(Health Korea News / Lee Chung-man) An attempt is being made to develop a drug that can significantly increase the dosing cycle of glucagon-like peptide-1 (GLP-1) agonists, also known as obesity treatments, from once a week to once a month.
GLP-1 is a hormone that acts on the hypothalamus of the brain to make you feel full. GLP-1 agonists selectively act on GLP-1 to reduce hunger and suppress appetite. It was originally designed as a diabetes treatment, but it was positioned as an obesity treatment after it was discovered to be effective in weight loss.
The first GLP-1 agonist anti-obesity drug to be introduced was Saxenda (ingredient name: liraglutide) from Denmark’s Novo Nordisk. The Ministry of Food and Drug Safety of Korea approved Saxenda in July 2017.
‘Saxenda’ is a once-daily injection, and has the inconvenience of having to be administered every day. The follow-up drugs that emerged accordingly are ▲Novo Nordisk’s ‘Wegovy’ (ingredient name: semaglutide) and ▲USA’s Eli Lilly and Company’s ‘Zepbound’ (ingredient name: tirzepatide). The dosing cycle for both drugs is once a week.
‘Wigobi’ and ‘Zepbound’ are attracting attention as they effectively improve the inconvenience of medication for patients compared to ‘Saxenda’, which requires daily injections.
In particular, Ozempic (ingredient name: semaglutide), a once-weekly diabetes treatment drug with the same ingredient as Wigobi, is widely used for off-label indications for weight loss, recording sales of $13.8 billion (about 18.3 trillion won) in 2023, ranking 6th in overall pharmaceutical sales.
Accordingly, there is an analysis that the rise of ‘Wigobi’ and ‘Zepbound’ to blockbuster drugs is a given.
Hanmi Pharmaceuticals Leads Development of Monthly GLP-1 Agonist
However, from the patient’s perspective, the longer the medication cycle, the better. In general, medication compliance increases proportionally with the medication cycle. Once-a-week medication is better than once-a-day medication, and once-a-month medication can increase patient medication compliance than once-a-week medication.
Accordingly, companies have begun developing GLP-1 agonists that can be administered once a month. Novo Nordisk, which currently dominates the GLP-1 agonist market, is also attempting to develop its own once-monthly GLP-1 agonist candidate, ‘NN9650.’
‘NN9650’ is a dual-agent that simultaneously affects GLP-1 and gastrin inhibitory polypeptide (GIP) hormones. Novo Nordisk began phase 1 clinical trials evaluating ‘NN9650’ in Germany in January of this year.
Other than that, nothing specific is known about ‘NN9650’. Novo Nordisk plans to complete the phase 1 clinical trial of ‘NN9650’ in March 2025.
However, Novo Nordisk is a latecomer in the development of monthly GLP-1 agonists, and the current leader in the development of monthly GLP-1 agonists is a Korean company, Hanmi Pharmaceutical. The company’s monthly GLP-1 agonist candidate is ‘efpeglenatide’.
‘Efpeglenatide’ is a GLP-1 agonist that uses Hanmi Pharmaceutical’s proprietary platform technology, ‘Labscovery’. The innovativeness of the drug has been proven through numerous global clinical trials conducted by former partner, French company Sanofi.
In particular, this drug is a GLP-1 agonist that uses Hanmi Pharmaceutical’s proprietary platform technology, ‘Lapscovery’. ‘Lapscovery’ is an innovative platform technology that extends the half-life of protein drugs. Accordingly, the dosing cycle of ‘Efpeglenatide’ is at most once a month.
Hanmi Pharmaceutical is currently raising expectations for the birth of the first monthly GLP-1 agonist by raising the clinical stage of ‘Efpeglenatide’ to Phase 3. The Ministry of Food and Drug Safety approved the Phase 3 clinical trial plan (IND) for ‘Efpeglenatide’ in October 2023.
The trial will evaluate the efficacy and safety of ‘Efpeglenatide’ and placebo in 420 adult obese patients without diabetes at a domestic university hospital. The clinical trial is expected to end in the first half of 2026, and it is expected to be commercialized in Korea within the next three years.
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Source: www.hkn24.com
