Hanmi Pharmaceutical recently presented LAPSGlucagon Analog (HM15136) and LAPSGLP-2 Analog (HM15912), an innovative new drug for treatment of rare diseases at the JP Morgan conference. In response, as the US FDA approves phase 2 clinical trials, Hanmi Pharmaceutical announced on the 21st that it will begin global phase 2 clinical trials of these two new drugs.
“The development of innovative new drugs in the field of rare diseases is one way to practice the human respect and value creation, which are Hanmi’s management philosophy,” said Hanmi Pharm President Kwon Se-chang. “The development of treatments for rare diseases will be an important milestone in determining the future value of Korea and the United States. I said.
LAPSGlucagon Analog, which is being developed as an innovative new drug for the treatment of congenital hyperinsulinemia, is a long-acting glucagon derivative made into a once-a-week dosage form for the first time in the world by applying Hanmi Pharmaceutical’s’Labs Coverage’ platform technology that increases the efficacy of biopharmaceuticals.
Patients suffering from congenital hyperinsulinemia, a rare disease that affects 1 out of 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 surgical procedures. Depend on.
Accordingly, the US FDA and European EMA designated LAPSGlucagon Analog as an orphan drug for congenital hyperinsulinemia in 2018. In 2020, EMA was additionally designated as an orphan drug for insulin autoimmune syndrome, and the FDA designated it as a pediatric rare drug (RPD).
Hanmi Pharm confirmed that LAPSGlucagon Analog exhibits superior solubility and superior stability compared to existing glucagon drugs, as well as the effect of maintaining normal blood sugar after administration in a severe hypoglycemic hyperinsulinemia model. Hanmi Pharm is expecting 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. 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 life difficult, and in the long term, it causes fatal side effects such as liver failure, thrombosis, infection, and sepsis.
Hanmi Pharm expects that LAPSGLP-2 Analog is the longest dosage form once a month, and can enhance the efficiency of patient absorption of nutrients by maximizing the excellent chorionic cell growth promoting effect, thereby improving the quality of life of patients.
The US FDA and European EMA designated 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 LAPSGlucagon Analog and LAPSGLP-2 Analog obtained FDA approval for Phase 2 clinical trials, Hanmi Pharmaceutical plans to sequentially carry out phase 2 clinical trials in multiple countries including several European countries. By analyzing safety and efficacy, it is expected to continuously secure evidence of clinical treatment effects for patients with rare diseases.
Reporter Se-ra Kim, Consumer Economic Daily