In Australia, Hansa Biopharma has reported the first commercial use of imlifidase, marketed as Idefirix, for a kidney transplant. The treatment was used in a highly sensitized patient with a positive crossmatch with the donor. Imlifidase rapidly cleaves IgG antibodies, including donor-specific antibodies, potentially enabling transplantation for patients who might otherwise have difficulty finding a compatible donor. The therapy is already approved in several markets, while Hansa’s US application is under FDA review.
And Consano Bio’s C-1101 has received FDA Fast Track designation for chronic lumbosacral radiculopathy, commonly known as chronic sciatica. The investigational platelet-derived biologic is designed to modulate inflammation and support cellular repair following nerve injury. The designation follows FDA clearance of the company’s IND, with a phase 1 randomized, controlled study now planned to evaluate C-1101 in patients with chronic sciatica.
That’s The BioPharm Brief for today. Thanks for listening. For analysis and expert insights, please visit BioPharmInternational.com.
Key takeaways:
- Eyconis has entered the clinic with EYC-0305, an investigational anti-VEGF therapy designed for six-month or longer dosing intervals in wet AMD.
- Hansa’s imlifidase has now been used commercially in Australia to help enable a kidney transplant for a highly sensitized patient.
- Consano Bio’s C-1101 received FDA Fast Track designation as it advances into phase 1 testing for chronic sciatica.
