Paradigm Therapeutics Secures $12.5 Million Investment to Advance Zorblisa™ Development for Epidermolysis Bullosa
In a promising development for those affected by Epidermolysis Bullosa (EB), Paradigm Therapeutics, Inc. has announced a substantial investment of $12.5 million from Eshelman Ventures, LLC. This funding is aimed at propelling forward the final stages of development for SD-101, also known as Zorblisa™, a topical therapy designed to address the severe skin effects that characterize all subtypes of EB.
Epidermolysis Bullosa is a rare genetic disorder that results in extraordinarily fragile skin, leading to painful blisters and open wounds. Often manifesting from birth, this chronic condition can have devastating effects on patients' lives. Paradigm Therapeutics is committed to developing innovative treatments to relieve the burdens of this debilitating disease.
The investment from Eshelman Ventures will help facilitate the completion of critical activities needed to support a New Drug Application (NDA), which is anticipated to be submitted in the latter half of 2025. In addition, the company is planning to commercialize Zorblisa™ in the United States, providing hope for better treatment options for patients suffering from EB.
Robert Ryan, Ph.D., the CEO of Paradigm Therapeutics, expressed his enthusiasm about the partnership with Eshelman Ventures. He highlighted the pressing need for novel treatment alternatives that can address the comprehensive needs of EB patients. "We are committed to providing a significant therapeutic option for those battling the many challenges posed by this condition," stated Dr. Ryan.
Clinical trials for SD-101 have shown promising results, indicating that it could be the first effective treatment for all forms of EB. The Phase II and Phase III trials, conducted on both pediatric and adult patients, demonstrated the cream's capability in effectively managing the skin lesions and wounds common in these patients. The trials included 217 participants who were administered the daily topical application of Zorblisa™ over a period of three months. The primary outcome measured was target wound closure, alongside additional assessments that noted a reduction in the area affected by blisters and wounds.
Notably, Zorblisa™ has received significant designations from the U.S. Food and Drug Administration (FDA), including Breakthrough Therapy designation and Rare Pediatric Disease designation, emphasizing its potential impact on the treatment landscape for EB. Moreover, the therapy has garnered Orphan Drug designation from both the FDA and the European Commission, pointing towards its critical importance in treating a condition that has largely remained without effective therapies.
Dr. Eshelman, founder of Eshelman Ventures, expressed his commitment to this partnership as both an investor and strategic advisor, emphasizing the urgency to innovate therapies for EB. "Our shared goal is to revolutionize treatment options for patients and meaningfully enhance their quality of life," he remarked.
Paradigm Therapeutics aims to navigate swiftly through the regulatory pathways to make Zorblisa™ available to patients worldwide. The importance of this therapy cannot be overstated, as it targets a historically underrepresented area of medical need, with current options insufficient to meet the complex demands of EB patients.
As Paradigm Therapeutics moves forward with development and preparation for commercialization, the impact of Zorblisa™ on the lives of those affected by Epidermolysis Bullosa remains a beacon of hope. The company is determined to work closely with potential partners to expedite the launch of this much-awaited therapy.
The journey to provide effective treatment options for Epidermolysis Bullosa has taken a significant step forward with this investment, and stakeholders in the medical community are closely watching as Paradigm Therapeutics continues to progress toward its goal of clinical application and improved patient care.
As the company gears up for the next stages of development, the community remains optimistic about the future of Epidermolysis Bullosa treatments, rallying around the transformative potential of Zorblisa™.
Epidermolysis Bullosa is a rare genetic disorder that results in extraordinarily fragile skin, leading to painful blisters and open wounds. Often manifesting from birth, this chronic condition can have devastating effects on patients' lives. Paradigm Therapeutics is committed to developing innovative treatments to relieve the burdens of this debilitating disease.
The investment from Eshelman Ventures will help facilitate the completion of critical activities needed to support a New Drug Application (NDA), which is anticipated to be submitted in the latter half of 2025. In addition, the company is planning to commercialize Zorblisa™ in the United States, providing hope for better treatment options for patients suffering from EB.
Robert Ryan, Ph.D., the CEO of Paradigm Therapeutics, expressed his enthusiasm about the partnership with Eshelman Ventures. He highlighted the pressing need for novel treatment alternatives that can address the comprehensive needs of EB patients. "We are committed to providing a significant therapeutic option for those battling the many challenges posed by this condition," stated Dr. Ryan.
Clinical trials for SD-101 have shown promising results, indicating that it could be the first effective treatment for all forms of EB. The Phase II and Phase III trials, conducted on both pediatric and adult patients, demonstrated the cream's capability in effectively managing the skin lesions and wounds common in these patients. The trials included 217 participants who were administered the daily topical application of Zorblisa™ over a period of three months. The primary outcome measured was target wound closure, alongside additional assessments that noted a reduction in the area affected by blisters and wounds.
Notably, Zorblisa™ has received significant designations from the U.S. Food and Drug Administration (FDA), including Breakthrough Therapy designation and Rare Pediatric Disease designation, emphasizing its potential impact on the treatment landscape for EB. Moreover, the therapy has garnered Orphan Drug designation from both the FDA and the European Commission, pointing towards its critical importance in treating a condition that has largely remained without effective therapies.
Dr. Eshelman, founder of Eshelman Ventures, expressed his commitment to this partnership as both an investor and strategic advisor, emphasizing the urgency to innovate therapies for EB. "Our shared goal is to revolutionize treatment options for patients and meaningfully enhance their quality of life," he remarked.
Paradigm Therapeutics aims to navigate swiftly through the regulatory pathways to make Zorblisa™ available to patients worldwide. The importance of this therapy cannot be overstated, as it targets a historically underrepresented area of medical need, with current options insufficient to meet the complex demands of EB patients.
As Paradigm Therapeutics moves forward with development and preparation for commercialization, the impact of Zorblisa™ on the lives of those affected by Epidermolysis Bullosa remains a beacon of hope. The company is determined to work closely with potential partners to expedite the launch of this much-awaited therapy.
The journey to provide effective treatment options for Epidermolysis Bullosa has taken a significant step forward with this investment, and stakeholders in the medical community are closely watching as Paradigm Therapeutics continues to progress toward its goal of clinical application and improved patient care.
As the company gears up for the next stages of development, the community remains optimistic about the future of Epidermolysis Bullosa treatments, rallying around the transformative potential of Zorblisa™.
Topics Health）
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