PRA-216 / Prana Therapies - LARVOL DELTA

Late Breaking Abstract - PRA-216, a long-acting bispecific IL-4Rα/TSLP antibody, demonstrates favorable safety, extended exposure, and durable pharmacodynamic activity in a Phase 1 study of healthy volunteers (ERS 2026) - "These results demonstrate that PRA-216 was safe and well tolerated and exhibited extended exposure and durable PD activity, positioning PRA-216 as a potential best-in-disease therapeutic with infrequent dosing across respiratory and inflammatory diseases. Phase 2 studies in asthma and COPD are advancing."

Bispecific • Clinical • Late-breaking abstract • P1 data • PK/PD data • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Respiratory Diseases • IL13 • IL4 • STAT6 • TSLP

PRA-216 Atopic Dermatitis Safety and Efficacy Study (clinicaltrials.gov) - P2 | N=39 | Not yet recruiting | Sponsor: Prana Therapies Inc

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Phase 2 development of PRA-216 in asthma, chronic obstructive pulmonary disease (COPD), and atopic dermatitis has been initiated with patient data from all three trials expected in 2027. (GlobeNewswire)

P2 data • Trial status • Asthma • Atopic Dermatitis • Chronic Obstructive Pulmonary Disease • Immunology

Prana Therapies Announces Positive Phase 1 Results for PRA-216, a Novel IL-4Rα/TSLP Bispecific Antibody, Supporting Its Potential Best-in-Disease Profile and Providing the First Clinical Validation of Prana’s INSPIRE Multispecific Platform (GlobeNewswire) - "The MAD cohorts were dosed every two weeks for three doses. PRA-216 was well-tolerated, with no serious or Grade ≥3 treatment-emergent adverse events, no injection site reactions, and no reports of conjunctivitis. PRA-216 achieved 85% subcutaneous bioavailability and demonstrated an extended half-life with high, sustained exposure, supporting the potential for maintenance dosing as infrequently as every 12 weeks."

Late-breaking abstract • P1 data • PK/PD data • Asthma • Immunology

PRA-216 COPD Safety and Biomarker Study (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Prana Therapies Inc

Biomarker • New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Inflammation • Pulmonary Disease • Respiratory Diseases

Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma (clinicaltrials.gov) - P1/2 | N=96 | Recruiting | Sponsor: Prana Therapies Inc | Not yet recruiting ➔ Recruiting

Enrollment open • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases