Lumen Bioscience, a clinical-stage biopharmaceutical company developing biologic drugs for highly prevalent diseases, and the US Army Medical Research and Development Command (USAMRDC), operating through the Medical Technology Enterprise Consortium (MTEC), announced an agreement to develop a rapid, scalable, and inexpensive biologic drug cocktail to treat gastrointestinal (GI) infection in Covid-19 patients and potentially block disease transmission. Covid-19 is an important force readiness issue for the US military: in a prominent example, the US aircraft carrier Theodore Roosevelt was forced to return to port after an outbreak earlier this year.
The nearly $4 million grant funds rapid development of an oral SARS-CoV-2 treatment and preventative product candidates through FDA Investigational New Drug (IND) submission and initial engineering work for a large-scale cGMP manufacturing plant. By spring 2021 the program aims to initiate Phase 2 clinical trials and complete siting and engineering work for a 1-billion-dose-per-year production facility, with cGMP manufacturing to commence in summer 2021.
“We are pleased to have this opportunity to make a meaningful contribution to the Covid-19 response and to showcase the unique cost efficiency and speed advantages of Lumen’s novel drug development environment,” said Brian Finrow, Lumen’s co-founder and CEO. “This platform builds on 25 years of research by others in the field of camelid antibody engineering, and our unique cGMP manufacturing system makes an important contribution to this legacy: a scalable, cost-effective way to make and deliver these biologic drugs to disease targets in the GI tract.”
It was recognized early in the pandemic that the “respiratory” virus that causes Covid-19 also infects the GI tract. In one widely cited study, a majority of Covid-19 patients presented with both GI and respiratory symptoms, and 25% had only GI symptoms. These symptoms can be both severe and wide-ranging[ii], in some cases requiring surgical resection. GI infection by the virus is also thought to contribute to liver damage and acute respiratory distress syndrome (ARDS), both common long-term symptoms of severe Covid-19. This is not surprising: 25% of MERS cases and 16-73% of SARS cases in the 2002-2003 outbreak also presented with significant GI symptoms, and it is widely accepted that the original 2003 SARS virus transmitted efficiently through the fecal-oral route, a phenomenon that could also explain recurring Covid-19 superclusters. Lumen’s GI-targeted therapy may therefore not only reduce overall viral burden, inhibit disease progression, and accelerate recovery, but also prevent a potentially significant source of Covid-19 transmission.