Covid-19 R&D: what else besides vaccines?
While Pfizer/BioNTech's Covid-19 vaccine candidate gained emergency use authorization in the UK on December 2, making it the first in Europe to get the green light, what happened in the rest of the pharma-industry? Many things for sure, as all companies are not exclusively working on vaccines.
So far, the FDA has officially greenlighted Gilead Sciences' antiviral Veklury (remdesivir) to treat hospitalized Covid patients. However, the WHO on November 20 issued a conditional recommendation against the administration of remdesivir to hospitalized patients, regardless of the severity of their symptoms, as there is no evidence to date that remdesivir improves the outcomes for these patients. chances of survival and other health outcomes.
In November, it also granted Eli Lilly's arthritis med Olumiant an emergency use authorization to be used alongside the Gilead drug in patients who need oxygen support.
Two additional products were also granted authorization: Lilly's AbCellera and Regeneron's antibody cocktail of casirivimab and imdevimab. The AbCellera-partnered therapy, also known as LY-CoV555, was authorised to treat recently diagnosed, mild-to-moderate Covid-19 in patients 12 years and older with a positive Covid-19 test, who are at high risk for progressing to severe disease and/or hospitalisation.
In the case of Regeneron, the monoclonal antibodies, also referred to as REGN-COV2 or as REGEN-COV2 when used in combination, are directed against the spike protein of SARS-CoV-2. However, the FDA said the "most important evidence" that the dual antibody therapy may be effective came from the secondary goal of medically attended visits related to Covid-19, particularly hospitalisations and emergency room visits within 28 days after treatment. For patients at high risk for disease progression, results showed that hospitalisations and emergency room visits occurred in 3% of patients treated with casirivimab and imdevimab together, compared to 9% for placebo.
End of November, Amgen, Takeda and UCB launched a global trial to identify whether any of three different drugs can reduce the severity of Covid-19 in hospitalized patients by moderating the immune system's response to the disease. The study will test whether Amgen's psoriasis drug Otezla, Takeda's experimental anti-inflammatory lanadelumab, and UCB's experimental immune system-inhibitor zilucoplan, can prevent the body's own defenses from overreacting to the coronavirus, which can lead to serious tissue and organ damage. "By enrolling both hospitalized intensive care unit and non-intensive care unit patients, the trial seeks to yield greater understanding of how therapeutic interventions may be used with hospitalized Covid-19 patients experiencing a range of symptoms," the companies said.
Still in the fields of Covid-19 treatments, end of November, Merck & Co. acquired all outstanding shares of OncoImmune for an upfront payment of $425 million in cash. Merck will gain its therapeutic candidate CD24Fc, a recombinant fusion protein targeting the innate immune system, as a potential treatment for patients with severe and critical Covid-19. OncoImmune recently reported an interim analysis of CD24Fc on data from 203 hospitalised Covid-19 patients randomised in the Phase III SAC-Covid study. The trial involved patients who need oxygen support, including those on supplemental oxygen, high-flow oxygen and mechanical ventilation. Findings reported in September showed that patients treated with standard care plus a single dose of CD24Fc were 60% more likely to see improvement in their clinical status, compared to placebo and standard of care, with the median time to recovery being six days and 10 days, respectively.