Bremelanotide + PDE5i

Sept. 9, 2024: Palatin Technologies, Inc. (NYSE: PTN) provided a clinical pipeline and milestone update across multiple programs.

PL9643 (dry eye disease): Following a positive FDA Type C meeting, Palatin said the FDA confirmed/agreed on Phase 3 protocols and sign/symptom endpoints for the remaining pivotal studies (MELODY-2 and MELODY-3). Patient enrollment is targeted to start in 4Q 2024, with topline results anticipated in 4Q 2025 and a potential NDA submission in 1H 2026. The prior Phase 3 MELODY-1 study is described as successful, meeting the co-primary symptom endpoint of pain (p<0.025) and multiple secondary symptom and sign endpoints; safety/tolerability was described as excellent. Collaboration/funding discussions are ongoing.

Obesity: A Phase 2 study co-administering bremelanotide (MC4R agonist) with tirzepatide (GLP-1) has begun dosing (3Q 2024); topline results are expected in 1H 2025 (ClinicalTrials.gov NCT06565611). IND-enabling work for a novel long-acting MC4R agonist is expected in 4Q 2024, with IND filing anticipated in 2H 2025.

Male sexual dysfunction/ED: A bremelanotide + PDE5 inhibitor co-formulation program is planned; PK study start is expected in 1Q 2025, Phase 3 recruitment in 2H 2025, and topline results targeted for 1H 2026.

Ulcerative colitis: Phase 2 oral PL8177 interim analysis is expected 4Q 2024 and topline results 1Q 2025 (NCT05466890); partnering discussions ongoing.

Diabetic nephropathy: Phase 2 BREAKOUT (BMT 701; bremelanotide) topline results are expected in 4Q 2024 (NCT05709444).

Vyleesi (bremelanotide injection)/HSDD: Asset sale to Cosette closed in Dec. 2023 for up to $171M; Palatin retained bremelanotide rights for obesity and ED.