Advanced therapeutic approaches, including cell and gene therapies, are emerging as promising strategies for managing diabetes and its complications, addressing a global health challenge affecting millions.
ProKidney Prioritizes US Trial for Rilparencel in Type 2 Diabetes and Chronic Kidney Disease
ProKidney is now focusing on its phase 3 REGEN-006 (PROACT 1) clinical trial (NCT05099770) in the United States, which is evaluating rilparencel, a renal autologous cell therapy, for patients with type 2 diabetes (T2D) and chronic kidney disease (CKD). The company discontinued the phase 3 REGEN-016 (PROACT 2) clinical trial (NCT05286853) in Spain, determining it unnecessary for US regulatory approval. Rilparencel has received regenerative medicine advanced therapy (RMAT) designation from the FDA, potentially expediting its approval. Topline findings from PROACT 1 are expected in the third quarter of 2027. The PROACT 1 trial is a randomized, blinded, sham-controlled study expected to enroll around 685 patients, focusing on those with stage 4 CKD and late stage 3b CKD with albuminuria.
Amarna Therapeutics Gains FDA Guidance for AM510 Diabetes Gene Therapy
Amarna Therapeutics has received regulatory guidance from the FDA regarding AM510, its investigational gene therapy product for type 1 diabetes (T1D). The feedback, obtained during an INTERACT meeting, covered chemistry, manufacturing, and controls; the nonclinical program; and the planned clinical trial design from a safety perspective. Amarna plans to incorporate this feedback as it progresses towards submitting an investigational new drug (IND) application, with a pre-IND meeting anticipated in less than 2 years. Henk Streefkerk, MD, PhD, the chief executive officer and medical director of Amarna Therapeutics, stated the company is eager to push forward with preclinical work to start treating and potentially curing T1D patients as soon as possible.
Vertex's Diabetes Cell Therapy VX-880 Shows Promise in Eliminating Severe Hypoglycemic Events
Data from the phase 1/2 FORWARD trial (NCT04786262) of VX-880 (Vertex Pharmaceuticals) continue to support its potential to eliminate or reduce the need for insulin in patients with T1D. Updated data were presented at the American Diabetes Association 84th Scientific Sessions by investigator Piotr Witkowski, MD, PhD. Witkowski noted that the positive data adds to the growing body of evidence for VX-880’s potential to revolutionize T1D treatment, offering an alternative solution to exogenously administered insulin. These findings will support further evaluation of VX-880, with hopes that it will become a pivotal development in T1D care.
PolarityTE Screens First Patient for SkinTE Trial Targeting Diabetic Foot Ulcers
The first patient with Wagner grade 1 diabetic foot ulcers (DFUs) has been screened for a phase 3 pivotal trial (NCT06140303) of SkinTE, an autologous heterogenous skin construct (AHSC) based on PolarityTE’s proprietary minimally polarized functional unit (MPFU) technology. The trial, named "Closure Obtained with Vascularized Epithelial Regeneration for DFUs with SkinTE II," or "COVER DFUS II", will be conducted under PolarityTE’s open IND for SkinTE. David Armstrong, DPM, PhD, Professor of Surgery and director, Southwestern Academic Limb Salvage Alliance (SALSA), Keck School of Medicine, highlighted the high risk of amputation, hospitalization, and even death for patients with DFUs, expressing enthusiasm for evaluating a promising therapy that might help reduce suffering for these patients and their families.
