PR95675

AUSTIN, Texas, April 27, 2022 /PRNewswire=KYODO JBN/ --

Direct Biologics (https://c212.net/c/link/?t=0&l=en&o=3515622-1&h=961943011&u=https%3A%2F%2Fwww.directbiologics.com%2F&a=Direct+Biologics), a regenerative biotechnology company with a groundbreaking extracellular

vesicle (EV) platform technology, announced today that the FDA has approved the

company to proceed with its Phase 3 clinical trial using its investigational EV

drug, ExoFlo, to treat Acute Respiratory Distress Syndrome (ARDS) due to

Covid-19. Direct Biologics is the first and only EV company to receive FDA

Phase 3 approval for an Investigational New Drug (IND) indication to date.

The Phase 3 trial will be conducted under the auspices of the first

Regenerative Medicine Advanced Therapy (RMAT) designation approved by the FDA

for an EV therapeutic, making Direct Biologics one of only 70 companies in the

history of the FDA to have been officially awarded RMAT.  Like the fast track

and breakthrough designations, the RMAT was created by the FDA to expedite

approval for promising regenerative medicines which demonstrate the ability to

treat serious life-threatening diseases.

"Receiving FDA approval for Phase 3 is a key milestone for Direct Biologics,"

said Mark Adams, Co-Founder and CEO.  "Coupled with the RMAT designation, we

are now on an accelerated path towards commercialization with a potential

life-saving drug—ExoFlo.  This Phase 3 trial titled "Extinguish Covid-19" is an

international, multicenter, double-blind, randomized, placebo-controlled Phase

3 trial.  Our objective is to enroll patients with ARDS in hospital sites

across US, Spain, India, Jordan, Egypt, Lebanon, and South Africa, and to

demonstrate a significant mortality reduction following treatment with ExoFlo

compared to standard of care alone.  As pioneers in the field of regenerative

medical therapies, we at Direct Biologics are changing the future of medicine."

"Whether Covid-19 remains a pandemic or becomes an endemic, one area of unmet

need remains the same: an effective therapeutic for ARDS. People over age 65

and those with comorbidities, once infected with SARS-CoV-2, will always be

vulnerable to progression to severe infection and ARDS," said Joe Schmidt,

Co-Founder and President.  "Revealing robust safety and a promising 60-day

mortality reduction, our Phase 2 trial showed that ExoFlo can make a profound

life-saving difference for patients hospitalized with ARDS. Receiving FDA

approval to proceed to Phase 3 is a monumental achievement because there is no

known treatment for ARDS. Physicians and patients across the world have long

been waiting for a solution."

"Working to develop ExoFlo is a privilege," said Dr. Vik Sengupta, Chief

Medical Officer. "The growing body of clinical data indicates that ExoFlo is a

drug that brings hope to the treatment of a disease for which the standard of

care has not improved in decades. This hope is most poignantly captured by the

stories of patients who have received ExoFlo for treatment. Just last week, a

woman in Virginia (https://c212.net/c/link/?t=0&l=en&o=3515622-1&h=1592598421&u=https%3A%2F%2Ffredericksburg.com%2Fnews%2Flocal%2Fwith-prayers-and-medicine-stafford-woman-makes-miraculous-recovery-after-covid%2Farticle_ec2c27b6-aaba-5221-bfc7-2a4b9d545950.html&a=woman+in+Virginia) was reunited with her children

after languishing on mechanical ventilator for 2 months due to developing ARDS

induced by Covid-19.  But in a final attempt to save the patient's life, 

the ICU physicians petitioned to treat her with ExoFlo

under compassionate use, and she made a miraculous recovery.  There are

millions of people like her who never make it out of the hospital.  We want to

change that story by establishing ExoFlo as the gold standard treatment for

ARDS and making it accessible to patients in hospitals around the world."

About Direct Biologics  

Headquartered in Austin, TX, Direct Biologics is a market-leading innovator and

cGMP manufacturer of regenerative medicine products.  The flagship product,

ExoFlo, contains thousands of signals in the form of regulatory proteins,

microRNA, and messenger RNA that are responsible for cell-to-cell

communication.  ExoFlo harnesses the natural healing power of mesenchymal stem

cells (MSC) without requiring the addition of stem cells themselves.  

Physicians can learn more at www.clinicaltrials.gov. For more information on

Direct Biologics and regenerative medicine, visit www.directbiologics.com.

SOURCE: Direct Biologics

CONTACT: Katherine Collins, kcollins@directbiologics.com, +1-361-563-7259