SONOMA, Calif. – Pulthera, LLC has received notice from the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) that it can proceed with “A Phase 2b, Multi-center, Randomized, Double-blinded, Placebo-controlled Study to Assess the Efficacy, Safety, and Tolerability of Intravenous Allogenic Bone Marrow-derived Mesenchymal Stem Cells in Subjects with Dyspnea Associated with Post-acute Sequelae of SARS-CoV-2 Infection.” The study will enroll up to 246 patients into two cohorts, randomized 1:1 to receive the active study drug plus standard treatment or placebo (lactate ringer solution) plus standard treatment, and will use MSCs manufactured by US-based Stemedica Cell Technologies.
Around 23 million people in the U.S. are living with long COVID, which is characterized by symptoms that continue after the initial viral infection for several weeks or more. An estimated 4 million people are unable to work due to the lingering symptoms and effects of long COVID. Because long COVID is such a new phenomenon and it’s not just one condition, it has been very difficult for physicians to effectively treat and manage the post-COVID conditions.
With the help of Rho, Inc., a leading global contract research organization, and protocol chief, Mark Nicolls, MD, who currently serves as Division Chief of Pulmonary, Allergy, and Critical Care Medicine at Stanford University, Pulthera will study the impact of MSCs as a therapeutic to aid those recovering from long COVID.
“Long COVID is a significant health problem that has emerged in the wake of the pandemic. Because long COVID presents in a number of ways that involve symptoms like shortness of breath, brain fog and fatigue, effective therapies are hard to design. MSCs possess broad anti-inflammatory and anti-fibrotic properties that may benefit the underlying condition,” says Nicolls.
The National Institutes of Health (NIH) has received $1 billion from Congress to run the largest research initiative on long COVID in the country, the Researching COVID to Enhance Recovery (RECOVER) initiative. Under the initiative, researchers will study the basic biology underlying long COVID and work on developing possible treatments. Earlier this year, Pulthera submitted a proposal to the NIH to participate in the RECOVER program as it seeks to develop treatments for those suffering from long COVID.
“The pandemic was very disruptive for many months, and we are now having to deal with the long-term impacts of COVID-19. We believe that there are regenerative and anti-inflammatory properties with MSC therapy that will positively impact patients suffering from dyspnea caused by long COVID,” said David Grieve, Founder and Chairman of Pulthera.
With the recent news, Pulthera is working to establish trial sites and clinics across the U.S. where patients can be evaluated and enroll in the clinical trial. Given the broad impact of long COVID, “we expect the study to move quickly and think we will see the positive outcomes MSCs provide to long COVID patients within the next year,” said Grieve.
About Pulthera, LLC
Pulthera, LLC is a US-based biopharmaceutical company focusing on the commercialization of “off the shelf” stem cell therapeutics designed to more effectively treat long COVID and potentially provide a strong defense against future pandemics. The Company has licensed the exclusive right to use, sell and distribute proprietary adult mesenchymal stem cells for all COVID-related and respiratory indications worldwide (some exclusions apply). Visit www.pulthera.com for more information about the Company.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of progenitor cell, protein, and combination therapeutics for underserved medical conditions. Stemedica has developed a proprietary manufacturing technology platform that produces allogeneic progenitor cell products with intellectual property protection under a low-oxygen, low-tension environment in a cGMP-compliant manufacturing facility. The company’s lead drug candidate, ischemia-tolerant mesenchymal stem cells, or itMSCs, is an allogeneic progenitor cell therapy currently in clinical development for the treatment of ischemic stroke, COVID-19 and Alzheimer’s disease. The company’s second drug candidate, ischemia-tolerant neural progenitor cells, or itNSCs, is an allogeneic cell therapy currently in development for spinal cord injury. More information on Stemedica may be found at www.stemedica.com.