Eli Lilly Seeks the US FDA’s EUA for its COVID-19 Antibody Treatment

Shots:

  • Eli Lilly reports additional data on its SARS-CoV-2 neutralizing Ab programs including interim data on combination therapy in diagnosed patients with mild-to-mod. COVID-19 and plans to make therapies available to patients
  • The new analysis P-II BLAZE-1 study assessing LY-CoV555 (2800mg) + LY-CoV016 (2800mg) vs PBO demonstrated reduced viral [email protected] meeting its 1EPs, reduction in symptoms and COVID-related hospitalization and ER visits
  • Based on the combination regimen data, along with the previous findings for LY-CoV555, Lilly has submitted the initial EUA for LY-CoV555 monothx. and plans to initiate a large open-label pragmatic study in COVID-19 outpatients in Oct’2020. Additionally, Lilly anticipates the data supporting BLA submission for dual regimen as early as Q2’21

Click here ­to­ read full press release/ article | Ref: Eli Lilly | Image: GMP News

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Celltrion Initiates P-I Study of its COVID-19 Antibody Treatment in South Korea

Shots:

  • The P-I study follows positive pre-clinical results and the Korean MFDS’ IND approval. The study will enroll ~32 healthy volunteers in collaboration with Chungnam National University Hospital to assess the safety of the antiviral Ab treatment candidate in patients who have not been diagnosed with COVID-19
  • The trial is expected to be completed in Q3’2020. The company plans to conduct a P-I trial of the therapy in mild COVID-19 patients across the EU, including the UK, followed by global P-II/III trials in patients with mild/moderate COVID-19. Celltrion expects preliminary results from pivotal studies by late 2020
  • Additionally, the company will evaluate the treatment for use as a preventative measure and enroll people in close contact with COVID-19 patients globally with its anticipated results in Q1’21. Celltrion’s Ab treatment candidate has demonstrated effectiveness in neutralizing the mutated G-variant strain of SARS-CoV-2 (D614G variant)

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: GMP News