SCYNEXIS Initiates Dosing in Phase 1 Trial of SCY-247, a Second-Generation Fungerp Candidate for Invasive Fungal Infections
SCYNEXIS Initiates Dosing in Phase 1 Trial of SCY-247, a Second-Generation Fungerp Candidate for Invasive Fungal Infections
JERSEY CITY, N.J., Dec. 18, 2024 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant infections, today announced that it has completed the dosing of the first cohort of subjects in its Phase 1 trial of SCY-247, the Company's second-generation triterpenoid antifungal in development for the treatment of severe invasive fungal infections.
新泽西州泽西市,2024年12月18日 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (纳斯达克: SCYX),一家在生物技术领域开创性开发创新药物以克服和预防难治性和药物抗性感染的公司,今天宣布其SCY-247的第一组受试者已完成给药,该药是公司正在开发的第二代三萜类抗真菌药物,用于严重侵袭性真菌感染的治疗。
"We are pleased to advance our potent, second-generation fungerp candidate SCY-247 into the clinic in a Phase 1 study," said David Angulo, M.D., President and Chief Executive Officer. "SCY-247 has consistently shown promising results in preclinical models of several invasive fungal diseases and has activity against many of the fungi on the World Health Organization (WHO) fungal priority pathogen list. With the vulnerable population at risk of invasive fungal diseases increasing, their high mortality rates, and the growing concern for drug resistance, there is an urgent need for new therapies. We believe SCY-247 has the potential to address critical unmet needs in this space, and progressing this novel antifungal represents a very significant milestone toward our goal of delivering a new weapon to fight serious fungal infections."
“我们很高兴将我们强大的第二代fungerp候选药物SCY-247推进到临床阶段的第1期研究中,”总裁兼首席执行官David Angulo万.D.说。“SCY-247在多种侵袭性真菌疾病的临床前模型中始终显示出有希望的结果,并对世界卫生组织(WHO)真菌优先病原体名单上的许多真菌具有活性。随着易感人群面临侵袭性真菌疾病的风险增加,其高死亡率以及对药物抗性的日益担忧,对于新疗法的需求迫在眉睫。我们相信SCY-247有潜力满足这一领域的关键未满足需求,推进这一新型抗真菌药物代表着朝着向严重真菌感染提供新武器的目标迈出的重要里程碑。”
The Phase 1 trial is a randomized, double-blind, placebo-controlled study of single and multiple ascending doses of oral SCY-247 in approximately 100 healthy subjects. The primary endpoint is safety and tolerability, and the secondary endpoint is pharmacokinetics.
第1期试验是一项随机、双盲、安慰剂对照的研究,涉及约100名健康受试者的单次和多次递增剂量的口服SCY-247。主要终点是安全性和耐受性,次要终点是药物药代动力学。
About SCY-247
关于SCY-247
SCY-247 is a second-generation antifungal compound, from a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids (fungerps), being developed to address the significant threat posed by antimicrobial resistance (AMR) in systemic fungal diseases with high mortality. The triterpenoid class of antifungals represents the first new class of antifungal compounds approved since 2001. These agents combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. SCY-247 is in Phase 1 of development and has demonstrated in vitro and in vivo broad-spectrum antifungal activity, including against multidrug resistant fungal pathogens. SCYNEXIS anticipates that the U.S. Food and Drug Administration (FDA) may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the IV and oral formulations of SCY-247.
SCY-247 is a second-generation antifungal compound, from a novel class of structurally-distinct glucan synthase inhibitors, triterpenoids (fungerps), being developed to address the significant threat posed by antimicrobial resistance (AMR) in systemic fungal diseases with high mortality. The triterpenoid class of antifungals represents the first new class of antifungal compounds approved since 2001. These agents combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. SCY-247 is in Phase 1 of development and has demonstrated in vitro and in vivo broad-spectrum antifungal activity, including against multidrug resistant fungal pathogens. SCYNEXIS anticipates that the U.S. Food and Drug Administration (FDA) may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the IV and oral formulations of SCY-247.
About SCYNEXIS
About SCYNEXIS
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company's proprietary antifungal platform "fungerps". Ibrexafungerp, the first representative of this novel class, has been licensed to GSK. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phase, including the compound SCY-247. For more information, visit .
SCYNEXIS, Inc. (NASDAQ: SCYX) is a biotechnology company pioneering innovative medicines to help millions of patients worldwide overcome and prevent difficult-to-treat infections that are becoming increasingly drug-resistant. SCYNEXIS is developing the company's proprietary antifungal platform "fungerps". Ibrexafungerp, the first representative of this novel class, has been licensed to GSk. The U.S. Food and Drug Administration (FDA) approved BREXAFEMME (ibrexafungerp tablets) in June 2021, for its first indication in vulvovaginal candidiasis (VVC), followed by a second indication in November 2022, for reduction in the incidence of recurrent VVC. Late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing. Additional antifungal assets from this novel class are currently in pre-clinical and discovery phase, including the compound SCY-247. For more information, visit .
Forward-Looking Statements
前瞻性声明
Statements contained in this press release regarding expected future events or results are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including but not limited to statements regarding: SCYNEXIS anticipates that the U.S. Food and Drug Administration (FDA) may grant SCY-247 Qualified Infectious Disease Product (QIDP) and Fast Track designations for both the IV and oral formulations of SCY-247. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks inherent in regulatory and other costs in developing products. These and other risks are described more fully in SCYNEXIS' filings with the Securities and Exchange Commission, including without limitation, its most recent Annual Report on Form 10-K filed on March 28, 2024, and form 10-Q for the quarter ending September 30, 2024, including under the caption "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. SCYNEXIS undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
本新闻稿中有关预期未来事件或结果的陈述是1995年《私人证券诉讼改革法》所定义的“前瞻性陈述”,包括但不限于以下陈述:SCYNEXIS预计美国食品药品监督管理局(FDA)可能授予SCY-247合格传染病产品(QIDP)和加速审批资格,适用于SCY-247的静脉注射和口服配方。由于这些陈述受风险和不确定性的影响,实际结果可能与这些前瞻性陈述所表达或暗示的结果有显著不同。这些风险和不确定性包括但不限于在开发产品过程中固有的监管和其他成本风险。这些风险和其他风险在SCYNEXIS向证券交易委员会的文件中有更详细的描述,包括但不限于,其于2024年3月28日提交的最新年度报告(Form 10-k)和截至2024年9月30日的季度报告(Form 10-Q),其中包括“风险因素”栏目。本文中包含的所有前瞻性陈述仅在其发布之日有效。SCYNEXIS没有义务更新这些陈述以反映其发布后发生的事件或存在的情况。
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