[Translation] A phase III, multicenter, prospective, randomized, double-blind study comparing two treatment regimens (IV echinocandin followed by oral ibrexafungerp vs. IV echinocandin followed by oral fluconazole) in patients with candidemia and/or invasive candidiasis (MARIO)

主要研究目的：在念珠菌血症和/或侵袭性念珠菌病患者中，评估IV 棘白菌素后口服Ibrexafungerp 第30 天的全因死亡率（All Cause Moritality, ACM）非劣效于IV 棘白菌素后口服氟康唑的治疗方案；关键次要研究目的：在念珠菌血症和/或侵袭性念珠菌病患者中，评估IV 棘白菌素后口服Ibrexafungerp 第14 天的总体应答率（经数据审查委员会 [Data Review Committee, DRC] 判定的临床、影像学和真菌学方面的综合应答）非劣效于IV 棘白菌素后口服氟康唑的治疗方案；其他次要目的：根据第30天和抗真菌治疗结束时的总体应答、临床应答、真菌学应答、无复发、患者存活且真菌学清除指标来评估有效性；评估IV棘白菌素后口服Ibrexafungerp治疗的安全性；评估Ibrexafungerp的药代动力学（PK）特征。

[Translation]

The primary study objective was to evaluate the non-inferiority of oral ibrexafungerp after IV echinocandin to oral fluconazole in terms of all-cause mortality (ACM) at day 30 in patients with candidemia and/or invasive candidiasis. The key secondary study objective was to evaluate the non-inferiority of oral ibrexafungerp after IV echinocandin to oral fluconazole at day 14 in patients with candidemia and/or invasive candidiasis (composite clinical, radiological, and mycological responses as assessed by the Data Review Committee [DRC]). Other secondary objectives were to evaluate the efficacy based on overall response, clinical response, mycological response, freedom from relapse, patient survival, and fungal clearance at day 30 and at the end of antifungal treatment; to evaluate the safety of oral ibrexafungerp after IV echinocandin; and to evaluate the pharmacokinetic (PK) characteristics of ibrexafungerp.

Start Date18 Mar 2023

Sponsor / Collaborator

SCYNEXIS, Inc.

[+1]

ISRCTN51111674 / RecruitingPhase 1

A phase I, open-label, single-centre study to evaluate the absorption, distribution, metabolism and excretion (ADME) of oral [14C]-ibrexafungerp in healthy male subjects after repeat dosing

Start Date15 Dec 2022

Sponsor / Collaborator-

NCT05668429 / CompletedPhase 1

A Phase 1, Open-Label, Single-Centre Study to Evaluate the Absorption, Distribution, Metabolism and Excretion (ADME) of Oral [14^C]-Ibrexafungerp in Healthy Male Subjects After Repeat Dosing

This is a Phase 1, open-label, single center, non-randomized study to evaluate the absorption, distribution, metabolism and excretion (ADME) of an oral solution of radiolabeled Ibrexafungerp following repeat administration in healthy male subjects. All subjects will undergo preliminary screening procedures, will remain the clinical unit for approximately 26 days and will receive radiolabeled Ibrexafungerp, orally for 3 days.

Start Date14 Dec 2022

Sponsor / Collaborator

SCYNEXIS, Inc.

100 Clinical Results associated with Ibrexafungerp Citrate

100 Translational Medicine associated with Ibrexafungerp Citrate

100 Patents (Medical) associated with Ibrexafungerp Citrate

135

Literatures (Medical) associated with Ibrexafungerp Citrate

01 Oct 2024·MYCOPATHOLOGIA

Usage of Antifungal Agents in Pediatric Patients Versus Adults: Knowledge and Gaps

