25 Jun 2020
Posted in Pharma
Gilead’s inhaled remdesivir to commence Phase I trials, but new formulation may be required, says GlobalData
Following Gilead’s announcement that it will begin Phase I clinical trials for inhaled remdesivir in healthy volunteers, data and analytics company GlobalData anticipates that a new route of administration will specifically target patients with mild to moderate COVID-19 infection and will be administered via a nebuliser so that patients can self-administer away from hospital. GlobalData believes that Gilead will successfully develop a formulation that will be nebulised, however, there may be difficulties in implementing widespread use in the home setting.
Angad Lotay MPharm, Infectious Diseases Analyst at GlobalData, states: “Remdesivir has proven anti-viral activity as a viral RNA polymerase inhibitor. This is highly relevant in the context of COVID-19 because in the early stages of disease the virus is the major driver, whereas in severe patients in later stages it appears to be our own immune system overreacting. Although Gilead has been testing remdesivir with immune modulators to tackle the enormous immune reactions that strike patients in the later stage of illness, at least 80% of symptomatic cases are mild to moderate. It is, therefore, no surprise that Gilead is leaning on the success of remdesivir to target this population.”
An inhaled formulation administered via nebulizer may allow for easier administration outside the hospital setting, but Gilead may need to reformulate its powdered remdesivir vial to achieve this, as it currently requires reconstitution prior to intravenous administration. Furthermore, the supplying of equipment and nebulizers to each patient will be a large cost barrier.
Lotay continues: “Although there are chronic conditions that permit training to reconstitute medication for self-administration by injection or nebuliser, it is uncommon to see this in acute infections without the assistance of trained staff. Supplying equipment to each patient would certainly raise concerns regarding costs and supply, which would bare a significant barrier.”
From analysing clinical trial data, GlobalData expects that, as with other treatment options, the decision of when to start treatment will be key. However, at this stage of development, safety and efficacy are the primary concerns. In clinical trials to date, patients receiving IV remdesivir had a 31% faster recovery time, but the majority of patients with mild COVID-19 usually recover at home, with supportive care and isolation in accordance with guidelines. Therefore, it will be a test for Gilead to demonstrate the significance of inhaled therapy and how far it outweighs the current standard of care.