Tonix Pharmaceuticals Holdings Corp (NASDAQ: TNXP) stock dropped 6.56% after the company announced plans to develop TNX-102 SL as a possible Long COVID Syndrome treatment. Long COVID is known as the Post-Acute Sequelae of COVID-19.
Tonix to meet FDA in Q3 to discuss TNX-102 SL in Long COVID treatment
The company will meet the US FDA in Q3 2021 to agree on the potential second phase pivotal study design and overall TNX-102 SL clinical development plan for eligibility of the drug as a Long COVID-19 treatment.
Despite most patients recovering from COVID-19 within weeksof sickness, a significant number of them acquire a chronic syndrome known as Long COVID. These people show a slew of symptoms that last long after they’ve recovered. Interestingly, the SARS-CoV-2 virus appears to have been eliminated in mostLong COVID patients investigated. Sleep difficulties, fatigue, pain, shortness of breath, fevers, cognitive impairment (often known as “brain fog”), anxiety, gastrointestinal issues, and depression are some of Long COVID’s symptoms.
Long COVID can last for months and can be minor to incapacitating in severity. The persistence of symptoms after SARS-CoV-2 infection has been observed in more than 30% of patients across many cohort studies. Sometimes Long COVID can develop after asymptomatic SARS-CoV-2 infection or mild COVID-19, albeit it is most commonly linked with moderate to severe COVID-19.
Long COVID has similar symptoms as fibromyalgia.
Tonix CEO Seth Lederman said they are delighted to commence TNX-102 SL development for Long COVID treatment. The program exploits what the Tonix team has learned regarding TNX-102 SL’s pharmacodynamic activity in over 1,000 patients enrolled in the fibromyalgia studies to date. Lederman said that Long COVID is similar to fibromyalgia because symptoms manifested in both include persistent pain, brain fog, fatigue, and sleep disturbance. He said that Long COVID is an acute disabling condition that will lead to a considerable global economic burden.