TAIPEI, , June 13, 2019 /PRNewswire/ -- Lumosa Therapeutics (Lumosa; code: 6535.TWO) announced that the company is ready to commence the Phase 2 proof of concept (PoC) study for its LT3001, a novel drug for the treatment of acute ischemic stroke (AIS) that showed good safety, tolerability and pharmacokinetic profiles in its Phase 1 study, as the US FDA has no objections during the 30-day reviewing period on the company's Investigational New Drug (IND) application. Lumosa is also actively seeking global partners for co-development for this project.
LT3001 is a novel small molecule for the treatment of acute ischemic stroke. Animal studies have demonstrated LT3001's multiple functions in restoring cerebral blood flow and reducing ischemic/reperfusion injury. Lumosa has established the safety, tolerability and pharmacokinetic exploration of LT3001 through the completion of the Phase 1 trial involving 16 healthy volunteers.
Results of the single-dose escalation of LT3001 administered through intravenous injection to the healthy subjects showed that LT3001 was well tolerated without any adverse events. However, mild headache was observed in one subject in the high-dose group but the symptom was relieved in a short time.
In terms of pharmacokinetic analysis, blood concentration of LT3001 in low-dose subjects is higher than that of the effective dose calculated using animal models. Dose selection of LT3001's Phase 2 PoC study will be based on the above results.
After reviewing these promising data, Lumosa decided to submit the Phase 2 IND to the US FDA on May 9, 2019. The regulation states that after accepting the application, the agency has 30 days to review the documents. As the FDA made no requests for clarifications or indicated that the study is placed on clinical hold during the reviewing period, the application became effective automatically. Lumosa plans to conduct the Phase 2 study following the approved protocol.
To accelerate subject enrollment, Lumosa will recruit patients in Taiwan and the US. An IND application containing the protocols that was sent to the US FDA will be submitted soon to Taiwan FDA for approval.
Should the development proceed as planned, Lumosa will initiate the clinical trial in the US by Q3 or Q4 of 2019; for Taiwan, patient enrollment will start in 2020. Subject recruitment is expected to take two years to complete; however, the definite time of completion will depend on the actual outcome.
Brain stroke is one of several diseases that the medical community is trying urgently to resolve. Each year, there are about 15 to 17 million people in the world suffering stroke; among which, 80% of the patients are ischemic. The current treatment for acute ischemic stroke (AIS) is a thrombolytic agent named rt-PA. Unfortunately, the benefit of rt-PA is limited due to its high risks involving hemorrhage and short treatment time window, and only 3%~5% AIS patients are treated with thrombolytics.
Intra-arterial thrombectomy (IAT) was introduced in 2015 but is only for patients with large-vessel occlusion. Because a handful of hospitals are fitted with proper equipment and well-trained staffs to perform this procedure, the number of patients who can benefit from this procedure is low.
Should LT3001 be able to address the limitations of current treatment regimen and achieve the target of treating 50% stroke patients set by the World Health Organization (WHO), the market size for LT3001 may reach as high as US$15 billion.
"Drugs that treat AIS have reached bottleneck as they've failed to address both the safety issue and efficacy at the same time," says Lumosa's president and CEO, Mr. Rong-Chin Lin. LT3001's progression into Phase 2 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 materialize LT3001's intellectual value.
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