for PKM-01, for local treatment of gout flares, directly by a Phase 2 trial.
PK MED, a biotechnology company developing injectable smart implants for drug release in rheumatology and cell homing for bone marrow transplantation, today announced a significant potential breakthrough in the fight against gout, a form of arthritis that is widespread throughout the world. During a Type B pre-IND meeting1, the Food and Drug Administration gave its clearance to directly initiate the clinical program for PKM-01 with a phase 2 trial for gout patients, without undertaking phase 1 studies. PKM-01 is a local intra-articular injection treatment for gout flares, developed by PK MED, aiming to provide a fast an effective pain relief and powerful and safe anti-inflammatory effect. Thanks to its low-risk toxicity profile, PKM-01’s clinical program will start directly in phase 2, which should considerably speed up time-to-market.