Direct Biologics Announces FDA Approval for Proceeding With Second ExoFlo IND for Post-Acute COVID-19 Syndrome and Chronic Post-COVID-19 Syndrome

Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that it has received FDA approval to initiate a Phase I/II trial under an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment of Post-Acute COVID-19 Syndrome. This trial is Direct Biologics' second approved IND, and it represents the first IND ever approved by FDA for the use of extracellular vesicles (EVs) to treat Post-Acute COVID-19 syndrome, Chronic Post-COVID-19 syndrome, or any post-viral syndrome.

The Phase I/II EIPACS COVID-19 (ExoFlo Infusion Treatment for Post-Acute COVID-19 Syndrome) will commence later in 2021. Pronounced "EYE-PACS," this double-blind, placebo-controlled, randomized clinical trial will evaluate the therapeutic effect of ExoFlo infusion upon the debilitating set of symptoms, most commonly fatigue and shortness of breath, that severely limit quality of life for a large proportion of patients for weeks and months after the acute COVID-19 infection has subsided. The infusions will be administered in an outpatient setting.

According to Mark Adams, Co-Founder and Chief Executive Officer, "The approval to proceed with additional clinical trials under a new IND validates this extraordinary extracellular vesicle product during a critical time when 10% to 35% or more of those infected with COVID-19 develop long-hauler syndromes. That is at least 3.3 to 11.55 million cases in the US alone." He went on to note "we have witnessed incredible results that illustrate ExoFlo's ability to augment the body's regenerative response to the inflammatory destruction caused by COVID-19. With no reportable adverse events in either EXIT COVID-19 Phase II or the expanded access program, we feel extremely confident that the final analysis will confirm ExoFlo's ability to help patients recover from COVID-19 related ARDS and also validate its safety profile."

Vik Sengupta, MD, Chief Medical Officer of Direct Biologics, stated "For long-hauler patients severely debilitated by what appears to be a sustained inflammatory and likely autoimmune response that persists long after recovery from acute COVID-19, it appears that ExoFlo has the potential to restore health and vitality by downregulating persistent inflammation, promoting revascularization of damaged tissues, and remodeling scar tissue that can cause life-long limitations, especially when these changes affect the lungs. Not to mention the possibility of improving neurological manifestations including brain fog, mood disorder, and loss of smell and taste that appear to also be a significant, if not universally present, feature of long-hauler syndromes." Post-acute COVID-19 patients experience a broad range of long-lasting symptoms and other issues that preclude them from returning to prior baseline health and enjoying their daily lives.

"With no approved treatment for Post-Acute COVID-19 or Chronic Post-COVID-19 syndromes, there is a large unmet public health need that we believe can be solved by ExoFlo," stated Direct Biologics' Co-Founder and President, Joe Schmidt. "In addition, the emergence of new, deadlier, and more transmissible SARS-Cov-2 variants, and the international explosion of cases in recent months indicates the need to bring ExoFlo to the forefront." 

"We need better therapeutics for those patients who do become sick, regardless of whether or not effective vaccines have been generated," said Associate Chief Medical Officer Sascha Qian Sengupta, MD. "The SARS-Cov-2 variants that possess resistance to vaccines and monoclonal antibody therapies pose a higher risk of death and other complications." 

The Phase I/II EIPACS IND approval follows on the heels of the successful completion of two clinical trials evaluating ExoFlo for the treatment of COVID-19 related acute respiratory distress syndrome  (ARDS) in inpatient and ICU settings under Direct Biologics' first IND: (1) EXIT COVID-19 (ExoFlo Infusion Treatment for COVID-19 Associated ARDS), a 102 patient Phase II, multi-center, double-blind, randomized, placebo-controlled trial, and (2) EXIT EAP, a 50 patient open-label expanded access protocol in which patients too ill to meet acceptance criteria for the Phase II trial, were treated under compassionate-use. These trials serve as a prelude to the next stage of Direct Biologics' ongoing effort in the fight against the COVID-19 pandemic, which will be the global launch later this year of both a randomized, placebo-controlled Phase III clinical trial and an expanded access clinical trial.

About ExoFlo

ExoFlo is an investigational new drug that has not been approved or licensed by FDA. It is an allograft extracellular vesicle product isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo provides signaling proteins that have been shown to modulate inflammation and may stimulate bioactivity and direct cellular communication.

About Direct Biologics

Direct Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility located at the University of California, San Diego, and an Operations and Order Fulfillment Center located in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP manufacturer of regenerative medical products, including a robust line of extracellular vesicle-based biological products. The Company was created to expand the science of cutting-edge biologic technologies. Direct Biologic's management team holds extensive collective experience in biologics research, development, and commercialization, making the Company a leader in the evolving, next generation segment of the biotherapeutics industry. Direct Biologics is dedicated to pursuing additional clinical applications of ExoFlo through the FDA's investigational new drug application process.