sonefpeglutide (HM15912) / Hanmi - LARVOL DELTA

Hanmi’s new drug for short bowel syndrome gains WHO recognition as 'sonefpeglutide' (Korea Biomedical Review) - "Hanmi Pharmaceutical said Monday that the International Generic Name (INN) of its new drug candidate for short bowel syndrome, LAPS GLP-2 analog (HM15912 in development name), has been finalized as 'sonefpeglutide'. Officially listed by the World Health Organization (WHO), sonefpeglutide is a compound of the prefix 'ef-', which refers to the protein to which Hanmi Pharmaceutical's proprietary platform technology 'Lapscovery' was applied, and the suffix '-glutide', which refers to a glucagon-like peptide analog. In the future, all products containing this ingredient will use the generic name sonefpeglutide."

Clinical • Short Bowel Syndrome

Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: Hanmi Pharmaceutical Company Limited | Trial completion date: Dec 2025 ➔ May 2028 | Trial primary completion date: Dec 2025 ➔ Dec 2027

Trial completion date • Trial primary completion date • Gastrointestinal Disorder • Short Bowel Syndrome

Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function (clinicaltrials.gov) - P1 | N=16 | Completed | Sponsor: Hanmi Pharmaceutical Company Limited | Recruiting ➔ Completed | N=32 ➔ 16

Enrollment change • Trial completion • Renal Disease

HM15912: Data readout from P2 trial (NCT04775706) for SBS associated intestinal failure in 2025 (Hanmi) - Q3 IR Presentation

P2 data • Short Bowel Syndrome

Hanmi presents study on short bowel syndrome drug's potential as GVHD treatment in Europe (Korea Biomedical Review) - "Hanmi Pharm has suggested that the company could develop HM15912, its short bowel syndrome treatment candidate developed as a once-monthly dosage form, as a treatment for another rare disease, graft-versus-host disease (GVHD)...Hanmi said Thursday that it presented two posters on the research results of HM15912 at the European Society for Clinical Nutrition and Metabolism (ESPEN Congress 2023) held in Lyon, France, from Monday to Thursday...In this study, Hanmi demonstrated significant improvements in GVHD scores and survival with HM15912 for both prophylactic and therapeutic use in animal models of GVHD...In another study, HM15912 treatment improved both GVHD score and survival in an animal model of GVHD that was not responsive to steroids."

Preclinical • Acute Graft versus Host Disease • Graft versus Host Disease

HM15912, a Novel Long-Acting GLP-2 Analog, Improves Intestinal Growth and Absorption Capacity in Rat Model of Short Bowel Syndrome (ENDO 2023) - "Although teduglutide was firstly approved, the widespread use of it is still limited due to insufficient efficacy and leading to a significant burden for patients by daily administration. Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Preclinical • Gastrointestinal Disorder • Short Bowel Syndrome • IGF1

Beneficial Effect on Intestinal Growth of a Long-Acting GLP-2 Analog, HM15912, after Treatment Switching from Conventional GLP-2 Drug or Other Long-Acting GLP-2 Analogs under Clinical Development in Animal Model (ENDO 2023) - "The widespread use of teduglutide, which is only approved GLP-2 analog drug for short bowel syndrome (SBS), may be still limited due to insufficient efficacy and leading to a significant burden for patients by daily administration...Next, we synthesized GLP-2 analogs to have same sequences with glepaglutide and apraglutide...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*"

Preclinical • Gastrointestinal Disorder • Short Bowel Syndrome

Hanmi Pharmaceutical’s share price ’sniffly’ on the possibility of developing a new drug administered once a month for short bowel syndrome [Google translation] (Pinpoint News) - P=NA | N=NA | "The company will participate in the World Endocrine Society held in Chicago, USA, and present major research results of two rare disease treatment candidates, including short bowel syndrome treatment, which is being developed as a once-a-month dosage form for the first time in the world....When the daily or once-a-week treatment regimen was administered and the monthly regimen was changed to LAPS GLP-2 analog, superior efficacy was observed. This is the result of not only reducing the frequency of dosing for patients who previously received daily medication, but also proving the effect of promoting additional small intestine growth."

