The U.S. Department of Health and Human Services (HHS) recently announced two major initiatives to shed light on long COVID, a condition affecting millions. First, the agency plans to establish the Office of Long COVID Research and Practice. HHS is also set to launch new long COVID-19 clinical trials through its RECOVER initiative. Jointly, the long COVID drug development efforts highlight the need for therapies and create openings for pharmaceutical companies to drive research and drug development related to the condition.
HHS has earmarked $1.15 billion for the RECOVER Initiative to explore novel therapies for the condition estimated to have affected between 7.7 and 23 million Americans. To date, the RECOVER Initiative has enrolled more than 24,000 participants in observational studies on long COVID. New clinical trials, beginning enrollment in summer 2023, will test experimental therapies across five focus areas to identify therapies that can alleviate symptoms and improve quality of life for long COVID patients.
Varied symptoms in long COVID
Long COVID manifests as persistent symptoms after acute COVID-19 infection. Roughly one out of five people who have contracted COVID-19 have had long-COVID symptoms, according to research from CDC. The agency defines the condition, which has symptoms varying from brain fog to shortness of breath, as lasting at least three months after infection.
Developing treatments remains a challenge given the significant variety in long COVID symptoms and patient presentations.
Long COVID drug development initiative from Virios Therapeutics
Pfizer’s Paxlovid, which pharmacists can prescribe, appears to help address long COVID symptoms in some patients, but treating the condition is not an official indication of the drug. A growing number of firms are exploring potential long COVID therapies, like Bateman Horne Center’s trial of Virios Therapeutics’ IMC-1. The research from the biotech Virios is among the most mature to date in the area. The company announced positive data showing improvement in multiple long-COVID symptoms after treatment with a combination of valacyclovir and celecoxib (Val/Cel) in an exploratory, open-label, proof of concept study. Valacyclovir is an antiviral drug while celecoxib is a nonsteroidal anti-inflammatory drug (NSAID).
Female patients diagnosed with long COVID who received the so-called Val/Cel cocktail demonstrated clinically and statistically significant improvements in fatigue, pain and symptoms of autonomic dysfunction and general well-being related to long COVID when treated open-label with Val/Cel for 14 weeks. Virios plans to meet with the FDA in the second half of 2023 to discuss a potential investigational new drug application for a fixed dose combination of the two drugs, aimed at treating symptoms associated with PASC.