GC Biopharma Partners with Hanmi to Advance Fabry Treatment
GC Biopharma and Hanmi Pharmaceutical Make Breakthrough in Fabry Treatment
In an exciting development for patients suffering from Fabry disease, GC Biopharma has announced that its collaborative project with Hanmi Pharmaceutical has achieved Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration (FDA). This breakthrough marks the beginning of a Phase 1/2 clinical trial for their innovative treatment known as LA-GLA (GC1134A/HM15421).
Introducing LA-GLA: A Revolutionary Approach
LA-GLA represents a significant shift in how Fabry disease may be treated. This innovative drug is touted as the world’s first once-monthly subcutaneous treatment aimed at enhancing the quality of life for those affected by this rare genetic disorder. Rather than the conventional intravenous administration that demands frequent hospital visits, LA-GLA offers an easier, more user-friendly option.
Understanding Fabry Disease
Fabry disease, a rare genetic disorder, is classified as a Lysosomal Storage Disease (LSD), primarily impacting individuals due to a deficiency in the alpha-galactosidase A enzyme. This deficiency results in the harmful accumulation of glycolipids, leading to toxic effects on cells and causing chronic damage to various organs. The consequences can escalate to serious health issues and, in extreme cases, may be life-threatening.
Challenges with Current Treatments
Currently, treatments primarily involve Enzyme Replacement Therapy (ERT), which necessitates intravenous infusions every two weeks. This method can be burdensome, often leading to considerable inconvenience for patients and their families. Moreover, the continuous nature of these treatments often fails to adequately halt the progression of kidney disease.
Key Benefits of LA-GLA
LA-GLA has been developed specifically to address the limitations associated with current ERT methods. By offering a once-monthly subcutaneous injection, it significantly enhances patient convenience. Preclinical studies have indicated that LA-GLA not only improves kidney function but also shows superior efficacy in the management of vascular complications and peripheral nerve disorders compared to existing therapies.
Recognition by the FDA
Due to its promising attributes, LA-GLA was granted Orphan Drug Designation by the FDA, underscoring its potential impact on patient care in treating this rare disorder.
Collaboration Explaining the Approach
Both GC Biopharma and Hanmi Pharmaceutical bring their depth of experience to this project, ensuring adherence to FDA clinical protocols while also merging their specialized knowledge. This collaboration is designed to expedite the clinical transition, aiming to deliver effective new treatment options for Fabry disease.
About GC Biopharma Corp.
GC Biopharma Corp., formerly known as Green Cross Corporation, is a prominent biopharmaceutical company, dedicated to the development and distribution of life-saving protein therapeutics and vaccines. Based in Yongin, South Korea, it stands as a leading manufacturer of plasma proteins and vaccines, committed to enhancing healthcare solutions for more than 50 years.
Contact Information
For further inquiries, you can reach out to the media contacts at GC Biopharma:
- Sohee Kim
[email protected] - Yelin Jun
[email protected] - Rachel Kim
[email protected]
Frequently Asked Questions
What is LA-GLA?
LA-GLA is an innovative new treatment for Fabry disease developed by GC Biopharma and Hanmi Pharmaceutical, offering a once-monthly subcutaneous injection.
How does Fabry disease affect patients?
Fabry disease is a genetic disorder that leads to the harmful accumulation of glycolipids, causing damage to multiple organs and leading to severe health complications.
What makes LA-GLA different from current treatments?
Unlike traditional intravenous treatments, LA-GLA is administered subcutaneously once a month, significantly improving convenience and efficacy for patients.
What is the status of LA-GLA's development?
LA-GLA has received IND clearance from the FDA and will enter Phase 1/2 clinical trials to evaluate its safety and effectiveness.
Who can I contact for more information?
For additional details, you can reach out to the press contacts listed above at GC Biopharma.
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