DR-10624

Meet the latest Chinese biotech with metabolic assets ready for partnering. Zhejiang Doer Biologics presented mid-stage data that signal that a first-of-its-kind drug is effective at cutting high lipid levels. The biotech is already in discussions with potential Western collaborators. The product, named DR10624, is an injected tri-agonist, hitting the receptors for GLP-1, glucagon and FGF21. In a China-based Phase 2 trial in patients with severe hypertriglyceridemia (sHTG), it cut triglyceride levels by a median of 69% at the highest dose, 50 mg per week, after four months. This was a statistically significant margin over the 8% reduction seen with placebo. Of the patients given DR10624, 90% achieved triglyceride levels below 500 mg/dL, versus 25% with placebo. This essentially means they no longer have sHTG . A reduction in triglycerides of at least 50% was seen in 79% of treated patients, versus 5% given placebo. Both of these differences were statistically significant. Another trial finding points to a second indication Doer Bio has in mind for the asset: MASH. Patients treated with DR10624 had significantly greater reductions in liver fat at Week 12 compared to placebo, at 64% versus 8%. DR10624 was well tolerated in the 79-patient study, with the most common side effects being gastrointestinal or injection site reactions. The data were presented Nov. 8 at the American Heart Association’s annual conference. The tri-agonist approach is intended to maximize the therapeutic effects of the different mechanisms while mitigating their side effects, Doer Bio’s chief operating officer Yongliang Fang told Endpoints News . Combining glucagon and FGF21 agonism could create a more potent lipid-lowering therapy, Fang said. But the glucagon agonist will increase blood glucose — not ideal for a population that often has diabetes or prediabetes. “That’s why we added the GLP-1 component,” Fang said, “to compensate for glucagon activity.” The GLP-1 activity could also have an effect in metabolic disorders like MASH, helping reduce patients’ body weight. The next step in sHTG is Phase 3. “We have to test the therapy in a large-scale patient population for a longer duration of time,” Fang said. Doer Bio is planning to start Phase 3 studies with DR10624 in China around the first quarter of 2026. It has also done some clinical work in New Zealand — a small Phase 2a study in patients with obesity and elevated triglycerides. In those patients, the drug significantly reduced triglycerides and liver fat. “At this moment, we already know that our agonist is super effective in both a Chinese population plus a Western population,” Fang said. Doer Bio is also working towards a Phase 3 sHTG trial in the West. Mixed hyperlipidemia is “an obvious follow-up indication,” Fang said, and the company may pursue investigation into certain cardiovascular disorders in the future. Then there’s MASH. The company is close to fully enrolling a four-month Phase 2 MASH study, which will use non-invasive diagnostics to assess endpoints such as liver fat content. If that trial succeeds, Doer Bio will head into Phase 3 in MASH, too. The asset is not a good fit for obesity, Fang said, as FGF21 agonism increases appetite. The biotech is looking to license rights to DR10624 outside China. “We need to run large-scale studies, with longer duration of time to fully comprehend the safety profile, which takes time, money and resources, and that’s why we believe, potentially, big pharmas will be a good option for partnership,” Fang said. He added that Doer Bio is also open to working with biotechs, or forming joint ventures. “As long as they can advance this program further into clinical development, we’re interested in talking,” he said. Doer Bio itself was founded in 2014, Fang said, and was initially backed by local investors plus some VC firms. In 2021, Hangzhou, China-based Huadong Medicine acquired 75% of Doer’s share equity. Despite this, Doer operates independently, with its own board of directors, management team and research and development capacities. It has several other assets in its pipeline, including a GLP-1/GIP agonist and a GLP-1/GIP/glucagon agonist. The latter has a short half-life, and development has been halted so Doer Bio can work on making it suitable for weekly dosing. Doer Bio also has three cancer assets, including a PD(L)1xVEGFxTGFβ trispecific, in early development for solid tumors.