#USA #Mount Pleasant #Paradigm Therapeutics #Eshelman Ventures #SD-101

Paradigm Therapeutics Secures Investment for Epidermolysis Bullosa Treatment

Paradigm Therapeutics, Inc., a biopharmaceutical pioneer, has recently announced a significant new financial boost to its promising treatment for Epidermolysis Bullosa (EB). The company secured an additional $12.6 million investment from Eshelman Ventures, LLC, marking a total of $25.1 million raised in 2025 alone. This funding will play a vital role in expediting the global development and launch of SD-101, a topical therapy designed to address the intricate needs of those with EB.

Background on Epidermolysis Bullosa

Epidermolysis Bullosa is a severely debilitating genetic condition characterized by extremely fragile skin that is prone to blistering and open wounds. This condition can manifest from birth and varies in severity across different subtypes, with patients often facing challenges throughout their lives due to the chronic nature of the disease.

Despite its impact, there currently are no approved therapies that treat the entire skin surface across all EB subtypes, which makes Paradigm's SD-101 a groundbreaking advancement.

SD-101: A Revolutionary Topical Therapy

SD-101 is being developed as a whole-body topical treatment for EB patients, aiming to relieve the distress caused by skin lesions and wounds. The funding will be utilized to facilitate the acceleration of numerous activities related to the anticipated commercial launch of the SD-101 program on a global scale, including both manufacturing and regulatory efforts.

In statements made by Dr. Robert Ryan, the company’s CEO, he emphasized the importance of this additional investment: “The opportunity to bring in additional investment for the SD-101 program will allow Paradigm to accelerate activities as we work towards bringing SD-101 to patients living with Epidermolysis Bullosa globally.”

He further noted that the clinical data gathered thus far suggests that SD-101 could be a game-changer for patients suffering from EB, demonstrating capabilities to provide a comprehensive treatment option for the various forms of this disease.

Clinical Trials and Efficacy

The results from the Phase II and Phase III clinical trials featuring 217 patients — both pediatric and adult — have shown promising outcomes. SD-101 was applied daily over the entire body for a three-month period, leading to significant improvements in wound closure and a marked reduction in the area affected by blisters and skin lesions. Moreover, it has exhibited a favorable safety profile, which is crucial for long-term treatment considerations. Notably, the therapy also appears to diminish the frequency of skin infections, which are common complications in EB and can lead to increased morbidity.

Regulatory Status and Future Prospects

SD-101 is noteworthy for being the first treatment for EB to receive the FDA's Breakthrough Therapy Designation, which is an important marker of its potential effectiveness. It has also been granted Rare Pediatric Disease designation and Orphan Drug designation from both the FDA and the European Commission, further streamlining its path toward approval.

Upon successful approval, Paradigm Therapeutics stands to gain a Priority Review Voucher (PRV), enhancing the strategic advantages associated with their market entry plans.

Conclusion

Paradigm Therapeutics is stepping into a crucial role within the biopharmaceutical landscape, particularly in addressing unmet medical needs for patients suffering from Epidermolysis Bullosa. With the critical funding from Eshelman Ventures and a promising treatment in SD-101, the company is poised to make significant strides not only for clinical development but also for the hope and wellbeing of countless patients worldwide.

This upcoming journey towards registration and commercialization will potentially transform the therapeutic landscape for Epidermolysis Bullosa, giving hope to patients and families who are affected by the realities of this challenging condition.