SCYNEXIS Announces Multiple Presentations Highlighting Data from its Second-Generation Fungerp, SCY-247, at the 12th Congress on Trends in Medical Mycology (TIMM-12)
SCYNEXIS (NASDAQ: SCYX) announced multiple presentations highlighting data for its second-generation fungerp drug candidate SCY-247 at the upcoming TIMM-12 Congress in Bilbao, Spain (September 19-22, 2025). The data demonstrates SCY-247's potent activity against difficult-to-treat fungal infections, particularly Candida auris, including strains resistant to current treatments.
The six presentations showcase SCY-247's broad-spectrum antifungal activity against various Candida species and Aspergillus species, including multidrug- and pandrug-resistant strains. Key findings include lower MICs for C. auris compared to echinocandins, effectiveness against 300 C. auris isolates from the New York area, and significant activity in mouse models of invasive candidiasis.
The company expects to report Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) trial results for oral SCY-247 in Q3 2025.
SCYNEXIS (NASDAQ: SCYX) ha annunciato più presentazioni che metteranno in luce i dati sul suo candidato fungicida di seconda generazione, SCY-247, al prossimo congresso TIMM-12 a Bilbao, Spagna (19-22 settembre 2025). I risultati mostrano l'attività potente di SCY-247 contro infezioni fungine difficili da trattare, in particolare Candida auris, incluse ceppi resistenti alle terapie attuali.
Le sei presentazioni evidenziano l'attività antifungina ad ampio spettro di SCY-247 contro diverse specie di Candida e Aspergillus, compresi ceppi multiresistenti e pandrug-resistant. Risultati chiave includono MIC inferiori per C. auris rispetto agli echinocandini, efficacia su 300 isolati di C. auris provenienti dall'area di New York e attività significativa in modelli murini di candidiasi invasiva.
La società prevede di rendere noti i risultati della Fase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) per SCY-247 orale nel terzo trimestre 2025.
SCYNEXIS (NASDAQ: SCYX) anunció varias presentaciones que mostrarán datos sobre su candidato antifúngico de segunda generación, SCY-247, en el próximo congreso TIMM-12 en Bilbao, España (19-22 de septiembre de 2025). Los datos demuestran la potente actividad de SCY-247 frente a infecciones fúngicas difíciles de tratar, en particular Candida auris, incluidos aislamientos resistentes a los tratamientos actuales.
Las seis presentaciones ponen de relieve la actividad antifúngica de amplio espectro de SCY-247 frente a varias especies de Candida y Aspergillus, incluyendo cepas multirresistentes y pandrug-resistant. Hallazgos clave incluyen MIC más bajas para C. auris en comparación con los equinocandinas, eficacia contra 300 aislados de C. auris del área de Nueva York y actividad significativa en modelos murinos de candidiasis invasiva.
La compañía espera informar los resultados de la Fase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) para SCY-247 oral en el tercer trimestre de 2025.
SCYNEXIS (NASDAQ: SCYX)는 2025년 9월 19일~22일 스페인 빌바오에서 열리는 TIMM-12 학회에서 2세대 항진균제 후보물질 SCY-247 관련 데이터를 발표하는 여러 연제를 공개했습니다. 해당 데이터는 특히 기존 치료제에 내성을 보이는 균주를 포함한 Candida auris 등 난치성 진균 감염에 대한 SCY-247의 강력한 활성을 보여줍니다.
총 여섯 건의 발표에서는 여러 Candida 종과 Aspergillus 종에 대한 SCY-247의 광범위한 항진균 활성을 다루며, 다제내성 및 판드럭 저항성 균주에 대해서도 효과를 보였습니다. 주요 결과로는 에키노칸딘 계열에 비해 C. auris의 MIC가 낮음, 뉴욕 지역에서 수집된 300개 C. auris 분리주에 대한 효과, 침습성 칸디다증 마우스 모델에서의 유의미한 활성이 포함됩니다.
회사는 경구용 SCY-247에 대한 제1상 단회 상승용량/다회 상승용량(SAD/MAD) 시험 결과를 2025년 3분기에 보고할 예정입니다.
SCYNEXIS (NASDAQ: SCYX) a annoncé plusieurs communications mettant en avant des données sur son candidat antifongique de deuxième génération, SCY-247, lors du prochain congrès TIMM‑12 à Bilbao, Espagne (19-22 septembre 2025). Les données montrent la forte activité de SCY-247 contre des infections fongiques difficiles à traiter, en particulier Candida auris, y compris des souches résistantes aux traitements actuels.
Les six présentations soulignent l'activité antifongique à large spectre de SCY-247 contre différentes espèces de Candida et d'Aspergillus, y compris des souches multirésistantes et pandrug‑resistant. Les résultats clés incluent des CMI plus faibles pour C. auris par rapport aux échinocandines, l'efficacité contre 300 isolats de C. auris provenant de la région de New York et une activité significative dans des modèles murins de candidose invasive.
La société prévoit de communiquer les résultats de la Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) pour SCY-247 oral au troisième trimestre 2025.
SCYNEXIS (NASDAQ: SCYX) gab mehrere Präsentationen bekannt, die Daten zu seinem Antipilz-Kandidaten der zweiten Generation SCY-247 auf dem bevorstehenden TIMM-12-Kongress in Bilbao, Spanien (19.–22. September 2025), vorstellen werden. Die Daten zeigen die starke Wirksamkeit von SCY-247 gegen schwer zu behandelnde Pilzinfektionen, insbesondere Candida auris, einschließlich gegen aktuelle Therapien resistente Stämme.
Die sechs Präsentationen demonstrieren die breitbandige antifungale Aktivität von SCY-247 gegen verschiedene Candida- und Aspergillus-Arten, darunter multiresistente und pandrug-resistente Stämme. Wichtige Befunde sind niedrigere MIC-Werte für C. auris im Vergleich zu Echinokandinen, Wirksamkeit gegen 300 C. auris-Isolate aus dem Raum New York und signifikante Aktivität in Mausmodellen der invasiven Candidiasis.
Das Unternehmen rechnet damit, die Ergebnisse der Phase‑1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD)-Studie für orale SCY-247 im 3. Quartal 2025 zu berichten.
- Strong in vitro activity demonstrated against resistant C. auris strains, including FKS1 mutants
- Effective against 300 C. auris isolates, including pandrug-resistant strains
- Showed significant efficacy in mouse models of invasive candidiasis
- No cross-resistance observed with echinocandins across 293 Candida isolates
- Phase 1 SAD/MAD trial results expected in Q3 2025
- Moderately high MECs observed against L.prolificans strains
Insights
SCYNEXIS's SCY-247 shows promising activity against resistant fungal pathogens, with Phase 1 data expected soon.
SCYNEXIS is showcasing extensive preclinical data for SCY-247, their second-generation triterpenoid antifungal, at the upcoming TIMM-12 Congress. The presentations highlight a critical unmet medical need in infectious disease - the emergence of multidrug-resistant and even pandrug-resistant fungal pathogens, particularly Candida auris.
The data demonstrates several significant advantages of SCY-247. Most notably, SCY-247 maintains activity against C. auris strains with FKS1 mutations that typically confer echinocandin resistance. This is particularly important as echinocandins are often the last line of defense against resistant Candida infections. The compound also shows consistent activity across diverse Candida species without cross-resistance to echinocandins.
The preclinical package is comprehensive, featuring both in vitro activity against clinical isolates and in vivo efficacy in mouse models of invasive candidiasis. For C. glabrata, another concerning pathogen designated as high priority by WHO, SCY-247 maintained activity against echinocandin-resistant strains.
Beyond Candida, SCY-247 also demonstrated activity against Aspergillus species and moderate activity against Lomentospora prolificans, suggesting potential broad-spectrum applications. The upcoming Phase 1 SAD/MAD results in Q3 2025 will be crucial to determine if this promising preclinical profile translates to humans with an acceptable safety profile. The availability of both IV and oral formulations would be particularly valuable for transitioning patients from hospital to outpatient settings if development continues successfully.
