SCYNEXIS Announces Positive Results from a Phase 1, Single Ascending Dose and Multiple Ascending Dose Study of its Second-Generation Fungerp (SCY-247)
SCYNEXIS (NASDAQ: SCYX) reported positive Phase 1 trial results for SCY-247, its second-generation triterpenoid antifungal drug. The study evaluated single ascending doses (SAD) from 50mg to 900mg and multiple ascending doses (MAD) from 50mg to 300mg in healthy participants.
The trial demonstrated favorable safety and tolerability profiles, with no serious adverse events. Key findings include dose-proportional pharmacokinetics, rapid absorption (Tmax 3-7 hours), and achievement of target exposures at lower doses compared to their first-generation fungerp. The most common side effects were mild to moderate headache (16.7% SCY-247 vs 4.5% placebo) and diarrhea (9% in both groups).
SCYNEXIS (NASDAQ: SCYX) ha riportato risultati positivi dello studio di fase 1 per SCY-247, il suo farmaco antifungino triterpenoide di seconda generazione. Lo studio ha valutato dosi singole ascendenti (SAD) da 50 mg a 900 mg e dosi ascendenti multiple (MAD) da 50 mg a 300 mg in soggetti sani. L'trial ha dimostrato profili di sicurezza e tollerabilità favorevoli, senza eventi avversi gravi. I risultati chiave includono farmacocinetica dose-dipendente, assorbimento rapido (Tmax 3-7 ore) e raggiungimento di esposizioni obiettivo a dosi inferiori rispetto alla prima generazione fungerp. Gli effetti indesiderati più comuni sono mal di testa da lieve a moderato (16,7% di SCY-247 vs 4,5% del placebo) e diarrea (9% in entrambi i gruppi).
SCYNEXIS (NASDAQ: SCYX) informó resultados positivos de fase 1 para SCY-247, su fármaco antifúngico triterpenoide de segunda generación. El estudio evaluó dosis únicas ascendentes (SAD) de 50 mg a 900 mg y dosis ascendentes múltiples (MAD) de 50 mg a 300 mg en participantes sanos. El ensayo mostró perfiles de seguridad y tolerabilidad favorables, sin eventos adversos graves. Los hallazgos clave incluyen farmacocinética dosis-dependiente, absorción rápida (Tmax 3-7 horas) y logro de exposiciones objetivo a dosis más bajas en comparación con la primera generación fungerp. Los efectos secundarios más comunes fueron dolor de cabeza leve a moderado (16,7% SCY-247 frente a 4,5% placebo) y diarrea (9% en ambos grupos).
SCYNEXIS (NASDAQ: SCYX)은 2세대 트리테르페노이드 항진균제인 SCY-247에 대한 1상 임상 결과를 발표했습니다. 연구는 건강한 참가자들을 대상으로 50 mg에서 900 mg까지의 단일 증가 용량(SAD)과 50 mg에서 300 mg까지의 다중 증가 용량(MAD)을 평가했습니다. 이번 시험은 중대한 이상반응 없음을 포함한 안전성 및 내약성 프로필이 우수함을 보여주었습니다. 주요 발견은 용량-의존적 약동학, 빠른 흡수(Tmax 3-7시간), 1세대 fungerp에 비해 더 낮은 용량에서도 목표 노출 달성입니다. 가장 흔한 부작용은 두통이 경증에서 중등도(SCY-247: 16.7% vs 위약: 4.5%)이고, 설사(9%)도 양 그룹에서 나타났습니다.
SCYNEXIS (NASDAQ: SCYX) a annoncé des résultats positifs de phase 1 pour SCY-247, son médicament antifongique triténoïde de deuxième génération. L’étude a évalué des doses uniques croissantes (SAD) de 50 mg à 900 mg et des doses croissantes multiples (MAD) de 50 mg à 300 mg chez des participants sains. L’étude a démontré des profils de sécurité et de tolérance favorables, sans événements indésirables graves. Les résultats clés incluent une pharmacocinétique dose-dépendante, une absorption rapide (Tmax 3-7 heures) et l’atteinte d’expositions cibles à des doses inférieures par rapport à la première génération de fungerp. Les effets indésirables les plus fréquents étaient des maux de tête légers à modérés (16,7% SCY-247 vs 4,5% placebo) et des diarrhées (9% dans les deux groupes).
