MindRank has shared the skinny on its oral GLP-1 receptor agonist, publishing data from a Chinese phase 2b obesity trial that suggests efficacy is in the same ballpark as Eli Lilly’s orforglipron.
Investigators randomized 317 adults to receive one of four doses of oral GLP-1 candidate MDR-001 or placebo. The drug candidate was given twice a day, putting it at a disadvantage against once-daily rivals such as orforglipron. That drawback aside, the phase 2b data paint MDR-001 as a molecule that can hold its own in the oral obesity space.
Mean body weight reductions after 24 weeks ranged from 8.2% to 10.3% in the MDR-001 cohorts, versus 2.5% in the placebo arm. The range overlaps with data from Lilly, which reported 8.6% to 12.6% weight loss in a phase 2b trial of orforglipron.
MindRank said 70.9% to 85.4% of patients achieved at least 5% weight loss. Between 34.5% and 48.1% achieved at least 10% weight loss. In Lilly’s phase 2b trial, up to 90% and 71% of patients, respectively, lost at least 5% and 10% of their body weight.
While weight loss was greater in Lilly’s trial, the Big Pharma’s patients had been taking orforglipron for two weeks longer and were 20% heavier than MindRank’s participants at baseline. Weighing patients after 26 weeks, compared to 24 weeks in the MDR-001 study, could account for some of orforglipron’s seeming advantage because weight loss on GLP-1 drugs deepens over time.
MindRank avoided the safety problems that scuttled Pfizer’s oral GLP-1 program. The biotech reported no evidence of transaminase elevation, even among the roughly 20% of participants with pre-existing liver impairment. Pfizer dropped its oral GLP-1 prospect in April after seeing potential drug-induced liver injury in a phase 1 trial. The Big Pharma has discussed striking a deal to re-enter the race.
Zhangming Niu, CEO of MindRank, said in a statement that the biotech “is rapidly advancing preparations for global phase 3 trials” and exploring “once-daily dosing regimens to enhance patient convenience.” Lilly and Novo are leading the oral GLP-1 race in the U.S. The FDA is reviewing a filing for approval of an oral version of Novo’s Wegovy. Lilly is aiming to file for approval of orforglipron this year.