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Palatin Announces Completion of Patient Enrollment in Phase 2 Study of Orally Administered Melanocortin Agonist PL8177 in Ulcerative Colitis

Palatin Announces Completion of Patient Enrollment in Phase 2 Study of Orally Administered Melanocortin Agonist PL8177 in Ulcerative Colitis

Palatin宣佈口服黑褐素激動劑PL8177用於潰瘍性結腸炎的2期研究已完成病人招募
PR Newswire ·  11/25 07:30
  • 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
  • 口服PL8177可能爲潰瘍性結腸炎患者在免疫抑制療法和類固醇治療之前提供一種安全、有效且耐受性好的治療選擇,這些療法存在顯著的安全性和耐受性問題
  • 前臨床數據表明,口服PL8177使患病的結腸趨向健康狀態,並消除了有害的炎症
  • 數據預計在2025年日曆年第一季度發佈

CRANBURY, N.J., Nov. 25, 2024 /PRNewswire/ -- Palatin Technologies, Inc. (NYSE American: PTN), a biopharmaceutical company developing first-in-class medicines based on molecules that modulate the activity of the melanocortin receptor system, today 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.

新澤西州克倫布里,2024年11月25日 /PRNewswire/ -- palatin technologies公司(紐交所美國: PTN)是一家基於調節黑色素皮質素受體系統活性的分子開發一類首創藥物的生物製藥公司,今天宣佈其PL8177的II期研究已完成患者入組,PL8177是一種強效的黑色素皮質素-1受體(MC1R)激動劑,針對潰瘍性結腸炎(UC)。該研究正在評估口服PL8177在活躍UC成年患者中的安全性、耐受性、療效、藥代動力學和生物標誌物。最後一位患者的訪視預計將在2025年第一季度進行,相關數據預計隨後發佈。

"UC is a chronic, often debilitating, and growing condition that currently affects more than one million people in the United States," stated Carl Spana, Ph.D., President and CEO of Palatin. "Prior data has demonstrated that oral PL8177 caused diseased colons to move towards a healthy state and resolved damaging inflammation. By resolving inflammation rather than blocking it, oral PL8177 may provide efficacy to patients without the safety and tolerability concerns of immunosuppressive therapies and steroid treatments, which have significant safety and tolerability concerns. Additionally, oral PL8177, as a preferable and more convenient once-daily pill, could provide an alternative to UC patients apprehensive about using injectable therapies."

「UC是一種慢性、通常是致殘的、且日益增長的控件,目前在美國影響超過一百萬人,」palatin的總裁兼首席執行官Carl Spana博士表示。「之前的數據表明,口服PL8177使患病的結腸趨向健康狀態,並消除了有害的炎症。通過消除炎症而不是阻斷它,口服PL8177可能爲患者提供療效,而無需擔心免疫抑制療法和類固醇治療的安全性和耐受性問題,這些療法具有顯著的安全性和耐受性問題。此外,口服PL8177作爲一種較佳的、方便的每日一次的藥丸,能夠爲對使用注射療法心存顧慮的UC患者提供替代選擇。」

"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."

「我們期待在下個季度分享這一試驗的結果,」Spana博士指出。「我們的目標是將UC項目進行外許可。目前,來自多個方面對我們的UC項目表現出顯著興趣,並正在進行持續討論。」

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

潰瘍性結腸炎是一種炎症性腸病(IBD),會導致消化道的炎症,並可能對結腸內壁造成損傷。患者常常經歷範圍廣泛的不可預測症狀,這些症狀影響他們的日常生活,如腹痛、血便和急需上廁所。疾病的進程因患者而異,在某些情況下可能導致手術或併發症,包括癌症或死亡。

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.

口服PL8177針對結腸上皮細胞腔面上的黑素皮質激素-1受體。在一期臨床研究中,口服配方成功地向結腸腔持續輸送PL8177,且沒有全身暴露。

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 via the identifier NCT05466890.

PL8177的二期研究是一項多中心、隨機、雙盲、安慰劑對照的自適應設計平行組研究,對成年潰瘍性結腸炎(UC)受試者進行8周每天一次(QD)的口服給藥。該研究最初設計爲在多個現場招募多達28名有活動性UC的成年受試者,計劃在完成12-16名受試者後進行中期分析。由於戰略決定在早期階段外許可UC項目,Palatin決定在招募到13名受試者後結束招募。療效評估和終點符合最新的FDA行業草案指導:潰瘍性結腸炎:開發治療藥物(2022年4月),包括主要療效終點測量,Mayo內鏡亞分數,該分數評估結腸粘膜中的疾病水平。額外的試驗信息,包括納入和排除標準,可以通過標識符NCT05466890找到。

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.

公司的二期UC試驗建立在一系列在右旋糖苷鈉(DSS)結腸炎模型中的口服PL8177劑量區間研究中呈現的臨床前數據基礎上,這些研究顯示了發炎結腸健康的顯著改善,包括結腸細胞相對增加,這對健康結腸是必要的。PL8177治療顯示出清晰的證據,表明通過將結腸巨噬細胞從促炎狀態重極化到促炎解決狀態,從而解決病理性炎症。

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.

