Hanmi Pharm said Tuesday it participated in a symposium organized by Congenital Hyperinsulinism International (CHI) in The Hague, Netherlands, from Sept. 22-24 to introduce its LAPS GLP-2 analog, HM15912, under development to treat the disease.

CHI is a non-profit organization founded in 2005 to improve the lives of patients with congenital hyperinsulinemia. It holds family gatherings every year to share the latest treatments and clinical status with physicians, researchers, and other experts, building a relevant network.

According to Hanmi, congenital hyperinsulinemia is a rare disease with an incidence of one in 25,000 to 50,000 births, primarily in the neonatal period, that causes persistent low blood sugar. There is only one approved treatment. However, the response rate is low, and patients are forced to use off-label drugs or resort to pancreatectomy.

In an effort to overcome the limitations of existing therapies, Hanmi is developing HM15136 in a once-weekly formulation and conducting a global phase 2 clinical trial. The company expects that the development of HM15136 will significantly alleviate patient suffering, providing continuous therapeutic effect, safety, and dosing convenience.

Hanmi said European medical professionals attending the CHI patient meeting highly evaluated the potential and innovation of HM15136.

"HM15136 has a clear advantage in the ease of administration over competing drugs administered by infusion pump," said Professor Indi Banerjee in Royal Manchester Children's Hospital, U.K. "Patients who have received it have shown good efficacy with no significant adverse events, and patients and families have expressed great satisfaction."

Professor Klaus Mohnike at Otto von Guericke University of Magdeburg, Germany, said, "Patients treated with HM15136 showed stable efficacy with no significant side effects. Current standard treatments have several side effects and poor efficacy, so HM15136 shows promise as a disruptive new drug."

The event also offered children, adolescents, and their families affected by congenital hyperinsulinemia an opportunity to share their experiences of pain and suffering with other participants, fostering empathy and understanding of this rare disease. Hanmi has been sponsoring the CHI Patient Association since 2020.

"Through face-to-face conversations with people with congenital hyperinsulinemia, I could better understand and empathize with their suffering," said Noh Young-su, head of Clinical Research and Development at Hanmi Pharm, who participated in the event. "We will do our best to commercialize HM15136 as soon as possible."

Another Hanmi official said, "Rare diseases are an area where we can practice our management philosophy of ‘respect for humanity and value creation,' and as a pharmaceutical company that exists for the betterment of humanity, we must take care of them."

The company will focus all of its capabilities on developing innovative new drugs that can give hope to patients around the world who suffer from rare diseases, the official added.