PL8177 / Palatin Technologies - LARVOL DELTA

Safety, Tolerability, and Efficacy of PL8177 in Adults With Active Ulcerative Colitis: Results From a Phase 2a, Randomized, Placebo-Controlled Study (ACG 2025) - "A total of 64 participants were screened and 12 participants (PL8177, n=9; placebo, n=3) were randomized. Mean age was 47.1 years (range, 24-75) and 50.0% were female. A total of 12 AEs in 4 participants and 6 AEs in 1 participant were reported in PL8177 and placebo groups, respectively."

Clinical • P2a data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Palatin Announces Positive Topline Results from Phase 2 Ulcerative Colitis (UC) Study of Oral Melanocortin-1 Receptor Agonist PL8177 (PRNewswire) - P2 | N=16 | NCT05466890 | Sponsor: Palatin Technologies, Inc | "Palatin Technologies, Inc...announced positive topline results from its Phase 2 study of PL8177, a selective melanocortin-1 receptor (MC1R) agonist, in patients with active ulcerative colitis (UC)....Clinical remission was achieved in 33% (3 of 9) of PL8177-treated patients versus 0% (0 of 3) on placebo. Clinical remission is defined per FDA Guidance (April 2022) as a modified Mayo Score (mMS) of 0 to 2, including the following three components: rectal bleeding subscore = 0, stool frequency subscore = 0 or 1, and endoscopy subscore = 0 or 1. Clinical response (statistically significant) was demonstrated in 78% (7 of 9) of PL8177-treated patients versus 33% (1 of 3) on placebo (p<0.005)....Additional findings are expected to be shared at an upcoming scientific conference."

P2 data • Ulcerative Colitis

PL8177-205: Phase 2a to Evaluate PL-8177 in Subjects with Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2 | N=16 | Active, not recruiting | Sponsor: Palatin Technologies, Inc | Recruiting ➔ Active, not recruiting | N=28 ➔ 16 | Trial completion date: Aug 2024 ➔ Mar 2025 | Trial primary completion date: Apr 2024 ➔ Feb 2025

Biomarker • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Dry eye disease (DED) and other ocular programs, ulcerative colitis (UC), and diabetic nephropathy programs (PRNewswire) - "Program specific licensing/collaboration and spinout activities ongoing with multiple deals targeted for calendar year 2025...DED: Concluded positive Type C meeting with the FDA and reached agreement on sign and symptom endpoints for remaining two Phase 3 pivotal trial protocols, with patient enrollment prepared to commence 1H calendar year 2025; UC: Report topline results from our Phase 2 clinical study of PL8177 oral formulation for the treatment of UC later this quarter."

Licensing / partnership • New P3 trial • P2 data • Diabetic Nephropathy • Dry Eye Disease • Ulcerative Colitis

Palatin Announces Completion of Patient Enrollment in Phase 2 Study of Orally Administered Melanocortin Agonist PL8177 in Ulcerative Colitis (PRNewswire) - "Palatin Technologies, Inc...announced the completion of enrollment in its Phase 2 Study of PL8177, a potent melanocortin-1 receptor (MC1R) agonist, in ulcerative colitis (UC). The study is evaluating the safety, tolerability, efficacy, pharmacokinetics, and biomarkers of orally administered PL8177 in adult patients with active UC. The last patient visit is expected to occur in the first quarter of 2025, with topline data expected shortly thereafter."

Enrollment closed • P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Palatin Provides Update on Clinical Programs, Strategic Priorities, and Anticipated Milestones (PRNewswire) - "Phase 2 PL8177 oral formulation for the treatment of ulcerative colitis (UC): Potential collaboration discussions ongoing; Interim analysis expected in 4Q calendar year 2024; Topline results anticipated 1Q calendar year 2025."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Palatin Reports Third Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update (PRNewswire) - "Phase 2 PL8177 oral formulation for the treatment of ulcerative colitis (UC): Interim assessment expected in the second quarter of calendar year 2024; Topline data readout expected in the second half of calendar year 2024."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Melanocortin-1 Receptor is Required for the Survival of Retinal Ganglion Cells after Ischemia/Reperfusion Injury (ARVO 2024) - "The analogs were Peptide 1 (P1), PL-8177 an MC1r agonist; P2, MT-II an MC1r and MC3r agonist; P3, PL-9588 an MC1r and MC5r agonist; and P4, PG-901 an MC5r agonist but MC3r antagonist... Agonizing the MC1r is necessary for melanocortin-mediated maintenance of retinal structure and survival of RGCs in eyes with I/R"

