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January 25, 2022

Long Covid-19: drug trial results to watch in 2022

At least four long Covid-19 drug trial readouts are expected in 2022 that could shape the future of the therapeutic space.

By William Newton

Long Covid-19 can leave patients with lingering cognitive, respiratory, and functional symptoms months after a SARS-CoV-2 infection. As the pandemic enters its third calendar year, at least four major drug trial readouts in 2022 could shed light on the future of long Covid-19 drug development.

Axcella Health, PureTech, MGC Pharma, and 9 Meters Biopharma each have Phase II readouts expected this year for long Covid-19, or post-acute sequelae of SARS-COV-2 infection (PASC). Each asset targets a different class of long Covid-19 symptoms, ranging from exertional fatigue to breathing complications. At least six more long Covid-19 trials have expected completions dates in 2022, though no established timelines for results.

“Just as there is no single thing that causes people to develop long Covid-19, there likely won’t be a single solution that alleviates long Covid-19 symptoms,” notes James Jackson, a long Covid-19 researcher at Vanderbilt University. This means long Covid-19 will likely require a multi-pronged solution, he adds.

Long Covid-19 trial challenges

The need for long Covid-19 therapies loom large. As many as 57% of Covid-19 survivors have at least one symptom of long Covid-19, according to a study based on electronic health records. In fact, more than one in three Covid-19 survivors had at least one long Covid-19 feature three-to-six months after their acute infection.

Despite the prevalence of long Covid-19, there is still a stigma surrounding its cognitive symptoms, Jackson explains. Hesitancy to report symptoms – and wider scepticism toward the medical community – can pose obstacles to recruiting for trials, he adds.

In addition, the endpoints for long Covid-19 trials have less clearly delineated outcomes than drug trials for acute infections that often use reduction in hospitalisations and deaths. Clinicians often lack universal definitions of long Covid-19 causes and symptoms, making it tough to agree on measures of improvement, Jackson explains.

Overall, the drug development industry in 2022 is set to run more trials for Covid-19 therapeutic drugs than for preventive vaccines. Some 65% of planned Covid-19 trials for 2022 are for therapeutics, compared to 35% for vaccines, according to a GlobalData report. Most therapeutic drug trials in Covid-19 are in Phase II (47.1%), followed by Phase I (29.4%).

PureTech targets post-acute respiratory disease

PureTech anticipates topline Phase II results for LYT-100 in the first half of 2022 for long-term respiratory complications stemming from a prior hospitalisation due to Covid-19. The Phase II study (NCT04652518) is enrolling 168 patients who previously received ventilation or other means of oxygen administration while hospitalised for Covid-19 but have since been on no oxygen or low-dose oxygen.

For its primary endpoint, the placebo-controlled trial measures change over 91 days in the six-minute walk test (6MWT), a validated endpoint assessing distance covered during six minutes of walking. Secondary endpoints include patient-reported outcomes, inflammatory biomarkers, and pharmacokinetics.

LYT-100 is a deuterated form of pirfenidone, which received FDA-approval in 2014 under the brand name Esbriet as a treatment for idiopathic pulmonary fibrosis. PureTech’s formulation could have an attenuating metabolisation rate, reducing the likelihood of gastrointestinal tolerability issues that have arisen with Esbriet. In a previous Phase I trial, all LYT-100 doses were well-tolerated, with only mild treatment-emergent adverse events reported.

Axcella takes aim at post-Covid-19 fatigue

Axcella Health expects topline Phase IIa results in mid-2022 for its trial of AXZ1125 targeting fatigue-predominant long Covid-19. The 40-patient trial (NCT05152849) is enrolling subjects who have had a documented Covid-19 at least 12 weeks prior to screening and have exertional fatigue unexplainable by other causes.

As a primary endpoint, the placebo-controlled trial measures four-week change in the phosphocreatine (PCr) recovery rate following moderate exercise. PCr recovery rate is a measure of mitochondrial function, which has previously been an endpoint in fatigue-related conditions such as primary pulmonary hypertension. Key secondary endpoints include the six-minute walk test, fatigue scores, and safety and tolerability.

