#USA #Epidermolysis Bullosa #Paradigm Therapeutics #Mt Pleasant #SD-101

Paradigm Therapeutics Secures Additional Funding for SD-101 Development

Paradigm Therapeutics, Inc., a biopharmaceutical company based in the United States, recently made headlines by announcing an additional investment of $12.6 million from Eshelman Ventures, LLC. This new funding is set to significantly boost the global development and registration of SD-101, an innovative topical therapy aimed at treating Epidermolysis Bullosa (EB), a rare genetic skin disorder characterized by fragile skin that blisters and tears easily.

Overview of the Investment

This latest investment brings Eshelman Ventures' total funding for Paradigm Therapeutics in 2025 to $25.1 million. The funds will be primarily used for manufacturing development and expediting the anticipated commercial launch of the SD-101 program worldwide. Dr. Eshelman will continue his role as a key strategic advisor for the company.

Urgency and Purpose of SD-101

The urgency of bringing SD-101 to market cannot be understated. Epidermolysis Bullosa is a debilitating disorder that impacts individuals from infancy, leading to severe blistering and open wounds throughout their lives. Currently, there are no approved therapies specifically designed to treat the entire skin surface for all subtypes of EB, making SD-101 a groundbreaking therapeutic option.

Dr. Robert Ryan, CEO of Paradigm Therapeutics, emphasized the significance of SD-101, stating, "This funding allows us to not only accelerate our efforts in advancing SD-101 but also to ensure that patients living with Epidermolysis Bullosa receive the treatment they desperately need. Our objective is to collaborate with global regulators to provide a solution that effectively addresses the needs of all EB patients, irrespective of their subtype."

The clinical results thus far have been promising, with beneficial effects observed in patients across various subtypes of EB. The data supporting SD-101's efficacy is derived from both Phase II and Phase III trials, which highlighted its capability to treat lesions and wounds that cover the entire skin surface of EB patients.

Clinical Trials and Results

In the conducted trials, 217 EB patients, including both children and adults, were treated with SD-101 applied topically to the entire body daily for three months. The primary outcomes measured included wound closures, while the secondary outcomes tracked the reduction in the body surface area affected by blisters and lesions. Notably, SD-101 has shown a favorable safety profile for long-term use, which is especially crucial given EB patients often face chronic health challenges.

One of the remarkable findings from the trials was that whole-body treatment with SD-101 notably reduced the incidence of skin infections — a common cause of severe complications and mortality in EB patients. The promising results of these studies led to SD-101 being granted the FDA's Breakthrough Therapy designation, an essential milestone that reflects its potential impact in the treatment landscape of EB.

About Epidermolysis Bullosa

Epidermolysis Bullosa is a chronic, genetic disorder with various forms that all share the common ailment of exceedingly fragile skin. Individuals with EB experience severe blistering and open wounds that can be exacerbated by minimal friction or trauma. Given that EB can lead to disfigurement and, in severe cases, can be life-threatening, the need for more effective treatment options has never been more pressing.

Conclusion

Paradigm Therapeutics aims to finalize the registration process for SD-101 while seeking strategic partnerships to enhance its market entry. As research continues and further data emerges from clinical studies, the hope is that SD-101 will pave the way for a new standard of care for those suffering from Epidermolysis Bullosa, offering them a much-needed respite from their debilitating conditions. With this additional funding, Paradigm Therapeutics is taking significant steps towards making that hope a reality.

For more information, please contact:
Dr. Robert Ryan
Chief Executive Officer
Email: [email protected]
(919)-274-0703