Diabetic Retinopathy • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • FAP • GFAP

Palatin Reports Second Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update (PRNewswire) - "PL8177 Phase 2 oral formulation for the treatment of ulcerative colitis (UC): Interim assessment expected in the second quarter of calendar year 2024; Topline data readout expected in the second half of calendar year 2024."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A NEW APPROACH FOR TREATMENT OF ULCERATIVE COLITIS: A MELANOCORTIN RECEPTOR AGONIST PL8177 (CCCongress 2024) - "PL8177 50 μg showed a significant (P<0.05) improvement in colon weight (53% reduction), stool consistency, and fecal occult blood score vs vehicle, and there was significant improvement in the total colitis index for the PL8177 100-μg group vs vehicle. All PL8177 cohorts showed greater improvement in the total colitis index than mesalazine. Mesalazine produced a marked reduction in colon length, but only moderate improvement (35%) in colon weight."

Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis • SMAD2

Palatin Provides Corporate Update and Highlights Strategic Priorities for Calendar Year 2024 (PRNewswire) - "PL8177 oral melanocortin agonist Phase 2 study for the treatment of UC: Interim assessment targeted for the first quarter of calendar year 2024. Topline data readout is expected in the second quarter of calendar year 2024."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PL8177-205: Phase 2a To Evaluate PL-8177 in Subjects With Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2 | N=28 | Recruiting | Sponsor: Palatin Technologies, Inc | Phase classification: P2a ➔ P2 | Trial completion date: May 2024 ➔ Aug 2024 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Biomarker • Phase classification • Trial completion date • Trial primary completion date • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Palatin Reports First Quarter Fiscal Year 2024 Financial Results and Provides Corporate Update (PRNewswire) - "Phase 2 Clinical Study of Oral PL8177 in Patients with Ulcerative Colitis; Interim Analysis Targeted for 1Q Calendar Year 2024; Topline Results Currently Expected in 2Q Calendar Year 2024."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Cellular and Molecular Impact of the Melanocortin Receptor Agonist PL8177 in Dextran Sulfate Sodium-Induced Colitis in Rats (ACG 2023) - "PL8177 50 μg showed a significant ( P < 0.05) improvement in colon weight (53% reduction), stool consistency, and fecal occult blood score vs vehicle, and there was significant improvement in the total colitis index for the PL8177 100-μg group vs vehicle. All PL8177 cohorts showed greater improvement in the total colitis index than mesalazine. Mesalazine produced a marked reduction in colon length, but only moderate improvement (35%) in colon weight."

Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

Palatin Presents Data at the United European Gastroenterology Week 2023 Conference On PL8177 Ulcerative Colitis Treatment (PRNewswire) - "Palatin Technologies, Inc...announced the presentation of a poster...at the United European Gastroenterology Week (UEG) being held October 14-17 2023 in Copenhagen, Denmark. Lead author Paul S. Kayne, Ph.D., Vice President Biological Sciences at Palatin Technologies, presented the poster...Compared to vehicle and the positive control mesalazine, PL8177 showed significant improvements in inflamed colon health, including relative increases in colon cells needed for a healthy colon. PL8177 treatment showed clear evidence of resolving pathological inflammation by repolarizing colon macrophages from a pro-inflammatory to a pro-inflammation resolving state."

Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Palatin Reports Fourth Quarter and Fiscal Year Ended 2023 Financial Results and Provides Corporate Update (PRNewswire) - "Phase 2 Clinical Study of Oral PL8177 in Patients with Ulcerative Colitis; Interim Analysis Targeted for 1Q Calendar Year 2024; Topline Results Currently Expected First Half Calendar Year 2024."

P2a data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

CELLULAR AND MOLECULAR IMPACT OF THE MELANOCORTIN RECEPTOR AGONIST PL8177 IN DEXTRAN SULFATE SODIUM–INDUCED COLITIS IN RATS (UEGW 2023) - "In a rat model, oral PL8177 treatment of colonic inflammation showed significant improvement in anatomical markers of colitis vs the vehicle and mesalazine control groups, supporting the aim of treating inflammatory bowel disease (IBD) in humans. Transcriptomics and proteomics data show that oral PL8177 treatment causes diseased colons to move toward the healthy state and to resolve inflammation. Resolving inflammation—rather than blocking it—provides the possibility of efficacy coupled with safety in treating IBD."

Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease

PL8177-205: Phase 2a To Evaluate PL-8177 in Subjects With Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2a | N=28 | Recruiting | Sponsor: Palatin Technologies, Inc | Trial completion date: Oct 2023 ➔ May 2024 | Trial primary completion date: Jul 2023 ➔ Dec 2023

Biomarker • Trial completion date • Trial primary completion date • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Palatin Reports Third Quarter Fiscal Year 2023 Financial Results and Provides Corporate Update (PRNewswire) - "Phase 2 Clinical Study of Oral PL8177 in Patients with Ulcerative Colitis: Interim Analysis Targeted for Second Half Calendar Year 2023. Topline Results Currently Expected First Half Calendar Year 2024."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

EFFICACY OF THE MELANOCORTIN RECEPTOR AGONIST PL8177 AS A POTENTIAL THERAPY FOR GASTROINTESTINAL (GI) INFLAMMATORY DISEASES (DDW 2023) - "Conclusion Collectively, these findings support further development of PL8177 as a treatment option for GI inflammatory diseases in humans. This will be further examined in the phase 2 trial in humans with UC."

Clinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Palatin Presents PL8177 Ulcerative Colitis Data at Digestive Disease Week Annual Conference (PRNewswire) - "Palatin Technologies, Inc...announced the presentation of the poster...at the Digestive Disease Week annual meeting May 6-9, 2023 in Chicago, Illinois. The poster was presented by John Dodd, Ph.D., Senior Vice President of Preclinical Research at Palatin....In preclinical studies in rat models of ulcerative colitis, oral PL8177 was found to be efficacious in reducing colonic damage and inflammation. In rats and dogs, data showed that oral PL8177 is released in the lower GI tract where it can exert its effect on inflammation....A phase 2 study, PL8177-205, is currently enrolling patients. An interim assessment and topline data is anticipated in the second half of 2023."

P2 data • Preclinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A novel oral formulation of the melanocortin-1 receptor agonist PL8177 resolves inflammation in preclinical studies of inflammatory bowel disease and is gut restricted in rats, dogs, and humans. (PubMed, Front Immunol) - "This suggests that the parent drug [C]-PL8177 was released from the polymer formulation and metabolized within the GI tract, where it would be expected to exert its effect. Collectively, these findings support further research into the oral formulation of PL8177 as a possible therapeutic for GI inflammatory diseases in humans."

Journal • Preclinical • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammation • Inflammatory Bowel Disease • Ulcerative Colitis

Frontiers in Immunology Publishes Pre-Clinical Study of Palatin's Oral Formulation of PL8177 Demonstrating Therapeutic Effects in Inflammatory Bowel Disease (PRNewswire) - "Palatin research scientists conducted multiple studies in rat models of inflammatory bowel disease to assess the immunopharmacology of PL8177. Key findings included maintenance of intact colon structure and barrier, reduced immune cell infiltration, and increased enterocytes with PL8177 treatment. Genomic data show that oral PL8177 treatment causes relative cell populations and key gene expression levels to move closer to healthy controls. Compared with vehicle, PL8177 treated colon samples show positive effects on immune marker genes and diverse, well known immune-related pathways."

Preclinical • Immunology • Inflammation • Inflammatory Bowel Disease

Palatin Reports Second Quarter Fiscal Year 2023 Financial Results and Provides Corporate Update (PRNewswire) - "Phase 2 Clinical Study of Oral PL8177 in Patients with Ulcerative Colitis Commenced...Planned Interim Analysis Targeted for First Half Calendar Year 2023; Topline Results Currently Expected Second Half Calendar Year 2023."

P2 data • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

PL8177-205: Phase 2a To Evaluate PL-8177 in Subjects With Active Ulcerative Colitis (UC) (clinicaltrials.gov) - P2a | N=28 | Recruiting | Sponsor: Palatin Technologies, Inc | Trial completion date: Jun 2023 ➔ Oct 2023 | Trial primary completion date: Mar 2023 ➔ Jul 2023

Biomarker • Trial completion date • Trial primary completion date • Colon Cancer • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis