number: 2205-LB
Title: First-in-Human Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LAE102 in Healthy Volunteers

Highlights:

Poster No.2
Abstract Number: 861-P
Title: Targeting Activin Type II Receptors—Develop Monoclonal Antibodies LAE102, LAE103, and LAE123 as Candidate Therapeutics for Muscle Growth and Fat Reduction

Highlights:

Laekna has established a comprehensive portfolio of targeting ActRII receptors and is progressing the clinical trials of LAE102 for the treatment of obesity in China and the US. Additionally, LAE103 and LAE123 have advanced to IND-enabling studies. Laekna is actively advancing these drug candidates to clinical studies as novel therapies for muscle and other disease indications.

About Laekna

Stock Code: 2105.HK

Founded in 2016, Laekna is a science-driven, clinical-stage biotechnology company committed to bringing novel therapeutics to patients with metabolic diseases, cancer and liver fibrosis around the world.

As of December 31, 2024, Laekna has initiated seven clinical trials for LAE102, LAE002 (afuresertib), LAE001 and LAE005 to address unmet medical needs in obesity and cancers.

LAE102 is our internally discovered antibody against ActRIIA. Blocking Activin-ActRII pathway could promote muscle regeneration and decrease fat mass, this positions LAE102 as a promising drug candidate for achieving quality weight control. We’ve obtained IND approvals from the FDA and the CDE for LAE102 in obesity indication and are advancing the Phase I clinical trial in China. In November 2024, Laekna entered into a clinical collaboration agreement with Eli Lilly and Company to support and accelerate global clinical development of LAE102 for the treatment of obesity.

Laekna team has accumulated tremendous experiences and deep know-how in the specific field of targeting ActRII receptors and is developing more drug candidates (LAE103 and LAE123), in addition to LAE102, to maximize the value of the target. LAE103 is an ActRIIB-selective antibody and LAE123 is a dual inhibitor against ActRIIA/IIB. Both are our internally discovered antibodies for muscle and other disease indications.

In the cancer area, Laekna has built a comprehensive portfolio of drug candidates including LAE002(afuresertib), LAE001 and other seven pre-clinical drug candidates. LAE002 (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 late-stage development for breast and prostate cancer globally. Laekna has commenced the Phase III clinical trial (AFFIRM-205) for LAE002 in patients with HR+/HER2- breast cancer and the study recruitment is on track.

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

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

Forward-Looking Statements

This press release may contain certain “forward-looking statements” which are not historical facts, but instead are predictions about future events based on Laekna’s current beliefs, assumptions and expectations, commonly identified by words such as "would", "may", "expects", "believes", "plans", "intends", "projects" and other terms with similar meaning. Although we believe that our predictions are reasonable, future events are inherently uncertain and our actual future results or performance may be materially different from what we expect. Accordingly, you are strongly cautioned that reliance on any forward-looking statements is subject to significant known and unknown risks and uncertainties. All forward-looking statements contained herein are qualified by reference to the cautionary statements set forth in this section. All information provided in this press release is as of the date of this press release and are based on assumptions that we believe to be reasonable as of this date, and we do not undertake any obligation to update any forward-looking statement, except as required under applicable law.

Laekna (2105.HK), a science-driven, clinical-stage biotechnology company, announced that the results of: i) the phase I SAD study of LAE102 (an ActRIIA-selective antibody) for the treatment of obesity; and ii) the pre-clinical study of LAE102, LAE103 (an ActRIIB-selective antibody) and LAE123 (an ActRIIA/IIB dual antagonistic monoclonal antibody) as therapeutics for muscle growth and fat reduction were presented at the 85th scientific sessions of the American Diabetes Association (ADA).

ALEPPO, Syria (AP) — First responders on Sunday entered a contested neighborhood in Syria’ s northern city of Aleppo after days of deadly clashes between government forces and Kurdish-led forces. Syrian state media said the military was deployed in large numbers.

The clashes broke out Tuesday in the predominantly Kurdish neighborhoods of Sheikh Maqsoud, Achrafieh and Bani Zaid after the government and the Syrian Democratic Forces, the main Kurdish-led force in the country, failed to make progress on how to merge the SDF into the national army. Security forces captured Achrafieh and Bani Zaid.

The fighting between the two sides was the most intense since the fall of then-President Bashar Assad to insurgents in December 2024. At least 23 people were killed in five days of clashes and more than 140,000 were displaced amid shelling and drone strikes.

The U.S.-backed SDF, which have played a key role in combating the Islamic State group in large swaths of eastern Syria, are the largest force yet to be absorbed into Syria's national army. Some of the factions that make up the army, however, were previously Turkish-backed insurgent groups that have a long history of clashing with Kurdish forces.

The Kurdish fighters have now evacuated from the Sheikh Maqsoud neighborhood to northeastern Syria, which is under the control of the SDF. However, they said in a statement they will continue to fight now that the wounded and civilians have been evacuated, in what they called a “partial ceasefire.”

The neighborhood appeared calm Sunday. The United Nations said it was trying to dispatch more convoys to the neighborhoods with food, fuel, blankets and other urgent supplies.

Government security forces brought journalists to tour the devastated area, showing them the damaged Khalid al-Fajer Hospital and a military position belonging to the SDF’s security forces that government forces had targeted.

The SDF statement accused the government of targeting the hospital “dozens of times” before patients were evacuated. Damascus accused the Kurdish-led group of using the hospital and other civilian facilities as military positions.

On one street, Syrian Red Crescent first responders spoke to a resident surrounded by charred cars and badly damaged residential buildings.

Some residents told The Associated Press that SDF forces did not allow their cars through checkpoints to leave.

“We lived a night of horror. I still cannot believe that I am right here standing on my own two feet,” said Ahmad Shaikho. “So far the situation has been calm. There hasn’t been any gunfire.”

Syrian Civil Defense first responders have been disarming improvised mines that they say were left by the Kurdish forces as booby traps.

Residents who fled are not being allowed back into the neighborhood until all the mines are cleared. Some were reminded of the displacement during Syria’s long civil war.

“I want to go back to my home, I beg you,” said Hoda Alnasiri.

Associated Press journalist Kareem Chehayeb in Beirut contributed to this report.

Sandbag barriers used as fighting positions by Kurdish fighters, left inside a destroyed mosque in the Sheikh Maqsoud neighborhood, where clashes between government forces and Kurdish fighters have been taking place in the northern city of Aleppo, Syria, Sunday, Jan. 11, 2026. (AP Photo/Ghaith Alsayed)

Burned vehicles at one of the Kurdish fighters positions at the Sheikh Maqsoud neighborhood, where clashes between government forces and Kurdish fighters have been taking place in the northern city of Aleppo, Syria, Sunday, Jan. 11, 2026. (AP Photo/Ghaith Alsayed)

People flee the Sheikh Maqsoud neighborhood, where clashes between government forces and Kurdish fighters have been taking place in the northern city of Aleppo, Syria, Sunday, Jan. 11, 2026. (AP Photo/Ghaith Alsayed)

A Syrian military police convoy enters the Sheikh Maqsoud neighborhood, where clashes between government forces and Kurdish fighters have been taking place in the northern city of Aleppo, Syria, Sunday, Jan. 11, 2026. (AP Photo/Ghaith Alsayed)

Burned vehicles and ammunitions left at one of the Kurdish fighters positions at the Sheikh Maqsoud neighborhood, where clashes between government forces and Kurdish fighters have been taking place in the northern city of Aleppo, Syria, Sunday, Jan. 11, 2026. (AP Photo/Ghaith Alsayed)