SCYNEXIS (NASDAQ: SCYX) hat positive Ergebnisse der Phase-1-Studie für SCY-247, sein antifungales Triterpenoid-Antimykotikum der zweiten Generation, gemeldet. Die Studie bewertete einzelne aufsteigende Dosen (SAD) von 50 mg bis 900 mg und Multiple aufsteigende Dosen (MAD) von 50 mg bis 300 mg bei gesunden Probanden. Die Studie zeigte ein günstiges Sicherheits- und Verträglichkeitsprofil, ohne schwere unerwünschte Ereignisse. Zu den Schlüsselergebnissen gehören dosisproportionale Pharmakokinetik, schnelle Absorption (Tmax 3-7 Stunden) und das Erreichen von Ziel-Expositionen bei niedrigeren Dosen im Vergleich zur ersten Generation fungerp. Die häufigsten Nebenwirkungen waren Kopfschmerzen von leicht bis moderat (16,7% SCY-247 vs 4,5% Placebo) und Durchfall (9% in beiden Gruppen).
أعلنت SCYNEXIS (المدرجة في ناسداك: SCYX) عن نتائج إيجابية في المرحلة الأولى لـ SCY-247، دوائها المضاد للفطريات من الجيل الثاني القائم على التربترينويد. درست الدراسة جرعات مفردة تزايديـة (SAD) من 50 ملغ إلى 900 ملغ وجرعات تزايديـة متعددة (MAD) من 50 ملغ إلى 300 ملغ في مشاركين أصحاء. أظهر التجربة ملفات أمان وتحمل جيدة، دون أحداث جانبية خطيرة. تشمل النتائج الرئيسية وجود دواء يعتمد على الجرعة-Dynamics، والامتصاص السريع (Tmax 3-7 ساعات)، وتحقيق تعرّضات هدف عند جرعات أدنى مقارنة بالجيل الأول من fungerp. وأكثر الآثار الجانبية شيوعاً هي صداع خفيف إلى متوسط (16.7% لـ SCY-247 مقابل 4.5%_placebo) والإسهال (9% في كلا المجموعتين).
SCYNEXIS（纳斯达克：SCYX）公布了二代三萜类抗真菌药物 SCY-247 的 1 期临床结果。研究在健康受试者中评估了从 50 mg 到 900 mg 的单次递增剂量（SAD）以及 50 mg 到 300 mg 的多次递增剂量（MAD）。试验显示安全性与耐受性良好，未出现 严重不良事件。关键发现包括剂量依赖性药代动力学、快速吸收（Tmax 3-7 小时），在较低剂量下达到目标暴露，相比第一代 fungerp。最常见的副作用为轻度至中度头痛（16.7% 的 SCY-247 对比 4.5% 的安慰剂）和腹泻（9%，两组皆有）。
- None.
- One participant discontinued the study due to an adverse event (though deemed unrelated)
- Higher incidence of headache in treatment group (16.7%) compared to placebo (4.5%)
Insights
SCYNEXIS's second-gen antifungal SCY-247 shows favorable Phase 1 safety profile with lower effective doses than first-gen product.
The Phase 1 results for SCYNEXIS's SCY-247 represent a meaningful step forward in their antifungal pipeline. The study demonstrated no serious adverse events across single and multiple ascending dose cohorts, with only mild to moderate side effects reported at rates similar to placebo in some cases. Most importantly, the drug achieved target exposures for efficacy at doses lower than their first-generation fungerp, potentially conferring a significant tolerability advantage.
