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Classified in: Health, Covid-19 virus
Subjects: TRI, FDA

Resolve Therapeutics Receives FDA Approval to Initiate Phase 2 Clinical Trial of RSLV-132 in Long Covid Patients

ST. PETERSBURG, Fla., June 23, 2021 /PRNewswire/ -- Resolve Therapeutics, pioneering first-in-class, targeted, safe therapies for underserved autoimmune diseases, today announced that the US Food and Drug Administration has approved a New Investigational Drug application for RSLV-132 to initiate a phase 2 clinical trial in patients with long covid.

It is estimated that up to 30% of patients infected with SARS-CoV-2, the virus that causes COVID-19, have ongoing, debilitating symptoms lasting several months up to one year following the acute phase of the infection. The most common symptom by far is severe, debilitating fatigue. In addition, some patients appear to have an autoimmune component to their infection as several studies have observed the development of various autoantibodies following infection. Recent studies suggest that viral RNA and RNA-containing autoantibodies in the CNS of patients with long covid may be causing inflammation resulting in fatigue and brain fog. "Based on our previous positive phase 2 clinical trial with RSLV-132 in autoimmune fatigue, we are hopeful that removing circulating RNA in long covid patients will have a similar improvement in their fatigue and brain fog," said Dr. James Posada, chief executive officer of Resolve Therapeutics.

About RSLV-132

RSLV-132 is a safe, novel, targeted biologic drug designed to remove pro-inflammatory nucleic acids from the circulation of patients, which is one of the key triggers of multiple pro-inflammatory cascades. The compound consists of a catalytically active human RNase moiety fused to a human IgG1 Fc domain that digests RNA circulating in the blood and thereby decreases inflammation.

About Resolve Therapeutics

Resolve Therapeutics is pioneering safe, targeted therapies for underserved autoimmune diseases with large unmet medical needs. The Company's lead compound, RSLV-132, is a first-in-class investigational treatment in development for lupus and Sjogren's syndrome. The drug eliminates the inflammatory material found in the blood of patients with autoimmune diseases, thereby preventing the activation of numerous pro-inflammatory cascades. RSLV-132 removes just the inflammatory stimulating molecules, without shutting down the immune system or interfering with key steps in the innate immune system. For more information, visit http://resolvetherapeutics.com/.

James Posada
Resolve Therapeutics

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SOURCE Resolve Therapeutics

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