ReAlta Life Sciences Granted FDA Orphan Drug Designation and Fast Track Designation for RLS-0071 for the Treatment of Steroid-Refractory Acute Graft-versus-Host Disease
2024年8月19日 - 10:30PM
ビジネスワイヤ(英語)
Second clinical indication for RLS-0071 to
receive both Orphan Drug Designation and Fast Track Designation,
demonstrating the broad potential of ReAlta’s lead dual-action
complement and innate inflammatory inhibitor
ReAlta Life Sciences, Inc. ("ReAlta" or the “Company”), a
clinical-stage biotech company dedicated to saving lives by
rebalancing the inflammatory response to address rare and acute
inflammatory diseases, today announced that the U.S. Food and Drug
Administration (FDA) has granted Orphan Drug Designation and Fast
Track Designation to RLS-0071, the Company’s lead therapeutic
candidate, for the treatment of hospitalized patients with
steroid-refractory acute graft-versus-host disease (aGvHD).
aGvHD is a serious and often fatal complication following
hematopoietic stem cell transplantation. It occurs when the donor's
immune cells attack the recipient's tissues, leading to severe
inflammation and tissue damage. Patients who do not respond to
standard steroid treatments have limited therapeutic options and
face a high risk of mortality. There are approximately 4,000
steroid-refractory aGvHD patients in the U.S., EU and Japan.
RLS-0071, an investigational medicine based on the Company’s
novel EPICC peptide platform, aims to address this unmet medical
need by leveraging its unique ability to modulate the complement
and innate inflammatory pathways, offering a new hope for patients
with this devastating condition. The Company is currently
conducting a Phase 2, open label clinical trial of RLS-0071 in
hospitalized patients with steroid-refractory aGvHD. For further
details on this trial, please visit clinicaltrials.gov
(NCT06343792).
"We are thrilled to receive both Orphan Drug and Fast Track
Designations for RLS-0071 for the treatment of steroid-refractory
acute graft-versus-host disease, underscoring the significant
potential of RLS-0071 and its novel dual mechanism-of-action to
address critical unmet needs for patients with this
life-threatening condition," said Kenji Cunnion, MD, MPH, Chief
Medical Officer of ReAlta. "RLS-0071 may address limitations of
current treatment options for patients with aGvHD. We remain
committed to advancing our clinical development program with the
hope of bringing this promising therapy to patients as quickly as
possible."
The FDA's Orphan Drug Designation is granted to investigational
therapies intended for the treatment of rare diseases or conditions
that affect fewer than 200,000 people in the United States. This
designation provides ReAlta with certain benefits, including seven
years of market exclusivity upon regulatory approval, exemption
from FDA application fees, and tax credits for qualified clinical
trials.
In addition to the Orphan Drug Designation, RLS-0071 has also
received FDA Fast Track Designation for the treatment of aGvHD.
Fast Track is a process designed to facilitate the development and
expedite the review of drugs that treat serious conditions and fill
an unmet medical need. This designation allows for more frequent
interactions with the FDA and the potential for Priority Review,
ultimately accelerating the timeline for bringing RLS-0071 to
patients in need.
The Company is also currently conducting Phase 2 clinical trials
of RLS-0071 in newborns with hypoxic-ischemic encephalopathy (HIE)
(NCT05778188) and hospitalized patients with acute exacerbations of
chronic obstructive pulmonary disease (NCT06175065).
About ReAlta Life Sciences
ReAlta Life Sciences, Inc. is a clinical mid-stage biotech
company dedicated to saving lives by rebalancing the inflammatory
response to address life threatening acute inflammatory and rare
diseases. The Company’s EPICC peptides are based on research into
the human astrovirus, HAstV-1, which causes a non-inflammatory,
self-limiting gastroenteritis unique among viruses by inhibiting
components of the innate immune system. ReAlta’s therapeutic
peptides leverage these virus-derived mechanisms to rebalance
complement and inflammatory processes in the body. The Company’s
pipeline is led by RLS-0071, which has received IND clearance,
Orphan Drug Designation, and Fast Track Designation by the U.S.
Food and Drug Administration (FDA) , and Orphan Drug Designation by
the European Medicines Agency, for the treatment of
hypoxic-ischemic encephalopathy (HIE); IND clearance, Orphan Drug
Designation, and Fast Track Designation by the FDA for the
treatment of acute graft-versus-host disease (aGvHD); and IND
clearance by the FDA for the treatment of acute exacerbations of
chronic obstructive pulmonary disease. The company launched in 2018
and is located in Norfolk, Virginia and Aguadilla, Puerto Rico. For
more information, please visit www.realtalifesciences.com.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240819089603/en/
Media and Investor Contact: John Rickman Chief Financial Officer
jrickman@realtals.com