Maike Pharmaceutical-B (02335): MT200605 phase II clinical trial for acute ischemic stroke (AIS) reached the main end

Zhitong Finance App News, McMedicine-B (02335) announced that the Phase II clinical trial (this clinical trial) of MT200605, a drug candidate developed independently by the Group to treat AIS (this clinical trial), has obtained top-line data. The data shows that the clinical trial has reached its main research endpoint, and the results are statistically significant and clinically significant.

This clinical trial is a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy, safety and pharmacokinetics of MT200605. A total of 360 subjects were enrolled.

The analysis of the results showed that:

In terms of efficacy, data on the main efficacy endpoints (90-day MRs 0-1 percentage) showed that the efficacy of MT200605 was higher than that of the placebo group. Compared with placebo, patients had more than 100% advantage of getting good functional outcomes. Logistic regression model analysis showed that the differences between the high dose group and the placebo group were statistically significant. The secondary efficacy endpoints also showed the same efficacy trend.

In terms of safety, MT200605 was safe and well tolerated. There were no serious adverse events (SAE) associated with the test drug during the entire study period. Adverse events (TEAE) greater than or equal to grade 3 were balanced across groups, and no new significant safety risks were found.

Overall, MT200605 showed remarkable and stable efficacy in ischemic stroke patients, and was safe and well tolerated.

According to our knowledge, MT200605 is the only neuroprotective drug in the world that can cross the blood-brain barrier (BBB), acts as an agonist of BDNF/TrkB, and relieves microcirculation obstruction caused by calcium-induced smooth muscle contraction, thereby completely blocking ischemic cascade damage induced after ischemic stroke, while promoting nerve regeneration and remodeling.

The company cooperated with Beijing Tiantan Hospital affiliated to Capital Medical University to participate in the “R&D and Clinical Trials of Innovative Drugs for the Prevention and Treatment of Cardiovascular Embolic Diseases” project, which is a major national science and technology project for innovative drug research and development. The company mainly undertakes research work related to clinical development and test verification of MT200605 (TrkB small molecule agonist) for patients with acute ischemic stroke, with the aim of evaluating its efficacy and safety.

In addition to being used to treat acute ischemic stroke (AIS), MT200605 is also being developed to treat Huntington's Disease (HD). MT200605 can selectively activate the TrkB signaling pathway and exert both neuroprotective and antioxidant effects to protect the structure and function of nervous tissue. Preclinical studies have shown that MT200605 has the potential to directly reduce the aggregation of mutant huntington protein (mHTT), thereby providing a treatment strategy with potential disease-modifying effects for HD. In March 2026, MT200605 was officially certified as an orphan drug by the US Food and Drug Administration (FDA) for HD indications.