Palatin Announces Completion of Patient Enrollment in Phase 2 Study of Orally Administered Melanocortin Agonist PL8177 in Ulcerative Colitis
Palatin Technologies (NYSE American: PTN) has completed patient enrollment in its Phase 2 study of PL8177, an oral melanocortin-1 receptor agonist, for ulcerative colitis treatment. The study involves 13 subjects and evaluates safety, efficacy, and other parameters of the drug. Topline data is expected in Q1 2025. PL8177, delivered as a once-daily pill, targets inflammation without immunosuppression, potentially offering a safer alternative to current treatments. The company aims to out-license the UC program, noting significant interest from multiple parties. Preclinical data showed PL8177's effectiveness in improving colon health and resolving inflammation.
Palatin Technologies (NYSE American: PTN) ha completato l'arruolamento dei pazienti nel suo studio di Fase 2 su PL8177, un agonista orale del recettore melanocortin-1, per il trattamento della colite ulcerosa. Lo studio coinvolge 13 soggetti e valuta la sicurezza, l'efficacia e altri parametri del farmaco. I dati preliminari sono attesi nel primo trimestre del 2025. PL8177, somministrato come pillola giornaliera, mira a ridurre l'infiammazione senza immunosoppressione, offrendo potenzialmente un'alternativa più sicura ai trattamenti attuali. L'azienda punta a concedere in licenza il programma UC, notando un interesse significativo da parte di più parti. I dati preclinici hanno dimostrato l'efficacia di PL8177 nel migliorare la salute del colon e nell'eliminazione dell'infiammazione.
Palatin Technologies (NYSE American: PTN) ha completado la reclutamiento de pacientes en su estudio de Fase 2 de PL8177, un agonista oral del receptor melanocortina-1, para el tratamiento de la colitis ulcerosa. El estudio involucra a 13 sujetos y evalúa la seguridad, eficacia y otros parámetros del medicamento. Se esperan datos preliminares en el primer trimestre de 2025. PL8177, administrado como una pastilla una vez al día, se dirige a la inflamación sin causar inmunosupresión, lo que podría ofrecer una alternativa más segura a los tratamientos actuales. La empresa planea licenciar el programa de colitis ulcerosa, señalando un interés significativo de múltiples partes. Los datos preclínicos mostraron la efectividad de PL8177 para mejorar la salud del colon y resolver la inflamación.
팔라틴 테크놀로지스 (NYSE American: PTN)는 궤양성 대장염 치료를 위한 경구용 멜라노코르틴-1 수용체 작용제 PL8177의 2상 연구에서 환자 모집을 완료했습니다. 이 연구는 13명의 참가자를 포함하며, 약물의 안전성, 효능 및 기타 파라미터를 평가합니다. 1분기 2025년에 주요 데이터가 예상됩니다. 하루에 한 번 복용하는 PL8177은 면역억제 없이 염증을 표적으로 하여 현재 치료법보다 안전한 대안을 제공할 수 있습니다. 이 회사는 UC 프로그램의 라이센스를 부여할 계획이며, 여러 당사자로부터 상당한 관심을 받고 있습니다. 전임상 데이터는 PL8177이 대장 건강을 개선하고 염증을 해결하는 데 효과적임을 보여주었습니다.
Palatin Technologies (NYSE American: PTN) a finalisé le recrutement des patients pour son étude de Phase 2 sur PL8177, un agoniste oral du récepteur mélanocortine-1, pour le traitement de la colite ulcéreuse. L'étude implique 13 sujets et évalue la sécurité, l'efficacité et d'autres paramètres du médicament. Les données préliminaires sont attendues au premier trimestre 2025. PL8177, administré sous forme de pilule à prendre une fois par jour, cible l'inflammation sans immunosuppression, offrant potentiellement une alternative plus sûre aux traitements actuels. L'entreprise vise à octroyer une licence pour le programme de colite ulcéreuse, notant un intérêt significatif de plusieurs parties. Les données précliniques ont montré l'efficacité de PL8177 pour améliorer la santé du côlon et résoudre l'inflammation.