SCY-247 shows strong antifungal activity against resistant pathogens, positioning SCYNEXIS well ahead of Phase 1 data release.
SCYNEXIS is strategically advancing its clinical pipeline with SCY-247, a novel triterpenoid antifungal with significant market potential. The compound addresses the urgent threat of antimicrobial resistance, specifically targeting Candida auris - a pathogen that has seen a 200% increase in U.S. incidence from 2019 to 2023 according to the presented data.
What stands out from these presentations is SCY-247's differentiated mechanism that appears to overcome resistance to echinocandins, the current standard of care for many invasive fungal infections. The compound demonstrated activity against C. auris isolates across all five major clades, including those with FKS1 mutations that typically confer echinocandin resistance. This suggests a potential breakthrough for patients with limited treatment options.
From a product development perspective, SCY-247's dual formulation strategy (both IV and oral) is particularly valuable. This flexibility could potentially support use across the full treatment spectrum - from acute hospital care to outpatient maintenance therapy. The oral efficacy data showing similar results between once-daily and twice-daily dosing is particularly promising for patient compliance if the compound advances.
The upcoming Phase 1 SAD/MAD results will be a critical inflection point to validate whether SCY-247's promising preclinical profile translates to humans with acceptable pharmacokinetics and safety. With mounting resistance to existing antifungals and few novel mechanisms in late-stage development, a successful clinical program could position SCYNEXIS to address a significant and growing medical need in the infectious disease space.
- Oral presentation will feature data demonstrating SCY-247 in vitro activity against C. auris strains, including isolates with mutations commonly associated with echinocandin-resistance
- Additional poster presentations highlight SCY-247’s broad spectrum of antifungal activity, against Candida species, including multidrug- and pandrug-resistant C. auris and Aspergillus species
- Company anticipates reporting Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) data for SCY-247 (oral) in Q3 2025
JERSEY CITY, N.J., Sept. 04, 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 multiple upcoming presentations highlighting data on the Company’s second-generation fungerp drug candidate, SCY-247, at the upcoming 12th Congress on Trends in Medical Mycology (TIMM-12), which is scheduled to take place from September 19th to 22nd, 2025, in Bilbao, Spain.
“Our six presentations at this year’s TIMM-12 Congress highlight the significant potential of SCY-247 to combat difficult, resistant Candida infections, including C. auris,” said David Angulo, M.D., President and Chief Executive Officer of SCYNEXIS. “We are developing SCY-247 to specifically address one of the most serious and challenging issues in infectious disease, and the data from these presentations provide highly encouraging evidence that SCY-247 has the potential to address these difficult-to-treat and life-threatening fungal infections. Later this quarter, we anticipate reporting results from our Phase 1 SAD/MAD trial of SCY-247, which represents an important next step in further advancing this exciting program.”
