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

Press Release
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current: Jul 20, 2021 13:07 CDT

AUSTIN, Texas,
July 20, 2021(Newswire.com) –

Immediate Biologics, a market-top innovator and cGMP manufacturer of regenerative biologic products and solutions, declared currently that it has acquired Fda approval to initiate a Period I/II trial less than an Investigational New Drug (IND) protocol for the use of ExoFlo™ in the treatment method of Post-Acute COVID-19 Syndrome. This trial is Direct Biologics’ second authorized IND, and it signifies the very first IND at any time approved by Fda for the use of extracellular vesicles (EVs) to deal with Write-up-Acute COVID-19 syndrome, Chronic Post-COVID-19 syndrome, or any publish-viral syndrome.

The Period I/II EIPACS COVID-19 (ExoFlo Infusion Remedy for Post-Alovable COVID-19 Syndrome) will begin later on in 2021. Pronounced “EYE-PACS,” this double-blind, placebo-controlled, randomized scientific trial will assess the therapeutic influence of ExoFlo infusion upon the debilitating established of indications, most generally exhaustion and shortness of breath, that severely restrict high quality of lifestyle for a large proportion of people for weeks and months just after the acute COVID-19 an infection has subsided. The infusions will be administered in an outpatient placing.

In accordance to Mark Adams, Co-Founder and Main Executive Officer, “The acceptance to carry on with additional clinical trials less than a new IND validates this amazing extracellular vesicle product or service during a crucial time when 10{46dd52bca0123ad67b2d1222819e83fd0a56e45ca5068239f05f0c514f1e20f9} to 35{46dd52bca0123ad67b2d1222819e83fd0a56e45ca5068239f05f0c514f1e20f9} or much more of these infected with COVID-19 create extended-hauler syndromes. That is at the very least 3.3 to 11.55 million cases in the US by yourself.” He went on to observe “we have witnessed remarkable results that illustrate ExoFlo’s capability to increase the body’s regenerative reaction to the inflammatory destruction brought on by COVID-19. With no reportable adverse activities in either EXIT COVID-19 Period II or the expanded entry program, we really feel particularly self-assured that the last investigation will verify ExoFlo’s potential to help sufferers get better from COVID-19 similar ARDS and also validate its protection profile.”

Vik Sengupta, MD, Chief Medical Officer of Immediate Biologics, said “For lengthy-hauler clients seriously debilitated by what appears to be a sustained inflammatory and probable autoimmune response that persists prolonged soon after recovery from acute COVID-19, it seems that ExoFlo has the opportunity to restore wellbeing and vitality by downregulating persistent inflammation, endorsing revascularization of damaged tissues, and transforming scar tissue that can bring about existence-long restrictions, in particular when these improvements affect the lungs. Not to point out the possibility of increasing neurological manifestations together with mind fog, mood dysfunction, and reduction of smell and style that look to also be a important, if not universally current, function of prolonged-hauler syndromes.” Write-up-acute COVID-19 individuals practical experience a broad vary of extensive-long lasting indicators and other concerns that preclude them from returning to prior baseline health and enjoying their day-to-day lives.

“With no accepted procedure for Write-up-Acute COVID-19 or Long-term Article-COVID-19 syndromes, there is a big unmet general public well being have to have that we consider can be solved by ExoFlo,” stated Direct Biologics’ Co-Founder and President, Joe Schmidt. “In addition, the emergence of new, deadlier, and much more transmissible SARS-Cov-2 variants, and the worldwide explosion of instances in modern months signifies the need to have to convey ExoFlo to the forefront.” 

“We need far better therapeutics for people patients who do come to be unwell, irrespective of whether or not or not effective vaccines have been produced,” mentioned Associate Chief Health-related Officer Sascha Qian Sengupta, MD. “The SARS-Cov-2 variants that have resistance to vaccines and monoclonal antibody therapies pose a bigger chance of death and other difficulties.” 

The Section I/II EIPACS IND acceptance follows on the heels of the productive completion of two medical trials assessing ExoFlo for the remedy of COVID-19 connected acute respiratory distress syndrome  (ARDS) in inpatient and ICU configurations below Immediate Biologics’ initially IND: (1) EXIT COVID-19 (ExoFlo Infusion Treatment for COVID-19 Associated ARDS), a 102 individual Section II, multi-middle, double-blind, randomized, placebo-controlled demo, and (2) EXIT EAP, a 50 patient open-label expanded obtain protocol in which patients much too ill to meet up with acceptance requirements for the Period II demo, had been taken care of under compassionate-use. These trials serve as a prelude to the up coming phase of Immediate Biologics’ ongoing work in the fight versus the COVID-19 pandemic, which will be the world-wide launch later this yr of both of those a randomized, placebo-controlled Stage III scientific demo and an expanded obtain medical demo.

About ExoFlo

ExoFlo is an investigational new drug that has not been accepted or accredited by Food and drug administration. It is an allograft extracellular vesicle item isolated from human bone marrow mesenchymal stem or stromal cells (MSCs). ExoFlo presents signaling proteins that have been shown to modulate inflammation and could promote bioactivity and direct cellular communication.

About Direct Biologics

Direct Biologics, LLC, is headquartered in Austin, Texas, with an R&D facility situated at the University of California, San Diego, and an Operations and Purchase Achievement Heart found in St. Louis, Missouri. Direct Biologics is a industry-top innovator and cGMP maker of regenerative clinical solutions, like a robust line of extracellular vesicle-dependent biological merchandise. The Company was made to develop the science of reducing-edge biologic technologies. Direct Biologic’s management staff holds intensive collective expertise in biologics investigate, enhancement, and commercialization, creating the Company a leader in the evolving, subsequent era segment of the biotherapeutics sector. Immediate Biologics is devoted to pursuing further scientific programs of ExoFlo by the FDA’s investigational new drug application method. For far more details visit www.directbiologics.com.

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Source: Immediate Biologics