Over a dozen well-known OINDP specialists have issued a call for accelerated development of inhaled therapies for COVID-19, with the goal of getting these products to patients faster. Writing to the editor of the Journal of Aerosol Medicine and Pulmonary Drug Delivery, members of the Regulatory and Standardization Issues Networking Group of the International Society for Aerosols in Medicine (ISAM) issue an “urgent appeal” to prioritize development of OINDPs for all stages of SARS-CoV-2 infection, from prophylaxis to severe disease.
The group states, “We believe that it is important from the outset to take a highly collaborative approach between stakeholders (regulators and inhalation drug developers initially, supported by studies at the earliest opportunity involving patients and their caregivers) to share our collective knowledge to deliver therapies that have a high probability of having a favorable benefit/risk ratio in the target population.”
The majority of therapies in development for COVID-19 are delivered via injection, the letter says, despite the fact that “the location of initial infection (i.e., upper respiratory tract and central airways through direct surface contact or deposition of inhaled droplets) and the route of disease progression after initial infection are primarily through the respiratory system” and the possibility of minimizing side effects from systemic exposure by respiratory delivery.
According to the letter, regulators should consider several modified approaches to clinical trial data in studies of inhaled drugs for COVID-19, including:
- Reducing the number of subjects required for trials of “last resort” drugs
- Broadening quality control criteria for therapies “wherein the intended dose has been shown to operate at the plateau of the dose–response curve with good safety”
- Accelerating Phase 1a studies to get to Phase 1b trials faster by utilizing “existing and/or in silico physiologically based pharmacokinetic modeling data”
- Minimizing the use of placebo controls, particularly by creating “a global anonymized registry of all COVID-19 patients including placebo groups to be able to rapidly analyze the active groups in trials against each other, as well as the active groups against the large placebo groups”
“Furthermore,” they say, “we hope that the exploration of the new paths to manage the SARS-CoV-2 health care risks and the experience gained will provide an expeditious path for development of new inhaled medications delivery for any future respiratory pathogen challenges as well.”
Read the ISAM working group letter to the editor.
