Korea-US 'Labscervey' New Drug Research Results Presented at European Association for the Study of Diabetes

[Asia Economy Reporter Lee Chun-hee] Hanmi Pharmaceutical announced on the 26th that it presented research results confirming the innovative potential of new drugs developed using its LAPScovery technology at the European Association for the Study of Diabetes (EASD). These include the triple-action bio-innovative new drug 'LAPS Triple Agonist (HM15211)' and the bio new drug for congenital hyperinsulinism treatment 'LAPS Glucagon Analog (HM15136)'.

The recent EASD was held from the 19th to the 23rd in Stockholm, Sweden. Hanmi Pharmaceutical announced on the 26th that it presented two research results on the LAPS Triple Agonist and one on the LAPS Glucagon Analog via online poster presentations.

Both drugs apply Hanmi Pharmaceutical's innovative platform technology 'LAPScovery (Long Acting Protein/Peptide Discovery)', which extends the half-life of protein therapeutics. This technology reduces the frequency and dosage of administration, thereby minimizing side effects while improving efficacy.

Hanmi Pharmaceutical's platform technology 'LabscerV'

The LAPS Triple Agonist, under development as a treatment for non-alcoholic steatohepatitis (NASH), is a 'triple-action' bio-innovative drug that activates the glucagon-like peptide-1 (GLP-1) receptor, glucagon receptor, and glucose-dependent insulinotropic polypeptide (GIP) receptor. Based on its multi-pharmacological effects, it is expected to effectively improve complex symptoms such as fatty liver, liver inflammation, and liver fibrosis in NASH patients.

At this conference, Hanmi Pharmaceutical presented research results confirming the excellent anti-inflammatory and anti-fibrotic effects of the LAPS Triple Agonist in a liver fibrosis-induced model (TAA mice). They also reported significant therapeutic efficacy in most existing liver inflammation and fibrosis models, demonstrating its potential as an innovative treatment for NASH.

Additionally, Hanmi Pharmaceutical presented research showing that the LAPS Triple Agonist dramatically improves lung function and survival rates in an idiopathic pulmonary fibrosis (IPF) model. This suggests that the LAPS Triple Agonist could expand its therapeutic scope to pulmonary fibrosis, a condition with significant unmet medical needs.

The U.S. Food and Drug Administration (FDA) designated the LAPS Triple Agonist as a fast-track development drug in 2020. Hanmi Pharmaceutical is currently conducting Phase 2b clinical trials in the U.S. and Korea targeting NASH and liver fibrosis patients confirmed by biopsy.

Exterior view of Hanmi Pharmaceutical headquarters

Hanmi Pharmaceutical also presented research results on the LAPS Glucagon Analog, the world's first once-weekly injectable bio new drug under development for congenital hyperinsulinism treatment. The presentation included findings that the LAPS Glucagon Analog effectively improved body weight, fatty liver, and blood cholesterol levels in obesity-induced models, and reduced urinary albumin excretion and albumin-to-creatinine ratio (ACR) in chronic kidney disease animal models. Hanmi Pharmaceutical explained that these results confirm glucagon receptor activation as a potential therapeutic target for metabolic kidney diseases.

The LAPS Glucagon Analog was recognized for its innovation in monotherapy by being featured as the cover article in the March issue of the SCI international journal 'Diabetes, Obesity and Metabolism (DOM)'. In 2018, the FDA and European Medicines Agency (EMA) designated the LAPS Glucagon Analog as an orphan drug for congenital hyperinsulinism. Subsequently, in 2020, the EMA designated it as an orphan drug for insulin autoimmune syndrome, and the FDA additionally designated it as a rare pediatric disease (RPD) drug.

Kwon Se-chang, CEO of Hanmi Pharmaceutical, stated, “Following the FDA approval of 'Rolontis' (U.S. product name Rolbedon), expectations for our platform technology ‘LAPScovery’ applied to our bio new drugs have grown even higher. Based on the preclinical and current clinical studies of the LAPS Triple Agonist and LAPS Glucagon Analog, we will do our utmost to develop them into innovative treatments as soon as possible.”

This content was produced with the assistance of AI translation services.