SCY-247 data presentations at TIMM-12:
Title | SCY-247, a Novel Second-Generation IV/Oral Triterpenoid Antifungal, Demonstrates In vitro Activity against C. auris, including the majority of FKS1 mutants |
Session: | Oral Presentation, S15.5S |
Session Date: | Saturday, September 20, 2025 |
Presentation Start Time | 17:25 Central European Time (CET) (10 minutes) |
Presenting Author | Eelco Meijer, MD, PhD Affiliations: Canisius-wilhelmina Hospital (CWZ)/Dicoon, Radboudumc-CWZ Center of Expertise for Mycology |
Summary: | Candida auris is a public health concern causing large and persistent outbreaks in healthcare institutions, globally. High incidence of resistance to approved antifungals necessitates investigation of novel drugs for future patient care. Here, we performed antifungal susceptibility testing on the investigational compound SCY-247 and other antifungals, including echinocandins anidulafungin and micafungin against 65 unique FKS1 resistant C. auris isolates representing clades I, II, III, IV, and V. Overall, in comparison to the echinocandins, SCY-247 consistently demonstrated lower MICs for C. auris in isolates with commonly found FKS1 resistance mutations. |
Title | Three Months of SCY-247 EUCAST MIC Testing: Uniform Activity Against Candida Species and No Cross-Resistance to Echinocandins |
Poster # | P052 |
Session Date | Sunday, 21 September 2025 |
Presentation Start Time | 11:15 CET (30 minutes) |
Presenting Author | Karin Meinike Jørgensen PhD Affiliations: Statens Serum Institut |
Summary | We present the first three months of EUCAST SCY-247 MICs compared to anidulafungin and micafungin MICs of 293 Candida isolates. SCY-247 displayed uniform activity against all Candida species included, with no indication of cross-resistance to the echinocandins. |
Title | In vitro efficacy of second-generation triterpenoid antifungal, SCY-247 against multidrug- and pandrug-resistant Candida auris |
Poster # | P053 |
Session Date | Saturday, 20 September 2025 |
Presentation Start Time | 11:15 CET (30 minutes) |
Presenting Author | Vishnu Chaturvedi, PhD Affiliations: New York Medical College, Valhalla, New York |
Summary: | Candida auris is a newly recognized global health threat by the CDC and WHO. In the USA, the New York –New Jersey metropolitan area remains a hotbed for multidrug- and pandrug-resistant C. auris strains. 300 C. auris isolates, mostly from New York area, were tested against SCY-247 and 10 other antifungal agents. SCY-247 demonstrated potent activity against C. auris including pandrug-resistant isolates. |
Title | The Novel Second-Generation IV/Oral Triterpenoid SCY-247 Maintains In vitro and In vivo Activity against Resistant Candida glabrata |
Poster # | P423 |
Session Date | Saturday, 20 September 2025 |
Presentation Start Time | 11:15 CET (30 minutes) |
Presenting Author | Nathan Wiederhold, PhD Affiliations: University of Texas Health Science Center at San Antonio |
Summary | Candida glabrata is a major cause of invasive candidiasis and is considered a high priority pathogen by the WHO. In vitro susceptibility testing was performed against 29 echinocandin-resistant clinical strains of C. glabrata. SCY-247 maintained in vitro activity against echinocandin-resistant C. glabrata and also demonstrated in vivo efficacy in an invasive candidiasis mice model caused by an echinocandin- and fluconazole-resistant C. glabrata strain. |
Title | Efficacy of once or twice daily oral SCY-247, a second-generation triterpenoid antifungal, in a murine model of Candida auris infection |
Poster # | P426 |
Theme | New antifungal agents |
Session Date | Sunday, 21 September 2025 |
Presentation Start Time | 11:15 CET (30 minutes) |
Presenting Author | Mahmoud Ghannoum, PhD Affiliations: Case Western Reserve University and University Hospitals Cleveland Medical Center |
Summary | Candida auris is a multidrug resistant fungus exhibiting a |
Title | In vitro activity of SCY-247 and comparators against clinical isolates of Aspergillus spp. and Lomentospora prolificans |
Poster # | P427 |
Theme | New Antifungal Agents |
Session Date | Saturday, 20 September 2025 |
Presentation Start Time | 11:15 CET (30 minutes) |
Presenting Author | Anastasiia Hrynzovska Affiliations: Mycology Reference Laboratory, National Centre for Mycology, Bogomolets National Medical University |
Summary | The aim of this study is to investigate the in vitro activity of SCY-247 against cryptic Aspergillus species and Lomentospora prolificans isolated from clinical samples. A total of 54 clinical isolates were analyzed including cryptic species of Aspergillus (n=48) and Lomentospora prolificans (n=6). SCY-247 activity was compared to 3 marketed antifungals. SCY-247 exhibited low MECs against cryptic Aspergillus species and moderately high MECs against L.prolificans. |
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: Company anticipates reporting Phase 1 Single Ascending Dose/Multiple Ascending Dose (SAD/MAD) data for SCY-247 (oral) in Q3, 2025. 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:
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Irina Koffler
LifeSci Advisors
Tel: 917-734-7387
ikoffler@lifesciadvisors.com
