Express | To benefit more stroke patients, Bojian capsule gets a new generation of thrombolytic therapy

▎ WuXi AppTec content team editor May 12, 2021, Biogen and TMS jointly announced that Biogen will exercise the option to acquire TMS, a drug under development for the treatment of acute ischemic stroke (AIS) from TMS -007.

This acquisition is based on the positive results of TMS-007 in Phase 2a clinical trials.

TMS-007 has achieved the main safety goals and has a positive effect on the patient's cerebral vascular patency and functional recovery.

Dr.
Alfred Sandrock, head of research and development of Bojian Company, said that in the past 25 years, no new thrombolytic drug has been approved for the treatment of acute ischemic stroke.
This innovative treatment is expected to expand the patient population who can receive thrombolytic drug treatment.

Stroke is a debilitating and even fatal cerebrovascular event.

It is the second leading cause of death in the world, with approximately 13 million cases and 5.
5 million deaths worldwide every year.

Stroke survivors can also experience permanent functional deficits due to irreversible brain damage.

Acute ischemic stroke (AIS) accounts for approximately 85% of the total number of stroke patients.

The current commonly used thrombolytic agent is tissue-type plasminogen activator (tPA), and its mechanism of action is to dissolve blood clots that block blood flow in the brain.

However, it may increase the risk of bleeding in patients, and symptomatic intracranial hemorrhage (sICH) is currently the most terrible complication of thrombolytic therapy.

Within the 9-hour window of stroke, the incidence of sICH in patients treated with tPA in clinical studies can be as high as 6%.

Image source: 123RFTMS-007 is a small molecule plasminogen activator, which has a potential new mechanism of action in decomposing blood clots, and can inhibit local inflammation caused by thrombosis and restore blood flow after acute stroke.

This unique mechanism makes TMS-007 a "best-in-class" thrombolytic agent for the treatment of AIS patients.
Compared with currently approved thrombolytic drugs, it can extend the therapeutic window.

Bojian’s decision to acquire TMS-007 is based on positive data from a Phase 2a clinical trial.

This multi-center, single-dose, randomized, double-blind, placebo-controlled, dose-escalation trial aims to evaluate the safety and efficacy of a single intravenous infusion of TMS-007 within 12 hours after the onset of stroke in AIS patients .

The trial also included AIS patients 12 hours after the onset of illness, who were no longer suitable for treatment with approved tPA or thrombectomy.

The results of the trial showed that TMS-007 reached the primary end point of safety.
There were no safety events in patients treated with TMS-007, and the proportion of patients in the placebo group with safety events was 3%.

At the same time, after 90 days of treatment, 40% of the patients in the TMS-007 group reached the standard of living independently without obvious symptoms or significant disability after stroke.

In the placebo group, this value was 18% (p<0.
05).

Bojian is currently evaluating the next steps in clinical development of TMS-007, including plans to conduct global clinical studies.

The final data of the Phase 2a clinical trial is expected to be announced in future scientific forums.

Reference: [1] Biogen Announces Exercise of Option to Acquire the Investigational Drug TMS-007 for Acute Ischemic Stroke Based on Positive Phase 2a Data.
May 12, 2021, from https://investors.
biogen.
com/news-releases/ news-release-details/biogen-announces-exercise-option-acquire-investigational-drug Note: This article aims to introduce the progress of medical and health research, not a treatment plan recommendation.

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