關於黑色素皮質素受體激動劑
黑色素皮質激素受體("MCR")系統對炎症、免疫系統反應、新陳代謝、食物攝入和性功能等方面有影響。共有五種黑色素皮質激素受體,MC1R到MC5R。通過使用特異性受體激動劑對這些受體進行調節,激活受體功能,或使用特異性受體拮抗劑阻斷受體功能,可以產生具有醫學意義的藥理效應。

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.

眼睛(以及其他地方,例如胃腸道和腎臟)中的許多組織和免疫細胞表達黑色素皮質激素受體,這使我們有機會直接激活自然途徑來緩解疾病的炎症。

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.

關於PL8177
PL8177是一種合成的環狀七肽,在多種動物炎症性腸病模型中顯示出療效。PL8177是人類黑色素皮質素-1受體(MC1R)的強效選擇性激動劑,具有亞納摩爾親和力結合和EC50功能值。palatin technologies提供的數據表明,他們的PL8177口服制劑在人體的胃和小腸中得到了保護,能夠在長時間內送達結腸。此外,口服給予的PL8177在大鼠腸道炎症模型中對緩解炎症具有顯著影響。

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.

PL8177的口服制劑在潰瘍性結腸炎疾病模型中顯示出了多次、強效的療效。MC1R存在於結腸的上皮細胞和固有巨噬細胞上,這些細胞可以從結腸腔內獲得。口服給予的PL8177並未被系統性吸收。PL8177具有優秀療效的潛力,並且沒有安全性問題。

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 the United States are affected by ulcerative colitis, with over 350,000 diagnosed with moderate-to-severe disease.1 Existing treatments are not effective in a substantial portion of patients with moderate-to-severe ulcerative colitis, with certain severe cases resulting in surgical removal of the colon.

關於潰瘍性結腸炎
潰瘍性結腸炎是一種大腸(結腸)的慢性疾病,伴有炎症和潰瘍,可能導致顯著的腹痛、持續性腹瀉、食慾減退和其他症狀。估計在美國有125萬人受到潰瘍性結腸炎的影響,其中超過350,000人被診斷爲中度至重度疾病。現有治療對一部分中重度潰瘍性結腸炎患者效果不佳,某些重症病例甚至需要進行結腸切除手術。

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 and follow Palatin on Twitter at @PalatinTech.

關於Palatin
Palatin是一家生物製藥公司,開發基於調節黑皮質素受體系統活性的分子的一流醫藥品,針對存在重大醫療需求和市場潛力的疾病有具體的、以受體爲特定靶點的候選藥物。Palatin的策略是開發產品,然後與行業領袖簽訂營銷合作協議,以最大化其商業潛力。有關Palatin的更多信息,請訪問Palatin的網站 __________,並在Twitter上關注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.

前瞻性聲明
本新聞稿中的陳述不是歷史事實,包括關於Palatin Technologies, Inc.未來期望的陳述,如Palatin正在開發的產品、臨床試驗結果、監管機構(包括FDA)可能採取的行動、監管計劃、開發計劃、產品候選藥物的擬定適應症及產品候選藥物的市場潛力,均屬於"前瞻性陳述",在美國證券法第27A條和第21E條以及《1995年私人證券訴訟改革法案》所定義之意。Palatin希望這類前瞻性陳述受此項安全港的保護。這樣的前瞻性陳述涉及已知和未知的風險、不確定性和其他因素,這些因素可能導致Palatin的實際結果與其歷史結果或任何前瞻性陳述所表達或暗示的結果有實質不同。 Palatin的實際結果可能因臨床試驗結果、FDA和其他監管方的行動以及獲得監管批准的需求,Palatin籌集技術的能力以及建立併成功完成臨床試驗所需的時間和成本、競爭製藥、生物製藥和生物技術公司開發的產品、Palatin產品的商業接受度以及Palatin的其它因素而與前瞻性陳述中討論的結果有實質不同,這些因素在Palatin定期向美國證券交易委員會提交的文件中有所討論。 Palatin不負責更新在本新聞稿日期之後發生的事件。

Palatin Technologies is a registered trademark of Palatin Technologies, Inc.

Palatin Technologies是Palatin Technologies, Inc.的註冊商標。

1 Lewis JD, Parlett LE, Jonsson Funk ML, et al. Incidence, prevalence, and racial and ethnic distribution of inflammatory bowel disease in the United States. Gastroenterology. 2023;165(5). doi:10.1053/j.gastro.2023.07.003.
2 The Facts about Inflammatory Bowel Diseases. Crohn's & Colitis Foundation of America. 2014. Available at: . Accessed June 2024.
3 Ulcerative colitis. Mayo Clinic. 2022. Available at: . 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.

1 Lewis JD, Parlett LE, Jonsson Funk ML, 等人在美國炎症性腸病的發病率、流行率以及種族和民族分佈。胃腸病學。2023;165(5). doi:10.1053/j.gastro.2023.07.003。
2 關於炎症性腸病的事實。克羅恩病與結腸炎基金會。2014年。可在:。訪問日期:2024年6月。
3 潰瘍性結腸炎。梅奧診所。2022年。可在:。訪問日期:2024年6月。
4 Monstad, I, Hovde O, Solberg IC, A Moum b. 潰瘍性結腸炎的臨床過程和預後:基於人群的觀察研究結果。胃腸病學年鑑。2014;27(2):95-104。

SOURCE Palatin Technologies, Inc.

資料來源:Palatin Technologies,Inc。

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