[헬스코리아뉴스 / 이순호] Two innovative new drugs for rare disease treatment, which Hanmi Pharm is developing, will begin global phase 2 clinical trials.
Hanmi Pharmaceutical recently received approval for Phase 2 clinical trials for innovative new drugs for rare disease treatment’LAPSGlucagon Analog’ (HM15136) and’LAPSGLP-2 Analog’ (HM15912) from the US FDA.
‘LAPSGlucagon Analog’, which is being developed as an innovative new drug for the treatment of congenital hyperinsulinemia, is the world’s first once-a-weekly long-acting glucagon derivative that applies Hanmi Pharmaceutical’s Labscovery platform technology to increase the efficacy of biopharmaceuticals.
Patients suffering from congenital hyperinsulinemia, a rare disease that affects about 1 in 25,000 to 50,000 people, do not have a treatment approved for the disease so far, so they can take side effects and use off-label drugs or surgery Depends on enemy surgery.
For this reason, the US FDA and European EMA designated’LAPSGlucagon Analog’ as an orphan drug for congenital hyperinsulinemia in 2018. Last year, EMA and FDA additionally designated’LAPSGlucagon Analog’ as an orphan drug for insulin autoimmune syndrome and a rare drug for children (RPD), respectively.
An official of Hanmi Pharm said, “‘LAPSGlucagon Analog’ shows superior effect in solubility and stability compared to existing glucagon drugs, and in a hyperinsulinemia model showing severe hypoglycemia, we have confirmed the effect of maintaining normal blood sugar continuously after administration.” “We expect to be able to demonstrate innovative results in this phase 2 clinical trial involving pediatric patients.”
‘LAPSGLP-2 Analog’ (HM15912) is being developed as an innovative new drug for treating short bowel syndrome with the maximum once-monthly dosage form by applying Labscovery platform technology.
Short bowel syndrome is a rare disease that causes sudden malnutrition due to malabsorption due to the loss of more than 60% of the entire small intestine through congenital or postnatal surgical resection. It occurs in 5 or less per 100,000 (24 per 100,000 newborns), and patients are artificially supplemented with nutrients using the total venous nutrition method (a method of supplying nutrients through the vena cava or peripheral blood vessels without going through the gastrointestinal tract) to maintain growth and life. Depends on
The total vein nutrition method takes more than 10 hours a day, making normal daily life difficult. In the long term, it may cause fatal side effects such as liver failure, thrombosis, infection, and sepsis.
Hanmi Pharm believes that’LAPSGLP-2 Analog’ maximizes the excellent chorioblast growth promotion effect to increase the efficiency of absorption of nutrients in patients, and it is the longest once-monthly dosage form that can significantly improve the quality of life of patients with short bowel syndrome. I’m looking forward to it.
The US FDA and European EMA designated’LAPSGLP-2 Analog’ as an orphan drug for treatment of short bowel syndrome in 2019, and the FDA additionally designated’LAPSGLP-2 Analog’ as a pediatric rare drug (RPD) last year.
An official from Hanmi Pharm said, “As’LAPSGlucagon Analog’ and’LAPSGLP-2 Analog’ obtained FDA approval for Phase 2 clinical trials, we plan to sequentially proceed with phase 2 clinical trials in multiple countries including many European countries.” “We plan to continue to secure evidence of clinical treatment effects for patients with rare diseases by analyzing them.”
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