Therapeutics for ‘COVID-19 Long-Haulers’ Exploding onto the Scene as 2020 Ends

2020 Ending

It’s almost 2021, and the whole world just wants to move on from COVID-19. This is proving very difficult, however, for the ever-expanding group of people dealing with the chronic and debilitating symptoms of what is commonly being called “Long Haul COVID” or “Long COVID.”

While the overall understanding of the condition is as novel as the virus that causes it, a recent survey from the U.K.’s Office for National Statistics stated that at least 10% of COVID-19 sufferers experience symptoms lasting for three months or longer.

The struggle is real, and BioSpace spoke with just a couple of companies endeavoring to make 2021 a happier new year for survivors now suffering from the life-altering after-effects of COVID-19.

PureTech Health Plc., a clinical-stage biotherapeutics company nestled in the Cambridge-Boston biotech hub, is leveraging its unique understanding of the Brain-Immune-Gut axis to develop novel therapeutics for a wide range of devastating conditions – including, most recently, Long COVID.

On December 3, the PureTech initiated a global, Phase II trial of LYT-100 (deupirfenidone) in Long COVID respiratory complications and related sequelae. The trial is ongoing in the U.S. and Europe, and PureTech Head of Innovation, Dr. Michael C. Chen, told BioSpace that the company expects results in the second half of 2021.

LYT-100 is an anti-fibrotic and anti-inflammatory oral small molecule that has been designed to overcome the tolerability challenges associated with pirfenidone, an anti-inflammatory, anti-fibrotic drug currently on the market.  Chen explained that has the potential to treat inflammation and fibrosis associated with a range of respiratory conditions, including those associated with Long COVID.

“We believe that the respiratory complications of Long COVID are being driven by residual inflammation and fibrosis, or scarring, in the lungs. So we believe that the dual mechanism, anti-inflammatory and anti-fibrotic, is ideally suited to address the issues in long COVID respiratory complications,” he said. “We see this as a major unmet need, and that includes respiratory complications component of long COVID. So far, these respiratory complications are among the most common symptoms or problems that Long COVID, long-haulers are experiencing.”

Organicell Regenerative Medicine, Inc., a Miami, Florida-based clinical-stage biopharmaceutical company focused on harnessing the power of nanoparticles for the treatment of degenerative diseases, is awaiting a decision from the FDA regarding an investigational new drug (IND) application for a clinical trial of its proprietary therapeutic, Zofin, in COVID Long-haulers. 

Zofin is an acellular biologic therapeutic derived from perinatal sources, consisting of 300 growth factors, cytokines and chemokines, along with other extracellular vesicles/nanoparticles derived from perinatal tissues.

In September, Organicell kicked off a placebo-controlled, randomized multi-center Phase I/II trial to investigate Zofin as a potential treatment for moderate to severe acute respiratory syndrome (SARS) related to current COVID-19 infections. Concurrently, the company has also treated four long-hauler patients under emergency INDs.

Organicell Chief Science Officer Dr. Mari Mitrani described the case of one of these patients, a previously healthy surgeon and marathon runner who had been hospitalized, in and out of the ICU, for seven weeks with COVID-19. He was treated with three doses of Zofin, which is the standard regimen. 

“Between the second and the third infusion, he already saw changes in his shortness of breath, fatigue, and muscle aches that he was experiencing, and he was ready to go back to work after 3-4 weeks. He went from totally debilitated to going back to the OR,” Mitrani said. “We understand that this is a single case. We have done 4 of those single cases and have seen the same results, where patients go back to having less shortness of breath, less muscle aches, less fatigue. That is what drove us to actually file for an IND.”

Mitrani explained that these cases “let us understand a little bit more of the dynamic of what the composition of our product can do for these types of patients. It’s been very eye-opening on how our drug that has…the ability to target either the lung problems or the multi-organ problems that we are seeing with long-haulers.” 

On the left coast, Vancouver, Washington-based biotech, CytoDyn Inc., recently applied to the FDA for permission to test its experimental drug, Vyrologix™ (leronlimab), a monoclonal antibody, on 102 COVID-19 long-haulers, the company’s chief medical officer, Scott A. Kelly told the Wall Street Journal.

On Tuesday, CytoDyn announced that a treating physician had received authorization from the FDA to administer leronlimab to a COVID-19 patient under an emergency IND (eIND).

 “We are very thankful the FDA is allowing severe-to-critical COVID-19 patients access to Vyrologix™ (leronlimab) again under eIND while we await the unblinding of data from our recently completed Phase III registrational trial. We are receiving daily requests from families seeking our drug for a loved one with COVID-19,” CytoDyn President and Chief Executive Officer Nader Pourhassan Ph.D.  said in a statement.

Leronlimab, which is a viral-entry inhibitor against the CCR5 receptor, is originally intended as an HIV drug, though it has yet to receive FDA approval in this disease area. The regulator has, however, granted the experimental drug Fast Track designation for leronlimab in two potential indications, for HIV-infected patients in combination with HAART, and metastatic triple-negative breast cancer.

Leronlimab is currently undergoing a Phase IIb/III trial to evaluate its efficacy and safety for patients with severe-to-critical COVID-19.

While Organicell and Cytodyn wait to hear back on their clinical trials and PureTech awaits the results of its Phase II study, Chen stated that this treatment area is ripe with need. 

“We feel like the vast majority of treatments in development for COVID have really focused on the acute part of COVID,” said Chen. “But given the scale, and I think the public health impact, of long COVID, this means that there will be potentially a very immense public health need in the future.”

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