Hanmi Pharmaceutical announced on June 30 that LAPSGLP-2 Analog (code name: HM15912), which is being developed independently as a bio-medicine for treating short bowel syndrome, has been additionally designated as a Rare Pediatric Disease Designation (RPD) by the U.S. FDA.
This designation is the second of its kind following the LAPSGlucagon Analog, which was designated as the RPD on June 24.
Hanmi Pharmaceutical explained that its innovative new drug pipelines, up to 30 of which are designated as RPDs, will be firmly proven to be innovative in the field of rare diseases.
Based on the improved in vivo sustainability and excellent maternal cell growth promotion effects of LAPSGLP-2 Analog, Hanmi Pharmaceutical is developing the drug for once a month administration, which is expected to dramatically improve the quality of life for children and adults suffering from short bowel syndrome.
Currently, Hanmi Pharmaceutical is conducting the first phase of domestic clinical trials of LAPSGLP-2 Analog, and plans to start the second phase of clinical trials in the U.S. and Europe in the second half of this year. LAPSGLP-2 Analog was designated as a rare drug to treat short bowel syndrome by FDA and EMA in Europe in 2019.
Kwon Se-chang, CEO of Hanmi Pharmaceutical, said, "We are continuing to prove innovation in this field, with 13 cases of being designated as rare drugs through pipelines with LAPSCOVERY, a self-development platform technology."
He added, "We will do our best to dramatically improve the quality of life of patients around the world, including infants suffering from rare diseases, through continuous research and development and expansion of adaptability."
Short bowel syndrome is a rare disease that causes malnutrition due to absorption disorders caused by loss of more than 60% of the total small intestine due to congenital or postnatal surgical resection.
In particular, pediatric short bowel syndrome, which is known to occur in about 24.5 out of 100,000 newborns, has a serious impact on childhood and adolescent growth. Due to the total venereal nutrition method, which takes more than 10 hours a day, it is difficult for pediatric patients and their families to live a normal life.
It is also vulnerable to serious side effects such as sepsis and thrombosis caused by infection of injection insertion sites, and has a very low survival rate of less than 50 percent for children.