Clinical data • Gastrointestinal Disorder • Immunology • Short Bowel Syndrome

Phase 1 PK Study to Assess Safety, PK, Tolerability of HM15912 in Subjects With Renal Impairment and Normal Renal Function (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: Hanmi Pharmaceutical Company Limited

New P1 trial • Renal Disease

HM15912, a Novel Long-acting G lucagon-like Peptide-2 Analog, Improves Intestinal Growth and Absorption Capacity in a Male Rat Model of Short Bowel Syndrome. (PubMed, J Pharmacol Exp Ther) - "Teduglutide is the only approved glucagon-like peptide-2 (GLP-2) drug for SBS; however, it requires daily administration. Significance Statement HM15912, a novel long-acting GLP-2 analog, has a significant small bowel hypertrophic effect in rodents with a reduced frequency of administration compared to the existing GLP-2 analogs on the market or currently under clinical development. This study supports the possibility that HM15912 could be administered much less frequently than other long-acting GLP-2 analogs for patients with SBS."

Journal • Preclinical • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Oncology • Short Bowel Syndrome

Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects (clinicaltrials.gov) - P2 | N=18 | Recruiting | Sponsor: Hanmi Pharmaceutical Company Limited | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Trial completion date • Trial primary completion date • Gastrointestinal Disorder • Short Bowel Syndrome

Hanmi Pharm unveils three clinical trials of ’HM15912’, an innovative new drug based on Labscovery in Europe [Google translation] (E-Today) - "Hanmi Pharm recently conducted a global phase 2 clinical trial of 'LAPSGLP-2 analog (HM15912)', a new drug for short bowel syndrome, which is being developed as an innovative new drug based on its Labscovery in Europe, and two preclinical studies that confirmed the possibility of development as a treatment for inflammatory bowel disease....it will provide information on clinical design, subject selection criteria, clinical period, target values, etc. The details were introduced in a poster presentation....Hanmi Pharm also conducted oral and poster presentations confirming the possibility of treating inflammatory bowel disease in the combination of 'HM15912 + efeglenatide' in animal models."

Clinical • Preclinical • Inflammatory Bowel Disease • Short Bowel Syndrome

Korea and the US to introduce a phase 2 clinical trial for an innovative new drug for short bowel syndrome administered once a month in Europe [Google translation] (Cheonji Ilbo) - "Hanmi Pharm will hold the global phase 2 clinical trial of 'LAPSGLP-2 Analog (HM15912)', an innovative new drug for the treatment of short bowel syndrome, which is being developed as the world's first once-a-month dosage form, to be held in Vienna, Austria from the 3rd to the 6th of next month. It was announced on the 31st that it will be presented as a poster at the European Society for Clinical Nutrition and Metabolism (ESPEN). In this presentation, Hanmi Pharmaceutical announced the clinical design, clinical subject selection criteria, clinical period, and target number under the theme of 'The ongoing phase 2 clinical trial of a new GLP-2 analogue (HM15912) for patients with short bowel syndrome-intestinal failure (SBS-IF)'."

Trial status • Short Bowel Syndrome

Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects (clinicaltrials.gov) - P2 | N=7 | Recruiting | Sponsor: Hanmi Pharmaceutical Company Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Disorder • Short Bowel Syndrome

Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects (clinicaltrials.gov) - P2; N=7; Not yet recruiting; Sponsor: Hanmi Pharmaceutical Company Limited; Initiation date: Oct 2021 ➔ Jan 2022

Clinical • Trial initiation date • Gastrointestinal Disorder • Short Bowel Syndrome

Hanmi Pharmaceutical to start domestic clinical trials for short bowel syndrome treatment [Google translation] (Health Korea News) - "Hanmi Pharmaceutical has begun domestic clinical trials of its short bowel syndrome drug candidate, 'LAPSGLP-2 Analog' (HM15912), and interest in the possibility of developing a treatment is growing....The Ministry of Food and Drug Safety recently approved a phase 2 clinical trial for Hanmi Pharm's HM15912. This is a trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of 'HM15912' in adult patients with short bowel syndrome (SBS)-related bowel failure (SBS-IF). It is known that the total number of subjects in this clinical trial was 7, and the number of domestic subjects was 2."

