Relief Therapeutics Completes Clinical Phase in RLF-OD032 Proof-of-Concept Study; Topline Results Expected in October 2024
Relief Therapeutics Completes Clinical Phase in RLF-OD032 Proof-of-Concept Study; Topline Results Expected in October 2024
GENEVA, SWITZERLAND / ACCESSWIRE / September 18, 2024 / RELIEF THERAPEUTICS Holding SA (SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY ) (Relief, or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that it has completed dosing in its proof-of-concept clinical study of RLF-OD032 for the treatment of phenylketonuria (PKU), a rare inherited disorder affecting phenylalanine metabolism.
瑞士日內瓦/ ACCESSWIRE / 2024年9月18日 / 緩解治療控股公司(SIX:RLF)(OTCQB:RLFTF)(OTCQB:RLFTY)(下稱緩解,或公司)是一家專注於爲特定專業、未滿足和罕見疾病提供創新治療選擇的生物製藥公司。今天宣佈,它已完成了用於苯丙酮尿症(PKU)治療的RLF-OD032概念驗證臨床研究的給藥。PKU是一種罕見的遺傳性疾病,影響苯丙氨酸代謝。
The primary objectives of the study include the comparison of RLF-OD032 to a currently marketed sapropterin dihydrochloride product, with a focus on bioavailability under fed and fasting conditions. The Company expects topline results in October 2024. These results will inform further development of RLF-OD032 toward a pivotal trial and potential regulatory submission under the 505(b)(2) NDA pathway in the United States.
該研究的主要目標包括將RLF-OD032與目前市場銷售的羥異丙酮二鹽酸鹽產品進行比較,重點關注飲食和禁食條件下的生物利用度。公司預計將在2024年10月公佈首要結果。這些結果將爲RLF-OD032的進一步開發提供信息,以備進行至關重要的試驗和在美國進行可能的505(b)(2) NDA路徑下的監管提交。
RLF-OD032, an innovative and highly concentrated liquid formulation of sapropterin dihydrochloride, is designed to lower blood phenylalanine in adult and pediatric PKU patients. It offers a more patient-friendly solution by significantly reducing the volume of medication required compared to current formulations. This advancement aims to enhance compliance, particularly among pediatric patients, who often struggle with the high volumes associated with existing sapropterin treatments. If approved, RLF-OD032 would be the first and only portable, ready-to-use liquid formulation of sapropterin dihydrochloride.
RLF-OD032是羥異丙酮二鹽酸鹽的一種創新和高濃度液體制劑,旨在降低成人和兒童PKU患者的血液苯丙氨酸含量。與當前的製劑相比,它能夠顯著減少所需藥物的用量,爲患者提供更方便的解決方案。這一進展旨在提高依從性,特別是在兒童患者中,他們往往難以應對現有羥異丙酮治療的大量用量。如果獲批,RLF-OD032將成爲第一款也是唯一一款便攜式、即用型的羥異丙酮二鹽酸鹽液體制劑。
ABOUT RELIEF
Relief is a commercial-stage biopharmaceutical company committed to advancing treatment paradigms and delivering improvements in efficacy, safety, and convenience to benefit the lives of patients living with select specialty and rare diseases. Relief's portfolio offers a balanced mix of marketed, revenue-generating products, proprietary, globally patented TEHCLO and Physiomimic platform technologies and a targeted clinical development pipeline consisting of risk-mitigated assets focused in three core therapeutic areas: rare skin diseases, rare metabolic disorders, and rare respiratory diseases. In addition, Relief is commercializing several legacy products via licensing and distribution partners. Headquartered in Geneva, Relief is listed on the SIX Swiss Exchange under the symbol RLF and quoted in the U.S. on OTCQB under the symbols RLFTF and RLFTY. For more information, visit .
關於救濟
Relief是一家商業化階段的生物製藥公司,致力於推進治療範式,提高治療效果,安全性和便利性,從而造福於患有特定專業和罕見疾病的患者。 Relief的組合產品提供了平衡的市場,產生收入,專有,全球專利TEHCLO和Physiomimic平台技術以及定向臨床開發管道,包括三個核心治療領域:罕見的皮膚病,罕見的代謝性疾病和罕見的呼吸道疾病。此外,Relief通過授權和分銷合作伙伴商業化了數種傳統產品。 總部設在日內瓦,Relief在SIX Swiss Exchange上市,代碼爲RLF,在OTCQb上引用代碼爲RLFTF和RLFTY。 有關更多信息,訪問。
CONTACT :
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
Chief Financial Officer
contact@relieftherapeutics.com
聯繫方式 :
RELIEF THERAPEUTICS Holding SA
Jeremy Meinen
致富金融(臨時代碼)官
contact@relieftherapeutics.com
DISCLAIMER
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties, including its ability to achieve its corporate, development and commercial goals, and other factors which could cause the actual results, financial condition, performance or achievements of Relief to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. A number of factors, including those described in Relief's filings with the SIX Swiss Exchange and the U.S. Securities and Exchange Commission (SEC), could adversely affect Relief. Copies of Relief's filings with the SEC are available on the SEC EDGAR database at www.sec.gov . Relief does not undertake any obligation to update the information contained herein, which speaks only as of this date.
免責聲明
本新聞稿包含前瞻性陳述。 前瞻性陳述涉及已知和未知的風險,不確定性,包括其實現其公司,開發和商業目標的能力,以及可能導致Relief的實際結果,財務狀況,績效或成就與任何未來結果,績效或預期的前瞻性陳述有實質不同的因素。諸如上述因素的數量,在Relief與美國證券交易委員會(SEC)的SIX Swiss Exchange和SEC的文件中描述,可能會對Relief產生不利影響。 Relief的文件備份可在SEC EDGAR數據庫中查詢www.sec.gov。 Relief不承擔更新此處所含信息的任何義務,該信息僅於本日期有效。
SOURCE: Relief Therapeutics Holdings AG
SOURCE:Relief Therapeutics Holdings AG
譯文內容由第三人軟體翻譯。