1st Patient Dosed in Phase 3 Trial of Batoclimab in China
The first participant has been dosed in a Phase 3 clinical trial testing the efficacy and safety of batoclimab (HBM9161) in people with generalized myasthenia gravis (gMG) in China.
“The first patient first dosing in the phase III study brings us one step closer to deliver the novel therapeutic and we look forward to receiving more evidence soon to support batoclimab as the promising potential novel treatment for gMG patients,” Jingsong Wang, MD, PhD, said in a press release. Wang is the founder, chairman, and CEO of Harbour BioMed, the company developing batoclimab in Greater China.
“For decades, there has been lacking adequate and effective therapies for treating myasthenia gravis patients in China, especially for those refractory patients, patients potentially progressing to life-threatening myasthenic crisis, and patients affected by severe side effects associated with long-term use of current therapies, who are yearning for safe and efficacious novel therapeutics,” Wang said.
MG is caused by self-reactive antibodies (autoantibodies) that erroneously attack certain proteins involved in nerve-muscle communication.
Batoclimab works by blocking the activity of the neonatal fragment crystallizable receptor (FcRn), a protein receptor that normally helps prevent antibodies circulating in the bloodstream from being degraded. By blocking FcRn, batoclimab may lower the levels of MG-driving autoantibodies by increasing the rate at which they are degraded.
Harbour BioMed had previously sponsored a Phase 2 trial (NCT04346888) that tested batoclimab against a placebo in 30 adults with moderate to severe gMG living in China. Data from this trial, announced earlier this year, indicated that the therapy substantially eased MG symptoms and lowered the levels of disease-causing antibodies.
Batoclimab was generally safe and well-tolerated in the study. Most adverse events (side effects) were mild, and there were no serious adverse events or cases of treatment discontinuation due to adverse events.
“Data received from the phase II clinical trial of batoclimab in Chinese gMG patients showed the efficacy of batoclimab over placebo, a favorable safety and tolerability profile,” said Chongbo Zhao, MD, a professor of neurology at Huashan Hospital of Fudan University in Shanghai and principal investigator of the Phase 2 trial.
The findings from this earlier trial show that blocking FcRn “can improve the condition of gMG patients rapidly and significantly,” Zhao said, and that this therapeutic strategy may also be promising in other diseases driven by autoantibodies.
These findings were generally consistent with data from a similar Phase 2a study, called ASCEND MG (NCT03863080), which compared the safety and early efficacy of batoclimab against a placebo in adults with moderate-to-severe gMG living in the U.S. and Canada.
ASCEND-MG was sponsored by Immunovant, the company developing batoclimab for commercialization in the U.S. and Canada under the name IMVT-1401. Immunovant has previously announced plans to launch a potentially pivotal trial of batoclimab in MG, which is expected to start later this year or early next year.
Batoclimab received the designation of breakthrough therapy, which is meant to spur the development of new treatments addressing unmet needs, by Chinese regulatory authorities earlier this year.