D&D Pharmatech "Confident in MASH and Obesity Drug Efficacy…Targeting 100 Trillion Won Market"

“The GLP-1 obesity treatment market is expected to grow to 100 trillion won( approximately 77 billion dollars) by 2030. Including metabolic-associated steatohepatitis (MASH), the market potential is even larger. D&D Pharmatech is aiming squarely at this market.”

The excitement for the development of 'Glucagon-like Peptide-1 (GLP-1) receptor agonists', well-known through Novo Nordisk's 'Ozempic' and Eli Lilly's 'Zepbound', is heating up in Korea. These drugs are known for their weight loss and blood sugar control effects, and their potential to treat various metabolic disorders, including MASH, is being highlighted.

Major pharmaceutical companies such as Hanmi Pharmaceutical, Dong-A ST, Yuhan Corporation, and ProGen are leading the development of Korean GLP-1 treatments. D&D Pharmatech, which has recently successfully gone public, has emerged as a frontrunner. They were the only Korean company to participate in the first-ever ‘GLP-1 Therapeutics Development Conference’ held in the United States this year.

D&D Pharmatech was founded in 2014 by Lee Seul-ki, a former associate professor of radiopharmaceuticals at Johns Hopkins University School of Medicine and an expert in drug delivery. Last year, their dual-acting candidate 'DD01', which targets both GLP-1 and glucagon, demonstrated efficacy in MASH patients during a Phase 1 clinical trial and was designated as a Fast Track candidate by the U.S. FDA. The company also licensed six pipeline projects, including oral GLP-1 agonists, to their U.S. partner 'Metacera', with the total contract value reaching approximately 1 trillion won.

On the strength of these achievements, D&D Pharmatech went public on the KOSDAQ market last May. With a confirmed IPO price of 33,000 won($25.41), the company's market capitalization at the time of listing was 344.2 billion won, marking a successful debut. On July 11, at the 'BioPlus-Interphex 2024 (BIX2024)' event held in COEX, Seoul, I conducted an on-site interview with CEO Lee Seul-ki, who was a speaker at the event.

"Going public hasn't changed our goals. We are focused on successfully advancing DD01 through Phase 2 clinical trials," said CEO Lee. He anticipates that the global Phase 2 trial for DD01 will begin patient dosing within a few weeks, or by the third quarter at the latest, with interim data expected by the first half of next year.

In the Phase 1 trial, DD01 was administered to 12 MASH patients, and significant efficacy was observed. During the four-week trial with weekly dosing, patients saw their fatty liver index, a key biomarker for MASH treatments, drop by an average of 50% and up to 70%. Considering a clinically effective reduction is 30%, this result is substantial.

"The only regret about the Phase 1 trial is that the follow-up period was very short, only four weeks. While it's encouraging that immediate responses were observed with a few doses, the Phase 2 trial will be conducted over 12 to 48 weeks to verify long-term effects and impacts on patients," explained Lee.

Lee emphasized that while DD01's primary indication is MASH, it does not lag behind other GLP-1 drugs in terms of weight loss efficacy. In preclinical studies on obese monkey models, DD01 demonstrated about 15% weight loss after six weeks of administration. In the Phase 1 trial, patients showed a 2-3% weight loss, which is not far behind dedicated obesity treatments considering it was achieved with only four doses.

Confident in DD01's efficacy, Lee pointed out that numerous preceding studies have shown that weight loss and fatty liver improvement through this treatment also positively impact liver fibrosis. "Discussions with global big pharma interested in DD01 partnerships are well underway. If the expected positive effects are confirmed in Phase 2, the next steps will proceed quickly. We plan to collaborate with capable partners to expedite commercialization, which we foresee being possible around 2030 if the trials go smoothly."

When asked about post-commercialization goals, Lee stated, "It's premature to discuss sales or market share figures. Our focus is on the immediate clinical trials. However, securing just a 5% market share in a market expected to exceed 100 trillion won would generate sales surpassing those of a 'global blockbuster'. Our ambitions are by no means small."