Hanmi’s 2 new accounts of the pipeline enter clinical trial

Hanmi strives to conquer obesity

HM15275 enters full-scale clinical trials…second to efpeglenatide

Hanmi Pharm aims to enter clinical trials of its latest 3 novel candidate products through H.O.P project

Hanmi Pharm is accelerating the development of new obesity drugs.

 

Following efpeglenatide, which has entered the Phase 3 trial in South Korea, Hanmi Pharm’s other new drug candidate has entered the full-scale clinical trial.

 

Furthermore, Hanmi Pharm plans to establish various pipelines, including an oral agent, digital therapy related to obesity prevention and management, and eating disorder treatment.

 

According to Hanmi Pharm on May 13, the U.S.

 

Food & Drug Administration (FDA) has granted approval for a Phase 1 study of HM15275.

 

HM15275 is a new drug candidate that simultaneously targets glucagon-like peptide-1 (GLP-1)/ glucose-dependent insulinotropic polypeptide (GIP)/glucagon for the treatment of obesity.

 

Hanmi Pharm plans to maximize drug’s effect by simultaneously targeting GLP-1, GIP, and glucagon.

 

GLP-1 and GIP are the active ingredients of Saxenda and Wegovy.

 

Patients with diabetes and obesity typically have reduced incretin, and the disorders are associated with a reduction in GLP-1 secretion and decreased GIP-mediated stimulation of insulin secretion.

 

GLP-1 and GIP are hormones responsible for 2/3 of the post-meal insulin response.

 

Currently, Zepbound is available in the market as a dual agonist of GLP-1·GIP.

 

However, a triple agonist that also includes glucagon has not been made available in the market.

 

Hanmi Pharm aims to launch a first-in-class drug in this field.

 

Hanmi Pharm’s pipeline efpeglenatide and HM15275 have entered clinical trials.

The clinical trials will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics profile in healthy adults and patients with obesity.

 

Furthermore, Hanmi will disclose four accounts of preclinical trial results related to HM15275 at the American Diabetes Association 2024 (ADA 2024) meeting.

 

The company anticipates that HM15275 will be as effective as surgical therapy’s weight loss outcome (about 25%).

 

Efpeglenatide proceeded to a Phase 3 trial…other pipeline underway To focus on developing novel obesity drugs, Hanmi Pharm has launched H.O.P.

 

project.

 

The company aims to secure various pipelines, including digital therapy and obesity drugs to improve feeding disorders.

 

Hanmi Pharm

Efpeglenatide, which has entered the Phase 3 trial, is the closest among these to be marketed.

 

In October of last year, the Ministry of Food and Drug Safety (MFDS) granted approval for a Phase 3 trial of Hanmi’s obesity drug of GLP-1 class, efpeglenatide.

 

The Phase 3 trial, being conducted in university hospitals in South Korea, will evaluate the efficacy of efpeglenatide.

 

It will be a randomized, double-blind, placebo-controlled, parallel-group comparison study, enrolling 420 adult patients with obesity without diabetes.

 

Efpeglenatide is a new candidate product that initially struck a licensing agreement with Sanofi in 2015 but returned to Hanmi Pharm in 2020.

 

Sanofi was developing efpeglenatide but returned the right after the company changed its business strategy.

 

Hanmi Pharm plans to develop efpeglenatide as an optimized GLP-1 class obesity treatment for Koreans.

 

In a global trial, efpeglenatide was effective in weight loss and adjusting blood sugar.

 

Because global companies have developed GLP-1 obesity treatments based on the standard of westerners with severe obesity, Hanmi Pharm has set a goal to develop a treatment optimized to the Korean obesity standard, which considers a body mass index (BMI) of 25kg/㎡.

 

Efpeglenatide has been developed as a once-weekly dosing of injection.

 

It is expected to have the same competitiveness as Wegovy (ingredient: semaglutide) and Zepbound (ingredient: tirzepatitide).

 

Saxenda (liraglutide) is formulated for once-daily administration.

 

Additionally, Hanmi Pharm plans to develop obesity treatments that minimize muscle loss and inhibit weight regain.

 

In fact, previous research results show that two-thirds of the patients gain weight after they stop taking obesity treatments.

 

Therefore, the quality of weight loss is an important factor for latecomers.

 

Hanmi Pharm plans to develop treatments that overcome this issue.

 

The company is currently seeking candidate products.

 

Hanmi Pharm plans to develop an oral GLP-1 treatment for obesity.

 

Most current GLP-1 treatments for obesity are administered as once-daily or once-weekly injections, but an oral treatment would provide more convenience to patients.

 

Furthermore, Hanmi Pharm plans to develop a new biological drug that can improve eating disorders, such as binging, and a digital therapy that can be used for preventative measures of obesity through making adjustments to daily habits.