Palatin Technologies (NYSE American: PTN) hat die Patientenrekrutierung in seiner Phase-2-Studie zu PL8177, einem oralen Agonisten des Melanocortin-1-Rezeptors, zur Behandlung von Colitis ulcerosa abgeschlossen. Die Studie umfasst 13 Probanden und bewertet die Sicherheit, Wirksamkeit und andere Parameter des Medikaments. Die vorläufigen Daten werden im ersten Quartal 2025 erwartet. PL8177, das als einmal täglich einzunehmende Tablette verabreicht wird, zielt auf Entzündungen ab, ohne das Immunsystem zu unterdrücken, was potenziell eine sicherere Alternative zu den derzeitigen Behandlungen bieten könnte. Das Unternehmen plant, das UC-Programm zu lizenzieren, wobei ein erhebliches Interesse seitens mehrerer Parteien festgestellt wurde. Vorklinische Daten zeigten die Wirksamkeit von PL8177 bei der Verbesserung der Dickdarmgesundheit und der Behebung von Entzündungen.
- Completed enrollment in Phase 2 study ahead of Q1 2025 data readout
- Significant interest from multiple parties for potential out-licensing
- Preclinical data showed positive results in colon health improvement
- Drug offers potential advantages over current treatments (oral administration, no immunosuppression)
- Phase 1 demonstrated successful colon delivery without systemic exposure
- Reduced enrollment from planned 28 to 13 subjects due to early out-licensing strategy
- Results and potential commercialization still pending clinical validation
Insights
The completion of patient enrollment in Palatin's Phase 2 study for PL8177 in ulcerative colitis represents a significant milestone. The study's focus on 13 enrolled patients with topline data expected in Q1 2025 could provide important insights into this novel treatment approach. The oral melanocortin agonist's unique mechanism targeting MC1R receptors, with preclinical data showing inflammation resolution rather than suppression, differentiates it from current treatments.
The strategic decision to end enrollment early and pursue out-licensing opportunities suggests confidence in the existing data. The market opportunity is substantial, with over 350,000 patients diagnosed with moderate-to-severe UC in the US alone. If successful, PL8177's oral administration route and potentially better safety profile compared to immunosuppressive therapies could capture significant market share.
The announcement carries strategic importance for Palatin's business trajectory. With a market cap of just
The company's decision to expedite out-licensing by limiting enrollment to 13 patients indicates a focus on capital efficiency and faster value realization. This approach could accelerate partnership negotiations while preserving resources, though it may impact the study's statistical power.
- Oral PL8177 may provide a safe, effective, and tolerable treatment option for ulcerative colitis patients prior to immunosuppressive therapies and steroid treatments, which have significant safety and tolerability concerns
- Preclinical data demonstrated that oral PL8177 caused diseased colons to move towards a healthy state and to resolve damaging inflammation
- Data expected 1Q calendar year 2025
"UC is a chronic, often debilitating, and growing condition that currently affects more than one million people in
"We look forward to sharing the results of this trial next quarter," noted Dr. Spana. "Our objective is to out-license the UC program. At this stage, there has been significant interest in and ongoing discussions around our UC program from multiple parties."
Ulcerative colitis is a form of inflammatory bowel disease (IBD) that causes inflammation in the digestive tract and can result in damage to the colon lining.2 Patients often experience a range of unpredictable symptoms that impact their daily lives, such as abdominal pain, bloody stool and urgency to use the bathroom.2,3 The disease course varies between patients, and in some cases can lead to surgery or complications, including cancer or death.3,4
Orally administered PL8177 targets melanocortin-1 receptors on the luminal surface of colon epithelial cells. In a Phase 1 clinical study, the oral formulation successfully demonstrated sustained delivery of PL8177 to the lumen of the colon with no systemic exposure.
