SCYNEXIS Resumes Patient Dosing in Phase 3 MARIO Study
SCYNEXIS (NASDAQ: SCYX) has resumed patient dosing in its Phase 3 MARIO study, investigating oral ibrexafungerp as a step-down therapy for invasive candidiasis following IV echinocandin treatment. The study's resumption follows the FDA's lifting of a clinical hold related to manufacturing site concerns. The trial has already enrolled approximately 25% of projected patients.
The dosing resumption triggers a disputed $10 million milestone payment from GSK, with an additional $20 million milestone due in six months. GSK contests these payments, and SCYNEXIS disagrees with their position. If successful, the study could provide healthcare providers with a non-azole oral therapy option that maintains the mechanism of action of IV-only echinocandins, considered the gold standard for treating invasive Candida infections.
SCYNEXIS (NASDAQ: SCYX) ha ripreso la somministrazione ai pazienti nel suo studio di Fase 3 MARIO, che indaga l'ibrexafungerp orale come terapia di step-down per la candidiasi invasiva dopo il trattamento con echinocandine endovenose. La ripresa dello studio segue la revoca da parte della FDA del blocco clinico legato a preoccupazioni sul sito di produzione. Il trial ha già arruolato circa il 25% dei pazienti previsti.
La ripresa della somministrazione attiva un controverso pagamento milestone da 10 milioni di dollari da parte di GSK, con un ulteriore pagamento milestone da 20 milioni previsto tra sei mesi. GSK contesta questi pagamenti, mentre SCYNEXIS non condivide la loro posizione. Se avrà successo, lo studio potrebbe offrire ai medici un'opzione terapeutica orale non azolica che mantiene il meccanismo d'azione delle echinocandine somministrate solo per via endovenosa, considerate lo standard d'oro per il trattamento delle infezioni invasive da Candida.
SCYNEXIS (NASDAQ: SCYX) ha reanudado la dosificación de pacientes en su estudio de Fase 3 MARIO, que investiga el ibrexafungerp oral como terapia de paso descendente para la candidiasis invasiva tras el tratamiento con equinocandinas intravenosas. La reanudación del estudio sigue a la eliminación por parte de la FDA de la suspensión clínica relacionada con preocupaciones sobre el sitio de fabricación. El ensayo ya ha inscrito aproximadamente al 25% de los pacientes proyectados.
La reanudación de la dosificación activa un controvertido pago por hito de 10 millones de dólares por parte de GSK, con un pago adicional de 20 millones de dólares previsto en seis meses. GSK disputa estos pagos y SCYNEXIS no está de acuerdo con su posición. Si tiene éxito, el estudio podría ofrecer a los proveedores de salud una opción terapéutica oral no azólica que mantiene el mecanismo de acción de las equinocandinas solo intravenosas, consideradas el estándar de oro para el tratamiento de infecciones invasivas por Candida.
SCYNEXIS (나스닥: SCYX)는 정맥내 에키노칸딘 치료 후 침습성 칸디다증에 대한 경구용 이브렉사펑거프를 단계적 전환 요법으로 조사하는 3상 MARIO 연구에서 환자 투약을 재개했습니다. 이 연구의 재개는 제조 시설 문제와 관련된 FDA의 임상 중단 해제에 따른 것입니다. 이 임상시험은 이미 예상 환자의 약 25%를 등록했습니다.
투약 재개는 GSK로부터의 논란이 있는 1,000만 달러 마일스톤 지급을 촉발하며, 6개월 후 추가로 2,000만 달러의 마일스톤 지급이 예정되어 있습니다. GSK는 이 지급에 이의를 제기하고 있으며, SCYNEXIS는 그 입장에 동의하지 않습니다. 성공할 경우, 이 연구는 침습성 칸디다 감염 치료의 금본위제로 간주되는 정맥주사 전용 에키노칸딘의 작용 기전을 유지하는 비-아졸 경구 치료 옵션을 의료 제공자에게 제공할 수 있습니다.
SCYNEXIS (NASDAQ : SCYX) a repris la distribution aux patients dans son étude de Phase 3 MARIO, qui évalue l'ibrexafungerp oral comme thérapie de transition pour la candidose invasive après un traitement par échinocandines intraveineuses. La reprise de l'étude fait suite à la levée par la FDA d'une suspension clinique liée à des préoccupations concernant le site de fabrication. L'essai a déjà recruté environ 25 % des patients prévus.
La reprise de la distribution déclenche un paiement jalon controversé de 10 millions de dollars de la part de GSK, avec un paiement supplémentaire de 20 millions de dollars prévu dans six mois. GSK conteste ces paiements, et SCYNEXIS n'est pas d'accord avec leur position. En cas de succès, l'étude pourrait offrir aux professionnels de santé une option thérapeutique orale non azolée qui maintient le mécanisme d'action des échinocandines administrées uniquement par voie intraveineuse, considérées comme la référence pour le traitement des infections invasives à Candida.
SCYNEXIS (NASDAQ: SCYX) hat die Patientendosierung in seiner Phase-3-MARIO-Studie wieder aufgenommen, in der orales Ibrexafungerp als Step-down-Therapie für invasive Candidiasis nach intravenöser Echinocandin-Behandlung untersucht wird. Die Wiederaufnahme der Studie folgt auf die Aufhebung eines klinischen Halts durch die FDA, der mit Bedenken bezüglich des Herstellungsstandorts zusammenhing. Die Studie hat bereits etwa 25% der geplanten Patienten eingeschlossen.