AXA1125 is a mixture of amino acids that can increase fatty acid oxidation, ATP production, ketogenesis, and mitochondrial bioenergetics — leading to improved muscle function. In addition, Axcella is studying AXA1125 in the Phase IIb EMMPACT trial (NCT04880187) in nonalcoholic steatohepatitis (NASH).

Mass Gen studies long Covid-19 in children

The Massachusetts General Hospital is investigating 9 Meters Biopharma’s AT1001 (larazotide acetate) for multisystem inflammatory syndrome in children (MIS-C) related to Covid-19. MIS-C symptoms appear an average of four weeks after a Covid-19 infection, and the condition can lead to serious inflammation that damages organs. Results for the Phase IIa trial (NCT05022303) are expected to read-out in 2022.

The 20-participant, placebo-controlled study is evaluating the efficacy and safety of AT1001 on “mitigating symptoms of MIS-C” over 24 weeks, though the trial page does not specify by what measure. AT1001 reduces autoimmune responses by binding to the zonulin receptor.

MGC Pharma tackles functionality

MGC Pharma’s ArtemiC Support is in a 150-patient study for long Covid-19 functionality, with an expected completion of February 2022 and results in the second quarter of 2022. Though there is no publicly available trial registry, the company says it will test efficacy through the Post-Covid-19 Functional Scale (PCFS) one, two, three, and six weeks after treatment initiation.

As a physician-supervised survey, PCFS assesses seven symptom areas: dyspnea, cough, asthenia, anosmia, ageusia, headache, and mental confusion. ArtemiC Support is comprised of Boswellia serrata, Curcuma longa, and Vitamin C, though its mechanism has not been detailed.

Long Covid-19 2022 Trial Results Calendar

EventCompanyDrugMechanismLong Covid-19 Symptom
Phase II topline results mid-2022Axcella HealthAXA-1125Amino acid mixture that increases fatty acid oxidation, ATP production, ketogenesis, and mitochondrial bioenergeticsExertional fatigue
Phase II topline results H1 2022PureTechLYT-100Deuterated form of pirfenidone; mechanism to be detailedRespiratory complications
Phase II results Q2 2022MGC PharmaArtemiCBoswellia serrata, curcuma longa, and Vitamin C; mechanism to be detailedFunctionality
Phase II results 20229 Meters BiopharmaAT1001CD163 antagonist that binds to zonulin receptors to reduce autoimmune responseMultisystem inflammatory syndrome in children (MISC)

Long Covid-19 2022 Trial Completion Calendar

EventCompanyDrugMechanismLong Covid-19 Symptom
Phase II completion January 2022RochePirfenidoneImmunosuppressant that inhibits collagen synthesis, down regulates cytokine production, and blocks fibroblast proliferationPulmonary fibrosis
Phase II completion March 2022AgelessRxLow-dose naltrexon (LDN) and nicotinamide adenine dinucleotide (NAD+)LDN is an opioid receptor antagonist; NAD+ is an oxidizing agent. Designed to have anti-inflammatory and neuroprotective effectsFatigue
Phase II completion Q2 2022Resolve TherapeuticsRSLV-132Human biologic Fc fusion protein that prevents activation of the immune system via Toll-like receptors and the interferon pathwayFatigue and brain fog
Phase II completion April 2022Sorrento TherapeuticsPSC-04Cell therapy that inhibits the inflammatory response, reduce damage of alveolar epithelial cells and endothelial cells, and repair lung functionPulmonary symptoms
Phase II completion June 2022Brain and Cognition Discovery FoundationVortioxetineSelective serotonin reuptake inhibitor and serotonin receptor modulator. Enhances levels of serotonin, noradrenaline, dopamine, acetylcholine, and histamineCognitive defects
Phase II completion September 2022Bod AustraliaMediCabilisMedical cannabis that downregulates stress-related signals involved in chronic inflammation and painLong Covid-19; to be detailed

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