ReAlta Life Sciences Doses First Patient in Phase 2 Trial
ReAlta Life Sciences Doses First Patient in Phase 2 Trial
NORFOLK, Va. — ReAlta Life Sciences, Inc. ("ReAlta" or the "Company") has reached an important milestone by announcing that the first patient has been dosed in its Phase 2 clinical trial evaluating RLS-0071. This investigational medication is designed for hospitalized patients suffering from moderate to severe steroid-refractory acute graft-versus-host disease (aGvHD). This condition is a serious and often life-threatening complication that can arise following hematopoietic stem cell transplantation.
The Importance of Hematopoietic Stem Cell Transplantation
Hematopoietic stem cell transplantation stands as one of the most transformative therapies available for individuals battling cancer, autoimmune disorders, sickle cell disease, and other critical health issues. However, post-transplant complications such as acute graft-versus-host disease can pose substantial risks, causing severe inflammation and tissue damage as the immune cells from the donor attack the patient’s body. Dr. Kenji Cunnion, Chief Medical Officer at ReAlta, expresses optimism regarding RLS-0071, highlighting its potential to improve patient outcomes amidst this challenging complication.
Understanding Steroid-Refractory aGvHD
For patients with aGvHD who do not respond adequately to conventional steroid treatments, options are limited. This lack of effective treatment leads to increased inflammation, significant organ damage, and a heightened risk of mortality. In the U.S., EU, and Japan, it is estimated that around 4,000 patients annually develop steroid-refractory aGvHD, underscoring the urgency for innovative therapies like RLS-0071.
Introducing RLS-0071
RLS-0071 represents a novel approach in treatment, stemming from ReAlta's groundbreaking EPICC peptide platform. This investigational medicine aims to fill the existing therapeutic gaps by utilizing its dual-targeting mechanism to modulate both complement and innate inflammatory pathways. Recently, RLS-0071 received Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA), affirming its promise in addressing unmet medical needs.
RLS-0071 in Clinical Trials
Beyond its focus on aGvHD, the Company is also conducting Phase 2 trials for RLS-0071 in newborns diagnosed with hypoxic ischemic encephalopathy (HIE) and for patients suffering from acute exacerbations of chronic obstructive pulmonary disease (AE-COPD). These studies are pivotal as they explore the full therapeutic potential of RLS-0071 across various patient populations.
About the Ongoing Phase 2 Study
The Phase 2 clinical trial is an open-label, prospective, dose-escalation study designed to evaluate the safety, tolerability, and efficacy of RLS-0071 for treating steroid-refractory aGvHD in hospitalized patients. The primary objectives include assessing safety and the overall response rate among participants receiving RLS-0071 as either a standalone treatment or in conjunction with standard-of-care therapies.
ReAlta Life Sciences Overview
Founded in 2018 and headquartered in Norfolk, Virginia, ReAlta Life Sciences, Inc. is dedicated to saving lives through innovative biopharmaceutical solutions targeting rare and acute inflammatory diseases. At the heart of their therapeutic approach is the EPICC peptide platform, which leverages unique properties derived from the human astrovirus. This platform aims to inhibit dangerous inflammatory responses and prevent tissue damage caused by overactive immune mechanisms. The company’s commitment has led to several designations from regulatory bodies, highlighting its dedication to tackling serious diseases like HIE, aGvHD, and AE-COPD.
For more information about their ongoing studies and updates, visit ReAlta Life Sciences.
Frequently Asked Questions
What is RLS-0071?
RLS-0071 is an investigational drug being developed by ReAlta Life Sciences for the treatment of steroid-refractory acute graft-versus-host disease (aGvHD).
Why is RLS-0071 significant?
This medication has a unique dual mechanism of action that targets inflammatory pathways, potentially providing new hope for patients with severe complications from stem cell transplants.
How many patients develop steroid-refractory aGvHD annually?
Approximately 4,000 patients develop steroid-refractory aGvHD each year across the U.S., EU, and Japan, indicating a crucial need for effective treatments.
What designations has RLS-0071 received?
RLS-0071 has been granted Orphan Drug Designation and Fast Track Designation by the U.S. FDA, enhancing its development pathway and access for patients.
When did ReAlta Life Sciences begin its operations?
ReAlta Life Sciences was established in 2018, positioned to innovate care for serious inflammatory diseases.
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