/Photo = Hanmi Pharmaceutical
[포쓰저널=조혜승기자] Hanmi Pharm announced on the 21st that the US FDA has approved phase 2 clinical trials for LAPS Glucagon Analog and LAPSGLP-2 Analog, an innovative new drug for treating rare diseases, which were recently announced at the JP Morgan conference.
Accordingly, Hanmi Pharm will begin phase 2 global clinical trials of two new drugs.
The LAPS glucagon analog, which is being developed as an innovative new drug for the treatment of congenital hyperinsulinemia, is a long-acting glucagon derivative made in the world’s first once-a-week dosage form by applying Hanmi Pharmaceutical’s Lab Coverage platform technology to increase the efficacy of biopharmaceuticals.
Congenital hyperinsulinemia, a rare disease, affects 1 out of every 25,000 to 50,000 people, but there is no approved treatment so far, so they suffer side effects and use off-label drugs or rely on surgical operations. .
For this reason, the US FDA and European EMA designated the LAPS glucagon analog as an orphan drug for congenital hyperinsulinemia in 2018. In 2020, EMA is an orphan drug for insulin autoimmune syndrome, and the FDA has additionally designated it as a pediatric rare drug (RPD).
Hanmi Pharm has confirmed that the LAPS glucagon analog has excellent effects in solubility and stability compared to conventional glucagon drugs, and the effect of maintaining normal blood sugar continuously after administration in a hyperinsulinemia model showing severe hypoglycemia. The company expects to be able to demonstrate innovative results in this phase 2 clinical trial involving pediatric patients.
LAPSGLP-2 analog 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.
Short bowel syndrome occurs in 5 or less per 100,000 people (24 per 100,000 newborns), and patients are artificial 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. Rely on nutritional supplementation.
The total venous 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 expects that the LAPSGLP-2 analog maximizes the effect of promoting the growth of chorionic cells, which increases the efficiency of absorption of nutrients in patients, and is expected to significantly improve the quality of life of patients with short bowel syndrome as it is the longest monthly dosage form. .
The US FDA and European EMA designated the LAPSGLP-2 analog as an orphan drug for the treatment of short bowel syndrome in 2019, and the FDA designated it as a pediatric rare drug (RPD) in 2020.
As the LAPS glucagon analog and the LPASGLP-2 analog have obtained FDA approval for phase 2 clinical trials, Hanmi Pharmaceutical plans to sequentially conduct phase 2 clinical trials in multiple countries including many European countries.
“The development of innovative new drugs in the field of rare diseases is a way to practice respect for humanity and value creation, which is Hanmi’s management philosophy,” said Kwon Se-chang, president of Hanmi Pharmaceutical. “The development of treatments for rare diseases will be an important milestone in determining the future value of Hanmi.” said.
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