July 20, 2021 (Newswire.com) –
Direct Biologics, a market-leading innovator and cGMP producer of regenerative biologic merchandise, introduced at this time that it has obtained FDA approval to provoke a Section I/II trial underneath an Investigational New Drug (IND) protocol for using ExoFlo™ within the therapy of Publish-Acute COVID-19 Syndrome. This trial is Direct Biologics’ second accredited IND, and it represents the primary IND ever accredited by FDA for using extracellular vesicles (EVs) to deal with Publish-Acute COVID-19 syndrome, Continual Publish-COVID-19 syndrome, or any post-viral syndrome.
The Section I/II EIPACS COVID-19 (ExoFlo Infusion Remedy for Post-Acute COVID-19 Syndrome) will start later in 2021. Pronounced “EYE-PACS,” this double-blind, placebo-controlled, randomized scientific trial will consider the therapeutic impact of ExoFlo infusion upon the debilitating set of signs, mostly fatigue and shortness of breath, that severely restrict high quality of life for a big proportion of sufferers for weeks and months after the acute COVID-19 an infection has subsided. The infusions might be administered in an outpatient setting.
In keeping with Mark Adams, Co-Founder and Chief Government Officer, “The approval to proceed with extra scientific trials underneath a brand new IND validates this extraordinary extracellular vesicle product throughout a essential time when 10% to 35% or extra of these contaminated with COVID-19 develop long-hauler syndromes. That’s at the very least 3.3 to 11.55 million instances within the US alone.” He went on to notice “we’ve witnessed unbelievable outcomes that illustrate ExoFlo’s capability to enhance the physique’s regenerative response to the inflammatory destruction attributable to COVID-19. With no reportable opposed occasions in both EXIT COVID-19 Section II or the expanded entry program, we really feel extraordinarily assured that the ultimate evaluation will affirm ExoFlo’s capability to assist sufferers get better from COVID-19 associated ARDS and likewise validate its security profile.”
Vik Sengupta, MD, Chief Medical Officer of Direct Biologics, acknowledged “For long-hauler sufferers severely debilitated by what seems to be a sustained inflammatory and certain autoimmune response that persists lengthy after restoration from acute COVID-19, it seems that ExoFlo has the potential to revive well being and vitality by downregulating persistent irritation, selling revascularization of broken tissues, and reworking scar tissue that may trigger life-long limitations, particularly when these adjustments have an effect on the lungs. To not point out the opportunity of enhancing neurological manifestations together with mind fog, temper dysfunction, and lack of scent and style that seem to even be a big, if not universally current, characteristic of long-hauler syndromes.” Publish-acute COVID-19 sufferers expertise a broad vary of long-lasting signs and different points that preclude them from returning to prior baseline well being and having fun with their each day lives.
“With no accredited therapy for Publish-Acute COVID-19 or Continual Publish-COVID-19 syndromes, there’s a giant unmet public well being want that we consider might be solved by ExoFlo,” acknowledged Direct Biologics’ Co-Founder and President, Joe Schmidt. “As well as, the emergence of recent, deadlier, and extra transmissible SARS-Cov-2 variants, and the worldwide explosion of instances in current months signifies the necessity to carry ExoFlo to the forefront.”
“We want higher therapeutics for these sufferers who do develop into sick, no matter whether or not or not efficient vaccines have been generated,” mentioned Affiliate Chief Medical Officer Sascha Qian Sengupta, MD. “The SARS-Cov-2 variants that possess resistance to vaccines and monoclonal antibody therapies pose the next threat of demise and different issues.”
The Section I/II EIPACS IND approval follows on the heels of the profitable completion of two scientific trials evaluating ExoFlo for the therapy of COVID-19 associated acute respiratory misery syndrome (ARDS) in inpatient and ICU settings underneath Direct Biologics’ first IND: (1) EXIT COVID-19 (ExoFlo Infusion Treatment for COVID-19 Related ARDS), a 102 affected person Section II, multi-center, double-blind, randomized, placebo-controlled trial, and (2) EXIT EAP, a 50 affected person open-label expanded entry protocol by which sufferers too sick to fulfill acceptance standards for the Section II trial, have been handled underneath compassionate-use. These trials function a prelude to the following stage of Direct Biologics’ ongoing effort within the struggle in opposition to the COVID-19 pandemic, which would be the international launch later this yr of each a randomized, placebo-controlled Section III scientific trial and an expanded entry scientific trial.
ExoFlo is an investigational new drug that has not been accredited or licensed by FDA. It’s an allograft extracellular vesicle product remoted from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo supplies signaling proteins which were proven to modulate irritation and should stimulate bioactivity and direct mobile communication.
About Direct Biologics
Direct Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility situated on the College of California, San Diego, and an Operations and Order Success Heart situated in St. Louis, Missouri. Direct Biologics is a market-leading innovator and cGMP producer of regenerative medical merchandise, together with a strong line of extracellular vesicle-based organic merchandise. The Firm was created to develop the science of cutting-edge biologic applied sciences. Direct Biologic’s administration workforce holds intensive collective expertise in biologics analysis, growth, and commercialization, making the Firm a pacesetter within the evolving, subsequent technology phase of the biotherapeutics trade. Direct Biologics is devoted to pursuing extra scientific purposes of ExoFlo by means of the FDA’s investigational new drug utility course of. For extra data go to www.directbiologics.com.
Electronic mail: Data@directbiologics.com
Supply: Direct Biologics