The BioPharm Brief: Longer-Acting, Life-Changing, and Fast-Tracked

Welcome to The BioPharm Brief, your daily snapshot of developments shaping the biopharmaceutical industry.

Eyconis has dosed the first patients in a phase 1b/2a trial of EYC-0305, an investigational long-acting anti-VEGF therapy for treatment-naive patients with wet age-related macular degeneration. The therapy is designed to provide sustained drug exposure in the retina, potentially allowing patients to go six months or longer between injections. The OVERTURE study will evaluate safety, tolerability, pharmacokinetics, immunogenicity, and measures of disease activity and vision.

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.