Taiwan-based Lumosa Therapeutics is set to launch a Phase II proof of concept clinical trial to evaluate its drug candidate LT3001 in patients with acute ischemic stroke (AIS).
The company submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) and did not receive any objections during the 30-day reviewing period.
Lumosa is currently seeking global partners to co-develop this project.
LT3001 is a small molecule that demonstrated functions to restore cerebral blood flow and minimise ischemic / reperfusion injury in animal models.
The compound’s safety, tolerability and pharmacokinetic profiles have been validated in a 16-subject Phase I study.
When a single-dose escalation was given intravenously, LT3001 was observed to be well-tolerated without any adverse events. One volunteer in the high-dose arm reported having a mild headache.
Dose selection for the Phase II trial will be based on the finding that LT3001’s blood concentration in low-dose subjects is higher than the effective dose determined in animal studies.
Lumosa intends to initiate the new study in the US by the third quarter or fourth quarter of this year, following the approved protocol.
In order to accelerate recruitment, the company also plans to enrol patients in Taiwan. Lumosa will file an IND application to Taiwan FDA in the near future.
Enrolment in Taiwan is scheduled to begin next year.
Lumosa Therapeutics president and CEO Rong-Chin Lin said: “LT3001's progression into Phase II clinical trial is a significant milestone in Taiwan's new drug development history. Judging from the results of the completed studies, LT3001 has the great potential to overcome the above-mentioned obstacles.
“Lumosa will actively seek co-development partners for LT3001 in the world to share development risks, and soon materialise LT3001's intellectual value.”
Patient enrolment into the Phase II trial is expected to be completed in two years.