Xinnate receives Orphan Drug Designation from US FDA for TCP-25
Xinnate receives Orphan Drug Designation from US FDA for TCP-25
Xinnate AB today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for the company’s drug candidate TCP-25 for the treatment of the severe disease Epidermolysis Bullosa (EB).
"We are excited about FDA’s decision to grant ODD for TCP-25, recognizing its unique mechanism of action, the robust data generated during preclinical and clinical development and the significant unmet medical needs of patients suffering from EB. This designation underscores the potential of TCP-25 as a transformative treatment option and will facilitate our efforts to bring this therapy to patients who needs it most,” said Helene Hartman, CEO of Xinnate.
TCP-25 is an immunomodulatory peptide being developed by Xinnate for the treatment of the rare, devastating disease EB as well as other conditions involving inflammation and infection in skin and wounds. TCP-25 has demonstrated dual-action capabilities, targeting both inflammation and bacterial infection to promote faster and more effective healing. The FDA grants OODs to support the development of therapies for rare disorders affecting fewer than 200,000 people in the US. The designation qualifies a company for several benefits, including tax credits, exemptions from certain FDA fees for clinical trials, and seven years of market exclusivity following drug approval.
For more information, please contact:
Helene Hartman, CEO of Xinnate, helene.hartman@xinnate.com
About Xinnate AB
Xinnate is a clinical-stage pharmaceutical company pioneering novel therapies based on a proprietary peptide technology. These therapies aim to address dysfunctional healing by targeting the interplay of microbial presence and inflammatory responses. With an ambitious development program, Xinnate is dedicated to transforming the lives of patients with Epidermolysis Bullosa and other inflammatory skin conditions. A three-part Phase 1 study of the first drug candidate, TPC-25 gel, has been completed including a group of patients with Epidermolysis Bullosa. The phase 2 study is planned to start during 2025.
Xinnate AB partners with Destum Partners, Inc. a leading global, advisory firm
Lund, Sweden – Xinnate AB today announced a strategic collaboration with Destum Partners, Inc., a leading global, advisory firm specializing in the life sciences sector. Under the agreement, Destum Partners will act as the exclusive advisor to Xinnate AB for identifying and developing partnership opportunities for TCP-25 gel, the company’s innovative drug candidate for the treatment of Epidermolysis Bullosa (EB). EB is a group of rare, often very severe inflammatory disorders which causes fragile, blistering skin, resulting in recurring and chronic wounds.
“Following our positive Phase 1 data, including patients with Dystrophic EB, we sought the expertise of Destum Partners to support our mission of finding the right partner to advance TCP-25 gel and bring this much-needed treatment to patients,” said Helene Hartman, CEO of Xinnate AB. “With Destum Partners’ guidance, we are now ramping up our partnering activities, including introducing TCP-25 to potential strategic partners at the upcoming JP Morgan Healthcare Conference in January.”
“TCP-25 is an exciting drug candidate that has already attracted significant interest,” added Tom Filipczak, Managing Director and Partner at Destum Partners. “We are thrilled to collaborate with the Xinnate team and contribute to their efforts to unlock the full potential of TCP-25 through strategic partnerships.”
For more information
Helene Hartman, CEO of Xinnate AB
Helene.hartman@xinnate.com
Phone: +46 (0)72-512 03 12
About Destum Partners, Inc.
Destum Partners, Inc. (www.destumpartners.com) is a global, advisory and consultancy firm specializing in the biopharmaceutical and life sciences industries. For more than 18 years, Destum Partners has worked with clients ranging from large, multinational Fortune 500 companies through mid-sized/early-stage companies, globally completing transactions and providing customized market research and valuations. Destum Partners is therapeutically agnostic and has completed over USD $5.15B in deal value.