Covid-19 roundup: Eli Lilly retrofits RVs for first-of-its-kind antibody trial with NIH; Amgen, AbbVie, Takeda team on a drug
Eli Lilly and the NIH are about to start a first-of-its-kind trial that researchers and developers have talked about for months as a way of providing temporary immunity to the most at-risk populations.
Lilly announced this morning that it will start a 2,400-person trial with the National Institute for Allergy and Infectious Diseases to test whether its experimental Covid-19 neutralizing antibody can prevent people in nursing homes and assisted living facilities from developing the disease. The idea, known as passive immunity, is that rather than waiting on a vaccine to induce people to develop antibodies, doctors can give them lab-grown antibodies. Ideally, those antibodies will either attack the new SARS-CoV-2 infection, if the patient has recently been exposed, or persist in the blood for several weeks and prevent infection or disease for that period.
The approach is considered particularly useful in the elderly, who are both at an elevated risk of dying from Covid-19 and are less likely to respond to a vaccine. Regeneron has launched a similar trial in partnership with NIAID, testing their antibody in people who have likely been exposed as close contacts of Covid-19 patients. Vir has plans to start their own prophylaxis trial this month.
Lilly’s Phase III trial will measure whether a single dose of the antibody, developed with the Vancouver biotech AbCellera and known as LY-COV555, can prevent SARS-CoV-2 infection for 4 weeks and Covid-19 symptoms for 8 weeks.
To conduct the trial, Lilly has retrofitted RVs into “customized mobile research units” that will allow investigators to prepare clinical trial material and infuse patients with the antibody on-site.
Takeda, Amgen, AbbVie team on Covid-19 trial
Takeda, Amgen and AbbVie announced they will team up on a trial to see whether a drug from each company can be repurposed to help treat patients with severe Covid-19.
The trial, known as I-SPY COVID, will test Takeda’s investigational chemokine antagonist Firazyr, Amgen’s blockbuster PDE4 inhibitor Otezla, and AbbVie’s angioedema drug cenicriviroc. The study will use an adaptive trial design to test each of the drugs in combination with the two drugs proven to help Covid-19 patients — the Gilead antiviral remdesivir and the generic steroid dexamethasone — against a combination of just remdesivir and dexamethasone.
The study is one of the first visible results to come out the Covid R&D Alliance, a group formed in April to pool resources and insight from some of the top pharmas and biotechs and prioritize the best therapies. The alliance says it has also screened over 1,900 other preclinical Covid-19 candidates and helped speed the development of novel therapeutics.
Each of the three drugs have different mechanisms of action that could mitigate symptoms in severe Covid-19 patients. Otezla could combat the overactive inflammatory response and Firazyr might limit fluid buildup in lungs. Cenicriviroc, by blocking certain immune signal, might mitigate acute respiratory distress.
Drug repurposing has been tried since Covid-19’s early days, with limited success. IL-6 inhibitors from Regeneron and Roche have failed, as have a series of HIV drugs. The NIH is currently testing Eli Lilly’s JAK inhibitor baricitinib in combination with remdesivir to see if it can improve symptoms in severe patients.
NeuroRx, Relief Therapeutics launch Phase II/III tout report of a single patient
Relief Therapeutics and NeuroRx have launched a Phase II/III trial and expanded access protocol for their vascular peptide aviptadil in patients with Covid-19. The drug had been in development for pulmonary sarcoidosis and pulmonary hypertension before the companies started testing it in Covid-19 patients, with the idea that it could block pro-inflammatory cytokines and protect certain lung cells from infection. The companies have touted the report of a single patient with severe Covid-19 who, given the drug under expanded access, recovered in 4 days. NeuroRx CEO Jonathan Javitt was an author on that pre-print report.
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