Trial status • Short Bowel Syndrome

Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects (clinicaltrials.gov) - P2; N=7; Not yet recruiting; Sponsor: Hanmi Pharmaceutical Company Limited; Initiation date: Jun 2021 ➔ Oct 2021

Clinical • Trial initiation date • Gastrointestinal Disorder • Short Bowel Syndrome

Hanmi confirms efficacy of short bowel syndrome treatment candidate (Korea Biomedical Review) - "Hanmi Pharmaceutical said that it has confirmed the efficacy of LAPSGLP-2 Analog, a short bowel syndrome treatment, and published the study results during the 2021 European Society for Clinical Nutrition and Metabolism (ESPEN)...According to the study's results published this time, the growth and absorption of the small intestine increased in the group administered with LAPSGLP-2 Analog compared to the model taking the only treatment for short bowel syndrome that needs daily or weekly administration."

Preclinical • Gastrointestinal Disorder • Short Bowel Syndrome

Hanmi’s short bowel syndrome drug wins FDA fast track designation (Ajunews Buisness Daily) - "Hanmi Pharmaceutical's rare drug for the treatment of short bowel syndrome has won 'fast track' designation from the U.S. Food and Drug Administration (FDA)....Hanmi Pharmaceutical, a major drug maker in South Korea, said it would start second-phase clinical trials abroad soon to test the efficacy of its drug LAPSGLP-2 Analog code-named HM15912."

Fast track designation • Short Bowel Syndrome

Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects (clinicaltrials.gov) - P2; N=7; Not yet recruiting; Sponsor: Hanmi Pharmaceutical Company Limited

Clinical • New P2 trial • Gastrointestinal Disorder • Short Bowel Syndrome

Hanmi Pharmaceutical expects U.S. FDA approval for 2 new drugs (PRNewswire) - "Hanmi Pharmaceutical Co., Ltd. plans to create a global R&D achievement based on innovations of inflammation–fibrosis treatment...rare disease fields....Hanmi Pharmaceutical Co., Ltd. also plans to focus on...LAPSGLP-2 Analog, which is being developed as a treatment for short bowel syndrome, that occurs in three per million, confirmed its safety and once-a-month dosing potential in the first-in-human, phase 1....It will enter a Phase 2 clinical trial this year."

New P2 trial • P1 data • Short Bowel Syndrome

Hanmi Pharm approves phase 2 treatment for hyperinsulinemia and short bowel syndrome [Google translation] (Biospectator) - "Hanmi Pharm announced on the 21st that the US Food and Drug Administration (FDA) approved phase 2 clinical trials for the glucagon agonist...GLP-2 agonist 'HM15912'....For short bowel syndrome."

IND • Short Bowel Syndrome

Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects (clinicaltrials.gov) - P1; N=40; Completed; Sponsor: Hanmi Pharmaceutical Company Limited; Recruiting ➔ Completed; Trial completion date: Apr 2021 ➔ Nov 2020

Clinical • Trial completion • Trial completion date

Single Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15912 in Healthy Korean Subjects (clinicaltrials.gov) - P1; N=40; Recruiting; Sponsor: Hanmi Pharmaceutical Company Limited; Not yet recruiting ➔ Recruiting; Trial completion date: May 2020 ➔ Apr 2021; Trial primary completion date: May 2020 ➔ Oct 2020

Clinical • Enrollment open • Trial completion date • Trial primary completion date

’HM15912’, a treatment for short-term syndrome of Hanmi Pharm, is designated as a rare drug by FDA [Google translation] (Health Korea News) - "Hanmi Pharm is a new biomedicine for treating short-term syndrome.'LAPSGLP-2 Analog' (HM15912) was designated as a rare pediatric disease drug (RPD) by the US Food and Drug Administration (FDA) said....Currently, Hanmi Pharm is conducting a phase 1 clinical trial in Korea for'LAPSGLP-2 Analog' as an indication for short-term syndrome, and is planning to start phase 2 clinical trials in the US and Europe in the second half of this year."

FDA event • New P2 trial • Short Bowel Syndrome