SCYNEXIS Initiates Dosing in Phase 1 Trial of SCY-247, a Second-Generation Fungerp Candidate for Invasive Fungal Infections
SCYNEXIS (NASDAQ: SCYX) has initiated dosing in a Phase 1 trial of SCY-247, its second-generation triterpenoid antifungal candidate designed to combat severe invasive fungal infections. The trial is a randomized, double-blind, placebo-controlled study involving approximately 100 healthy subjects, focusing on single and multiple ascending doses of oral SCY-247.
The study's primary endpoint is safety and tolerability, with pharmacokinetics as the secondary endpoint. SCY-247 has shown promising results in preclinical models and demonstrates activity against fungi listed on the WHO fungal priority pathogen list. The development addresses growing concerns about drug resistance and increasing mortality rates in vulnerable populations affected by invasive fungal diseases.
SCYNEXIS (NASDAQ: SCYX) ha avviato la somministrazione in una sperimentazione clinica di fase 1 di SCY-247, il suo candidato antifungino di seconda generazione progettato per combattere gravi infezioni fungine invasive. Lo studio è un trial randomizzato, in doppio cieco e controllato con placebo che coinvolge circa 100 soggetti sani, focalizzandosi su dosi ascendenti singole e multiple di SCY-247 somministrato per via orale.
L'endpoint principale dello studio è la sicurezza e la tollerabilità, con la farmacocinetica come endpoint secondario. SCY-247 ha mostrato risultati promettenti in modelli preclinici e dimostra attività contro i funghi presenti nell'elenco delle priorità dell'OMS per i patogeni fungini. Lo sviluppo affronta le crescenti preoccupazioni per la resistenza ai farmaci e l'aumento dei tassi di mortalità nelle popolazioni vulnerabili colpite da malattie fungine invasive.
SCYNEXIS (NASDAQ: SCYX) ha iniciado la dosificación en un ensayo de fase 1 de SCY-247, su candidato antifúngico de segunda generación diseñado para combatir infecciones fúngicas invasivas severas. El ensayo es un estudio aleatorizado, doble ciego y controlado con placebo que involucra aproximadamente 100 sujetos sanos, centrándose en dosis ascendentes únicas y múltiples de SCY-247 por vía oral.
El objetivo principal del estudio es la seguridad y tolerabilidad, con la farmacocinética como objetivo secundario. SCY-247 ha mostrado resultados prometedores en modelos preclínicos y demuestra actividad contra los hongos listados en la lista de patógenos fúngicos prioritarios de la OMS. El desarrollo aborda las crecientes preocupaciones sobre la resistencia a los medicamentos y el aumento de las tasas de mortalidad en poblaciones vulnerables afectadas por enfermedades fúngicas invasivas.
SCYNEXIS (NASDAQ: SCYX)는 심각한 침습성 곰팡이 감염에 맞서 싸우기 위해 설계된 2세대 트리테르페노이드 항진균 후보물질인 SCY-247의 1상 시험에서 투약을 시작했습니다. 이 시험은 약 100명의 건강한 피험자를 대상으로 하는 무작위 이중 맹검 위약 대조 연구로, 경구용 SCY-247의 단일 및 다중 증량 용량에 초점을 맞추고 있습니다.
연구의 주요 목표는 안전성과 내약성이며, 약리학적 동태가 2차 목표입니다. SCY-247은 전임상 모델에서 유망한 결과를 보였으며, WHO 곰팡이 우선 병원체 리스트에 나열된 곰팡이에 대해 활성을 나타냅니다. 이 개발은 드럭 저항성과 침습성 곰팡이 질환에 영향을 받은 취약 계층의 증가하는 사망률에 대한 우려를 다룹니다.
SCYNEXIS (NASDAQ: SCYX) a lancé la phase de dosage d'un essai de phase 1 pour SCY-247, son candidat antifongique de deuxième génération conçu pour combattre des infections fongiques invasives sévères. L'essai est une étude randomisée, en double aveugle et contrôlée par placebo, impliquant environ 100 sujets sains, axée sur des doses croissantes uniques et multiples de SCY-247 par voie orale.
Le critère principal de l'étude est la sécurité et la tolérabilité, avec la pharmacocinétique comme critère secondaire. SCY-247 a montré des résultats prometteurs dans des modèles précliniques et montre une activité contre les champignons figurant sur la liste des pathogènes fongiques prioritaires de l'OMS. Ce développement répond aux préoccupations croissantes concernant la résistance aux médicaments et les taux de mortalité croissants dans les populations vulnérables touchées par des maladies fongiques invasives.
SCYNEXIS (NASDAQ: SCYX) hat die Dosierung in einer Phase-1-Studie mit SCY-247, seinem Antimykotikum der zweiten Generation, das zur Bekämpfung schwerer invasiver Pilzinfektionen entwickelt wurde, aufgenommen. Die Studie ist eine randomisierte, doppelblinde, placebo-kontrollierte Untersuchung mit etwa 100 gesunden Probanden, die sich auf einzelne und multiple Steigerungsdosen von oral verabreichtem SCY-247 konzentriert.
Das primäre Ziel der Studie ist die Sicherheit und Verträglichkeit, während die Pharmakokinetik das sekundäre Ziel darstellt. SCY-247 hat in präklinischen Modellen vielversprechende Ergebnisse gezeigt und weist Aktivität gegen Pilze auf, die auf der Prioritätenliste der WHO für pilzliche Krankheitserreger aufgeführt sind. Die Entwicklung adressiert zunehmende Bedenken hinsichtlich der Arzneimittelresistenz und steigender Sterberaten bei anfälligen Bevölkerungsteilen, die von invasiven Pilzkrankheiten betroffen sind.
- Advancement to Phase 1 clinical trials with SCY-247
- Successful completion of first cohort dosing
- Demonstrated preclinical efficacy against WHO priority fungal pathogens
- Early-stage development (Phase 1) indicates long path to potential commercialization
- No efficacy data in humans yet available
Insights
The initiation of Phase 1 trials for SCY-247 marks a significant milestone in SCYNEXIS's antifungal development pipeline. This second-generation fungerp candidate shows particular promise due to its demonstrated preclinical activity against pathogens on the WHO fungal priority pathogen list. The trial's robust design involving 100 healthy subjects with both single and multiple ascending doses will provide important safety and pharmacokinetic data. However, investors should note that Phase 1 trials primarily focus on safety rather than efficacy and success here would only be an early step in the lengthy drug development process. The growing market for antifungal treatments, driven by increasing immunocompromised populations and rising drug resistance, presents a substantial opportunity, though commercialization remains years away pending successful completion of all clinical phases.
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.
“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.”
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.
About 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
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 www.scynexis.com.
Forward-Looking Statements
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.
CONTACT:
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com
FAQ
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