Die Wiederaufnahme der Dosierung löst eine umstrittene Meilensteinzahlung von 10 Millionen US-Dollar von GSK aus, mit einer weiteren Meilensteinzahlung von 20 Millionen US-Dollar in sechs Monaten. GSK bestreitet diese Zahlungen, und SCYNEXIS ist mit deren Position nicht einverstanden. Bei Erfolg könnte die Studie den Gesundheitsdienstleistern eine nicht-azole orale Therapieoption bieten, die den Wirkmechanismus der nur intravenös verabreichten Echinocandine beibehält, die als Goldstandard zur Behandlung invasiver Candida-Infektionen gelten.
- Resumption of Phase 3 MARIO study following FDA clinical hold lift
- Potential $30M in milestone payments ($10M immediate + $20M in 6 months)
- 25% of projected patient enrollment already achieved
- Strong support from scientific community and investigators
- Ongoing payment dispute with partner GSK over milestone payments
- Previous manufacturing site issues that led to clinical hold
- Uncertainty about receiving the disputed milestone payments
Insights
SCYNEXIS resumes Phase 3 trial after FDA hold lifted, but faces $30M milestone payment dispute with GSK.
SCYNEXIS has achieved a significant clinical milestone with the resumption of patient dosing in their Phase 3 MARIO study investigating oral ibrexafungerp as a step-down therapy for invasive candidiasis. This development comes after the FDA lifted a clinical hold related to manufacturing cross-contamination concerns, which SCYNEXIS resolved by producing new clinical supplies at an alternative manufacturing site.
The trial's resumption carries substantial financial implications, triggering a
From a clinical perspective, the MARIO study addresses a critical treatment gap in infectious disease management. Invasive candidiasis carries high mortality rates, and current treatment options are limited. The study's innovative approach investigating oral ibrexafungerp as step-down therapy from IV echinocandins could significantly improve treatment pathways by maintaining the same mechanism of action (glucan synthase inhibition) in an oral formulation. This would represent a meaningful therapeutic advancement for patients with these life-threatening fungal infections.
The rapid resumption of enrollment—with new patients being dosed just days after site reactivation—and the study having already reached approximately
- First new patient dosed in Phase 3 MARIO study following the lifting of the FDA clinical hold
- Resumption of dosing in this study triggers a
$10M milestone payment from GSK plus an additional$20M milestone due in six months; as previously disclosed GSK disputes these milestone payments, and SCYNEXIS vigorously disagrees with their position
JERSEY CITY, N.J., May 28, 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 that patient dosing has resumed in the Phase 3 MARIO study, which is an innovative study to investigate oral ibrexafungerp as a potential step-down antifungal therapy following IV echinocandin for invasive candidiasis, a life-threatening infection. The study had been on hold due to concerns about potential cross-contamination in light of draft U.S. Food and Drug Administration (FDA) guidance regarding manufacturing a non-antibiotic beta-lactam (ezetimibe) at the same site as ibrexafungerp. The study has resumed following the manufacture of new clinical supplies at another site and the lifting of the clinical hold by the FDA. If the study is successful and approval for this indication is granted by the FDA, it will give healthcare providers the opportunity to step-down their patients to a non-azole oral therapy that retains the Mechanism of Action (glucan synthase inhibition) of the IV-only echinocandins, which are the gold standard for treatment of invasive Candida infections. SCYNEXIS’s position is that the dosing of this first new patient triggers a
“We are pleased to announce the dosing of the first new patient in the Phase 3 MARIO study following the lifting of the clinical hold by the FDA in April,” said David Angulo, M.D., President and Chief Executive Officer. “The rapid resumption of patient enrollment, just a few days after the investigational sites were re-activated in the study, reflects the eagerness of the scientific community to have new treatment options for this life-threatening infection.”
SCYNEXIS is thankful to the investigators participating in this trial for their support and patience during the clinical hold period, and for their continued commitment to the successful completion of this important study, which has already enrolled approximately
“I’m happy to see this important study restarted, and glad that we have been able to contribute by enrolling a new patient,” said Barbara D. Alexander, MD, MHS, FIDSA Professor of Medicine and Pathology at Duke University and the Director of the Transplant Infectious Diseases Service. “We need additional treatment options for patients with invasive fungal diseases, and we are looking forward to the completion of this study evaluating oral ibrexafungerp in this area of significant unmet need.”
“There is substantial need for new treatments for invasive candidiasis, particularly for Candida strains resistant to the currently approved antifungals,” added Dr. Luis Ostrosky-Zeichner, MD, Professor of Medicine and Epidemiology and Chief at the Division of Infectious Diseases of the McGovern Medical School (UTHealth Houston). “Ibrexafungerp could play an important role in improving the outcome of patients with these life-threating infections, and I am glad to see this important study reinitiated in our institution.”
About Triterpenoid Antifungals
Triterpenoid antifungals (also known as “fungerps”) are a novel class of structurally distinct glucan synthase inhibitors that combine the well-established activity of glucan synthase inhibitors with the potential flexibility of having oral and intravenous (IV) formulations. They have demonstrated broad-spectrum antifungal activity against multidrug-resistant pathogens, including azole- and echinocandin-resistant strains. Ibrexafungerp is the first representative of this novel class of antifungal agents. Ibrexafungerp, formerly known as SCY-078, is currently approved in the U.S. for the treatment of vulvovaginal candidiasis and is in late-stage development for invasive candidiasis. The next generation fungerp, SCY-247, is currently in the late stages of a Phase 1 clinical study.
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.
CONTACT:
Investor Relations
Irina Koffler
LifeSci Advisors
Tel: (646) 970-4681
ikoffler@lifesciadvisors.com
FAQ
What caused the FDA clinical hold on SCYX's MARIO study?
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