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

• Rapid, deep, and durable pharmacodynamic activity demonstrated across key Type 2 inflammatory biomarkers, including pSTAT6, TARC, eosinophils, and IgE
  
• Extended half-life and 85% subcutaneous bioavailability support the potential for single-injection, at-home maintenance dosing as infrequently as every 12 weeks
  
• Phase 2 development in asthma, COPD, and atopic dermatitis has been initiated
  
• Results support Prana's broader strategy to develop differentiated half-life-extended multispecific therapeutics
  

SAN DIEGO, Sept. 08, 2026 (GLOBE NEWSWIRE) -- Prana Therapies, Inc. (“Prana”), a clinical-stage biotechnology company pioneering next-generation half-life-extended multispecific antibodies designed to deliver best-in-disease therapies, today announced positive Phase 1 results for PRA-216, its lead clinical program and a fully human, half-life-extended bispecific antibody developed on Prana's proprietary INSPIRE platform. PRA-216 targets IL-4Rα and TSLP, combining broad downstream blockade of IL-4/IL-13 signaling with upstream TSLP inhibition to address complementary drivers of inflammation. The Phase 1 data were presented at the European Respiratory Society (ERS) International Congress 2026 in Barcelona, Spain (Late Breaker Poster #5809).

The placebo-controlled Phase 1 study enrolled 57 healthy adults across seven single- and multiple-ascending-dose (SAD and MAD) cohorts with doses up to 1,200 mg administered intravenously and up to 600 mg subcutaneously. 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.

PRA-216 demonstrated rapid, deep, and durable pharmacodynamic activity across multiple key Type 2 inflammatory biomarkers, including inhibition of pSTAT6 (100%) and reductions in serum TARC (50%), blood eosinophils (100%) and IgE (25%), for at least 12 weeks in the 600 mg MAD cohort. Together, these results are consistent with sustained dual inhibition of the IL-4Rα and TSLP pathways and support the potential for differentiated, deeper disease control with infrequent dosing.

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.

“These results reinforce our view that PRA-216 has the potential to drive more rapid, deeper, and more durable responses across a broad patient population while offering infrequent dosing for greater patient convenience,” said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Prana.“We're also thrilled to see the first clinical validation of our INSPIRE platform and an important proof point for Prana's broader strategy.”

“Physicians and patients continue to need therapies that can deliver better disease control while reducing treatment burden,” said Dr. Ian Pavord, Respiratory Medicine, University of Oxford and Advisor to Prana.“The robust pharmacodynamic activity and long-acting profile observed with PRA-216 are highly encouraging and support its potential as a differentiated therapy for patients with asthma and COPD.”

PRA-216 is the first clinical program generated from Prana's proprietary INSPIRE platform, which has generated a pipeline of half-life-extended, fully IgG-based multispecific antibodies designed to overcome key limitations of conventional multispecific formats, including challenges with half-life, stability, manufacturability, immunogenicity, and subcutaneous delivery.

About PRA-216
Prana's lead program, PRA-216, is a novel IL-4Rα/TSLP bispecific antibody generated from the INSPIRE platform and currently in Phase 2 development for asthma, COPD and atopic dermatitis.

About Prana Therapies
Prana Therapies is a clinical-stage biotechnology company pioneering a new generation of half-life-extended multispecific antibodies designed to deliver best-in-disease therapies. Through its proprietary INSPIRE platform, Prana combines complementary therapeutic mechanisms in fully IgG-based molecules designed for differentiated efficacy, extended exposure and convenient dosing.

About Prana's INSPIRE Platform
The Prana INSPIRE platform addresses key challenges that have historically limited multispecific antibodies by combining fully IgG-based architectures with favorable developability, manufacturability, safety, and extended half-life. INSPIRE enables Prana to combine complementary therapeutic mechanisms in a single molecule while preserving the drug-like properties needed for convenient, chronic treatment.

Prana is advancing a wholly-owned pipeline of additional INSPIRE-based bispecific and trispecific programs across diseases with significant unmet need.

Contact
Christina Trout
VP, Corporate Development, Prana Therapies
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