Boehringer Ingelheim Focuses COVID-19 Clinical Research on Alteplase

• Analysis of first part of the TRISTARDS study (Phase 2b) investigating alteplase in patients with COVID-19 acute respiratory distress syndrome (ARDS) supports further development
• Phase 3 part of TRISTARDS to be initiated in Q4 2021
• SARS-CoV-2 neutralizing antibody development discontinued in light of evolving landscape including vaccination success and emerging variants

Ingelheim, Germany 26 July 2021 – Boehringer Ingelheim today announced its decision to focus its COVID-19 therapy research on the development of alteplase as a potential treatment for COVID-19 patients with severe breathing problems, called acute respiratory distress syndrome (ARDS). The decision is based on favorable safety and efficacy data from an interim analysis of the TRISTARDS Phase 2/3 study, following completion of the Phase 2b part of the study including 62 patients.

Boehringer Ingelheim is now working towards starting the Phase 3 part of TRISTARDS in Q4 of this year to confirm and further investigate the effects of alteplase in patients with COVID-19 ARDS and prepare for potential submission for approval. 

“If the Phase 3 part of TRISTARDS confirms the favorable interim results from the Phase 2, alteplase could have the potential to become a new therapy option for the most severely affected COVID-19 patients”, said Michel Pairet, member of Boehringer Ingelheim’s Board of Managing Directors with responsibility for the company’s Innovation Unit. 

Due to the evolving SARS-CoV-2 landscape including vaccination success, existing neutralizing antibody programs and emerging variants, Boehringer Ingelheim has decided to fully concentrate on the development of alteplase moving forward. The aim is to help hospitalized patients at the earliest possible time to avoid worsening of ARDS-related damages and to reduce the treatment burden in intensive care units. The BI 767551 SARS-CoV-2 neutralizing antibody development program will be discontinued, as the current state of the pandemic makes it challenging to further progress clinical development of this antibody and make it available to patients within a reasonable time frame to contribute against the COVID-19 pandemic. The development of the SARS-CoV-2 neutralizing antibody included trials investigating the delivery via inhalation. In principle, this new concept for antibody treatment could be a feasible form of application which may offer the potential to provide a faster onset of activity by targeting the site of infection and, simultaneously a convenient route of administration.

TRISTARDS study
The TRISTARDS study was initiated following investigator-initiated studies pointing towards a potential role of alteplase in the treatment of COVID-19 ARDS in severely ill patients. The Phase 2b part of TRISTARDS was an exploratory open label study with 62 randomized COVID-19 ARDS patients. It evaluated efficacy and safety of two different dosing regimens of intravenous alteplase given for up to 5 days on top of best available medical management (standard of care (SOC)), compared with SOC alone.

Alteplase
Alteplase (Actilyse^®) is the only licensed blood clot dissolving treatment (thrombolytic) for acute ischemic stroke therapy, which is used in many stroke centers. In addition, it can be used for the treatment of acute myocardial infarction, acute massive pulmonary embolism and catheter clearance due to thrombotic occlusion (indications vary across countries). 

The benefit-risk profile of alteplase in COVID-19 ARDS is yet to be determined in further detail. It is not approved to treat COVID-19 and should therefore only be used in approved indications for which the benefit-risk profile is well-established.

Boehringer Ingelheim
Boehringer Ingelheim is working on breakthrough therapies that improve the lives of humans and animals. As a leading research-driven biopharmaceutical company, the company creates value through innovation in areas of high unmet medical need. Founded in 1885 and family-owned ever since, Boehringer Ingelheim takes a long-term perspective. Around 52,000 employees serve more than 130 markets in the three business areas, Human Pharma, Animal Health, and Biopharmaceutical Contract Manufacturing. 

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