The Phase 2 PL8177 study is a multi-center, randomized, double-blind, placebo-controlled, adaptive design, parallel group of PL8177, with once daily (QD) oral dosing in adult UC subjects for 8 weeks. The study was originally designed to enroll up to 28 adult subjects with active UC from multiple sites, with an interim analysis planned after completion of 12-16 subjects. Due to the strategic decision to out-license the UC program at an earlier stage, Palatin decided to end enrollment after 13 subjects. The efficacy evaluations and endpoints are in line with the latest FDA Draft Guidance for Industry: Ulcerative Colitis: Developing Drugs for Treatment (April 2022), including the primary efficacy endpoint measurement, the Mayo Endoscopic Subscore, which evaluates the level of disease in the colon mucosa. Additional trial information, including inclusion and exclusion criteria, can be found at https://clinicaltrials.gov/ via the identifier NCT05466890.
The Company's Phase 2 trial in UC builds upon presented preclinical data from a series of oral PL8177 dose-ranging studies in the dextran sulfate sodium (DSS) colon inflammation model, which 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.
About Melanocortin Receptor Agonists
The melanocortin receptor ("MCR") system has effects on inflammation, immune system responses, metabolism, food intake, and sexual function. There are five melanocortin receptors, MC1R through MC5R. Modulation of these receptors, through use of receptor-specific agonists, which activate receptor function, or receptor-specific antagonists, which block receptor function, can have medically significant pharmacological effects.
Many tissues and immune cells located in the eye (and other places, for example the gut and kidney) express melanocortin receptors, empowering our opportunity to directly activate natural pathways to resolve disease inflammation.
About PL8177
PL8177 is a synthetic cyclic heptapeptide with demonstrated efficacy in multiple animal inflammatory bowel disease models. PL8177 is a potent, selective agonist at the human melanocortin-1 receptor (MC1R), with sub-nanomolar affinity binding and EC50 functional values. Palatin data demonstrates that their oral formulation of PL8177 was protected from degradation in the stomach and small intestine of humans and delivered to the colon over an extended period. In addition, orally administered PL8177 had a significant effect on resolving inflammation in a rat bowel inflammation model.
PL8177 in oral formulations has demonstrated repeated, robust efficacy in ulcerative colitis disease models. MC1R is found on epithelial cells and resident macrophages of the colon which are accessible from the lumen of the colon. Orally administered PL8177 is not systemically absorbed. PL8177 has the potential for excellent efficacy without safety concerns.
About Ulcerative Colitis
Ulcerative colitis is a chronic disease of the large intestine (colon), with inflammation and ulcerations that can cause significant abdominal pain, persistent diarrhea, loss of appetite and other symptoms. An estimated 1.25 million individuals in
About Palatin
Palatin is a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor systems, with targeted, receptor-specific product candidates for the treatment of diseases with significant unmet medical need and commercial potential. Palatin's strategy is to develop products and then form marketing collaborations with industry leaders to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin's website at www.Palatin.com and follow Palatin on Twitter at @PalatinTech.
Forward-looking Statements
Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about Palatin products in development, clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates, and market potential for product candidates are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin intends that such forward-looking statements be subject to the safe harbors created thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin's actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin's actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and other regulatory and the need for regulatory approvals, Palatin's ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin's products, and other factors discussed in Palatin's periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating events that occur after the date of this press release.
Palatin Technologies® is a registered trademark of Palatin Technologies, Inc.
1 Lewis JD, Parlett LE, Jonsson Funk ML, et al. Incidence, prevalence, and racial and ethnic distribution of inflammatory bowel disease in
2 The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf. Accessed June 2024.
3 Ulcerative colitis. Mayo Clinic. 2022. Available at: https://www.mayoclinic.org/diseases-conditions/ulcerative-colitis/symptoms-causes/syc-20353326. Accessed June 2024.
4 Monstad, I, Hovde O, Solberg IC, A Moum B. Clinical course and prognosis in ulcerative colitis: results from population-based and observational studies. Ann Gastroenterol. 2014;27(2):95-104.
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FAQ
When will Palatin (PTN) release Phase 2 results for PL8177 in ulcerative colitis?
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What is the current status of Palatin's (PTN) PL8177 out-licensing efforts?
