D&D Pharmatech's metabolic dysfunction-associated steatohepatitis (MASH) treatment candidate "DD01" has entered the final stage of phase 2. The next steps are to expand the clinical scope to a next-generation pipeline targeting cirrhosis (F4) patients, dual and triple-action oral therapies in the obesity field, and a degenerative brain disease (CNS) pipeline."
On the 15th (local time), Chief Executive Lee Seul-gi of D&D Pharmatech met with ChosunBiz at the site of the JP Morgan Healthcare Conference (JPMHC 2026) in San Francisco and stated accordingly.
DD01 is a long-acting dual agonist developed in-house by D&D Pharmatech that simultaneously targets glucagon-like peptide (GLP)-1 and the glucagon receptor.
According to the 24-week results of the phase 2 DD01 trial that Chief Executive Lee released at JPMHC that day, the fibrosis-related biomarker (ELFScore) decreased by 3%, showing a significant difference compared with the placebo group (0.4%). Lee said it was encouraging to confirm that, as with the 12-week results, the positive efficacy persisted at 24 weeks.
Lee said, "DD01 has high commercialization potential, including rapid treatment speed, and global pharmaceutical companies, including big pharma, are showing great interest."
Lee explained, "DDO1 provides all the benefits of GLP-1, including blood sugar control and weight loss, while offering strong glucagon activity as a liver-targeting compound," adding, "we achieved the golden ratio between GLP-1 and glucagon activity."
According to Lee, in the DD01 clinical results, fatty liver decreased by an average of 50% in just four weeks at 40 mg and 80 mg doses. All patients given 40 mg saw a reduction of 30% or more in fatty liver, a superior level compared with the effects existing MASH treatments show at a minimum of 24 weeks. By 12 weeks, fatty liver decreased by 62.5% or more. Lee said it was encouraging that, as with the 12-week results, the positive efficacy persisted at 24 weeks.
The key pipeline to follow DD01's performance is TLY012. TLY012 is a recombinant protein therapeutic in the tumor necrosis factor-related apoptosis-inducing ligand family. It selectively acts on the DR5 receptor of myofibroblasts, known as a common cause of various fibrotic diseases such as cirrhosis.
If DD01 mainly targets MASH patients with F2–F3, TLY012 targets patients with F4, the final stage of cirrhosis. Lee said, "For cirrhosis patients, we expect TLY012 to deliver definitive results even with a relatively short course of dosing."
D&D Pharmatech is targeting the oral obesity treatment market by using "oral link," a technology that alters or improves the properties of peptides to make them suitable for oral formulations (pills).
Lee said, "At the end of last year, when Metsera was acquired by Pfizer, our partner changed to Pfizer, and we are strengthening our relationship for joint research and development with Pfizer," adding, "we will expand oral link to take on areas beyond obesity that have strong market potential and unmet need."