Camostat Mesilate

Pfizer, Sagent Pharmaceuticals and Merck are preparing their antiviral pills against SARS-CoV-2 and are showing promise in new clinical trials. Antiviral pills against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel coronavirus responsible for coronavirus disease 2019 (COVID-19), are showing promise in new clinical trials. Scientists across the globe are suggesting SARS-CoV-2 will turn into a seasonal virus once the pandemic has officially come to an end. Cases of COVID-19 have drastically decreased nationwide, thanks largely to authorized vaccines from Pfizer - BioNTech , Moderna , and Johnson & Johnson . But even while states ease pandemic-related restrictions such as mask mandates and social distancing, scientists are quickly working to develop an antiviral pill that can be used each season SARS-CoV-2 comes back around. Up to three of these pills have shown promise in clinical trials. The best early therapies for COVID-19 currently consist of laboratory-produced antibodies. However, these monoclonal antibodies can be costly, and the administration of these therapies is sometimes difficult. For instance, these treatments require infusion into the patient’s blood, which can take time, more staff and greater clinic space. Three new antiviral agents, however, may offer a solution to monoclonal antibody therapies. These three experimental antivirals have been designed to be given in the early stages of developing COVID-19 symptoms and prior to hospitalization. Each pill contains molecules to interfere with coronavirus replication. Pfizer, the maker of one of the first authorized COVID-19 vaccines, has a potential anti-SARS-CoV-2 pill currently in early-stage trials. Pfizer launched its Phase I trial of the novel oral antiviral agent back in late March . Researchers are looking to determine the safety and optimal dose of the pill, dubbed PF-07321332, in a 60-person Phase I trial. “We have designed PF-07321332 as a potential oral therapy that could be prescribed at the first sign of infection, without requiring that patients are hospitalized or in critical care,” said Pfizer’s Chief Scientific Officer and President of Worldwide Research, Development and Medical, Mikael Dolsten, MD, PhD., in a statement. “At the same time, Pfizer’s intravenous antiviral candidate is a potential novel treatment option for hospitalized patients. Together, the two have the potential to create an end to end treatment paradigm that complements vaccination in cases where disease still occurs.” Sagent Pharmaceuticals is also looking into camostat, a drug authorized in Japan in the 1980s for pancreatitis. Currently, camostat isn’t approved in the U.S., but scientists are holding out hope that it can provide robust and durable antiviral activity against the novel coronavirus. The drug has just completed Phase II testing. In this research phase, investigators are now examining data on the drug’s effectiveness and safety in hundreds of volunteers. Both PF-07321332 and camostat are currently being evaluated in the National Institutes of Health’s ACTIV-2 trials. Camostat entered into the trials back in February . Two monoclonal antibodies from Brii Biosciences, BRII-196, and BRII-198, also recently advanced to Phase III in the ACTIV-2 trial. These antibodies are being testing for efficacy and safety in ambulatory patients with COVID-19. Merck and Ridgeback Biotherapeutics’ molnupiravir, an investigational antiviral drug not involved in the ACTIV-2 trial, is another antiviral hopeful currently in Phase III testing. The drug was originally produced for SARS Co-V1 and MERS, making it one potential anti-SARS-CoV-2 drug that’s further along in research. The drug is undergoing efficacy and safety testing in a 1,500-person, late-stage trial.

Transmission electron micrograph of a SARS-CoV-2 virus particle isolated from a patient. Credit: NIAID. The National Institutes of Health (NIH) has commenced subject enrolment in a Phase II/III ACTIV-2 trial of a new fully human polyclonal antibody therapeutic called SAB-185 for treating Covid-19 in non-hospitalised individuals with mild or moderate disease. Developed by SAB Biotherapeutics, SAB-185 has shown to neutralise live SARS-CoV-2 at titers higher than convalescent plasma in pre-clinical studies. Funded by the NIH unit National Institute of Allergy and Infectious Diseases, ACTIV-2 is a master protocol to assess various investigational agents in people with mild-to-moderate Covid-19 who do not require hospitalisation. The ACTIV-2 study design aids scientists in analysing SAB-185 in a small subject group and then progress it to a larger group on finding that the antibody is safe and effective. In the trial, participants will randomly be given either intravenous SAB-185 or another therapeutic or a placebo. Other therapeutics being analysed in the trial are Brii Biosciences’ experimental antibodies, BRII-196 and BRII-198, Synairgen’s SNG001, AstraZeneca’s AZD7442, and Sagent Pharmaceuticals’ Camostat mesilate. The blinded Phase II study will enrol 110 subjects with mild or moderate Covid-19 and are at risk for disease progression. On finding no serious safety concerns and with promising results from the Phase II study, the trial will progress to Phase III. The Phase III study intends to enrol 421 additional subjects who will be given SAB-185, while another 421 will receive a placebo. Its primary objective is to analyse whether SAB therapy can prevent either hospitalisation or death by 28 days on enrolment. SAB Biotherapeutics co-founder, president and CEO Eddie Sullivan said: “As the Covid-19 pandemic continues to have an impact globally, we are committed to working collaboratively with our government to overcome this health crisis. “Our team is excited to be advancing SAB-185, a potent fully-human polyclonal antibody therapeutic, that offers a highly-differentiated potential treatment for patients.” NIH announced plans to fund the Phase III ACTIV-6 clinical trial to analyse various prescription and over-the-counter medications that are currently available for self-administration to treat Covid-19 symptoms.