The pharmacokinetic data revealed dose-proportional behavior with rapid absorption (Tmax 3-7 hours), and the 200mg and 300mg daily doses reached or exceeded preliminary efficacy targets based on preclinical models. This is particularly notable for difficult-to-treat infections including Candida auris and echinocandin-resistant Candida glabrata - pathogens that represent serious clinical challenges with limited treatment options.
From a development perspective, these results effectively de-risk the program's early safety hurdles and provide a solid foundation for advancing SCY-247 to Phase 2 trials. The potential for both oral and IV formulations addresses a significant unmet need in antifungal therapy, where treatment flexibility is crucial. For invasive fungal infections, which carry high mortality rates, this dual-formulation approach could allow for IV initiation in severely ill patients with transition to oral therapy - a valuable clinical pathway currently limited with existing antifungals.
These positive Phase 1 results strengthen SCYNEXIS's antifungal portfolio and support their strategic positioning in addressing resistant fungal infections, a growing concern in infectious disease management.
- No safety concerns or dose limiting toxicities observed
- SCY-247 was able to achieve target exposures at doses lower than our first-generation fungerp
- Safety, tolerability, and pharmacokinetic profile support the continued clinical development of SCY-247
JERSEY CITY, N.J., Sept. 30, 2025 (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 positive results from a Phase 1 study of SCY-247, its second-generation triterpenoid antifungal under development for the treatment and prevention of invasive fungal infections with the potential to provide the therapeutic advantages of both an oral and IV formulation.
“We are pleased by the favorable results from this Phase 1 study demonstrating that orally administered SCY-247 can achieve target exposures for efficacy with favorable tolerability,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “We also observed that orally administered SCY-247 was able to achieve target exposures for invasive fungal disease at doses lower than our first generation fungerp, which may translate to a tolerability advantage. There remains a substantial unmet need for safe and effective, oral and intravenous antifungal agents to treat invasive fungal infections, particularly those caused by resistant fungi. The clinical data from our Phase 1 study, along with pre-clinical efficacy data generated to date, favorably position SCY-247 as a strong product candidate to meet these significant needs. We are looking forward to continuing the development of our second generation fungerp.”
Phase 1 Study Description:
The study evaluated the safety, tolerability and pharmacokinetics of orally administered SCY-247 in healthy participants receiving single ascending doses (SAD) ranging from 50mg to 900mg and multiple ascending doses (MAD) ranging from 50mg to 300mg, once a day for 7 days. Each dose level was evaluated in 8 participants, with 6 participants receiving SCY-247 and 2 receiving a matching placebo. A total of 66 participants received SCY-247 and 22 received placebo in the SAD and MAD cohorts.
Phase 1 Study Results:
SCY-247 was well tolerated across all evaluated SAD and MAD cohorts. No serious or severe treatment emergent adverse events (TEAEs) were reported. The incidence of TEAEs was low and not dose-dependent, with all events being mild or moderate in severity. One participant discontinued the study due to an adverse event that was deemed not to be related to the study drug. The most common adverse events were mild to moderate headache reported in
SCY-247 showed generally dose-proportional pharmacokinetics following single and multiple oral doses. The drug was rapidly absorbed (Tmax ranging from 3 to 7 hours), and systemic exposure (Cmax and AUC) increased with dose. The MAD cohorts of 200mg and 300mg once-daily achieved or exceeded the preliminary target for efficacious exposure, based on pre-clinical models of invasive candidiasis available to date, including models with strains such as Candida auris and echinocandin-resistant Candida glabrata that are resistant to current antifungal treatment options. Overall, the safety, tolerability, and pharmacokinetic profile observed in this study support the continued clinical development of SCY-247. Further details of the results from this study will be presented at an upcoming scientific meeting.
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 clinical, pre-clinical and discovery phases, 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: any advantages of SCY-247 over existing antifungals and continued development 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 12, 2025, 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: 917-734-7387
ikoffler@lifesciadvisors.com
FAQ
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