Review

Author: Roilides, Emmanuel ; Kourti, Maria

Invasive fungal infections (IFIs) present significant challenges in managing hospitalized and immunocompromised pediatric patients, contributing to high morbidity and mortality. Despite advancements in diagnostics and treatment, outcomes remain suboptimal due to unique clinical epidemiology, lack of pediatric-specific trials, and varied pharmacokinetics. The emergence of new antifungal classes and agents has expanded our options for preventing and treating IFIs in children, enhancing the safety and effectiveness of antifungal therapy. The oral formulations of ibrexafungerp, fosmanogepix and olorofim along with the extended dosing intervals of rezafungin show promising features for effective antifungal treatment in pediatrics. Despite the promising potential of novel antifungal drugs, their performance in heavily immunosuppressed patients remains unstudied. Until then, dedicated antifungal stewardship programs for high-risk patients are essential to optimize therapeutic outcomes, improve patient care, and limit the emergence of resistance.

01 Oct 2024·Infection

Efficacy and safety of oral ibrexafungerp in Chinese patients with vulvovaginal candidiasis: a phase III, randomized, double-blind study

Article

Author: Li, Yingxiong ; Xue, Fengxia ; Patiman, Mijiti ; An, Ruifang ; Lin, Jiajing ; Zhang, Songling ; Hu, Lina ; Chen, Lihong ; Jia, Wen ; Shi, Hong ; Wang, Wenying ; Wang, Shijin ; Xu, Dabao ; Wu, Qiong ; Qian, Sumin ; Zhang, Bei ; Wang, Xu ; Wang, Gang ; Liao, Qinping ; Wang, Xiaoli ; Li, Chuan ; Li, Jingjing ; Lu, Jing ; Ye, Hong ; Ruan, Qi ; Qiu, Jin ; Luo, Xiaowan ; Shi, Ling ; Ruan, Hongjie ; Zhang, Chunlian ; Wang, Xiaoqian ; Xu, Hongyan ; Song, Weihua ; Wang, Baojin ; Zhang, Chun

Abstract:

Purpose:

To evaluate the efficacy and safety of oral ibrexafungerp (HS-10366) versus placebo in Chinese patients with vulvovaginal candidiasis (VVC).

Methods:

A double-blind, placebo-controlled, randomized, multicenter phase III study was conducted in symptomatic VVC patients. Patients received (2:1) twice-daily oral ibrexafungerp 300 mg or matching placebo for 1 day. The primary endpoint was clinical cure (vulvovaginal signs and symptoms [VSS] score = 0) at test-of-cure (TOC) on day 11 ± 3. The secondary endpoints included mycological eradication, overall response, and clinical improvement (VSS score ≤ 1) at TOC, and vulvovaginal symptom resolution at follow-up on day 25 ± 4.

Results:

In total, 360 patients were included in the modified intention-to-treat set (defined as positive Candida cultured and receiving at least one study drug; 239 for ibrexafungerp, 121 for placebo). Compared with placebo, patients receiving ibrexafungerp had a significantly higher proportion of clinical cure (51.0% vs. 25.6%), mycological eradication (55.6% vs. 18.2%), overall response (33.9%, vs. 8.3%) at TOC and complete symptom resolution (74.5% vs. 39.7%, all P < 0.001) at follow-up. Subgroup analysis of clinical cure indicated that patients with C. albicans could benefit from ibrexafungerp over placebo. A similar benefit trend was also observed in those with non-albicans Candida by post-hoc analysis. Further analyses revealed similar efficacy of ibrexafungerp between patients with fluconazole non-susceptible C. albicans and fluconazole susceptible C. albicans regarding clinical cure and mycological eradication. Ibrexafungerp was generally well tolerated. Adverse events were primarily gastrointestinal and were mainly mild in severity.

Conclusions:

As a first-in-class antifungal agent, ibrexafungerp demonstrated promising efficacy and favorable safety for VVC treatment in Chinese patients.

Chinadrugtrials.org.cn registry number:

CTR20220918.

06 Aug 2024·Microbiology Spectrum

Brilacidin, a host defense peptide mimetic, potentiates ibrexafungerp antifungal activity against the human pathogenic fungus Aspergillus fumigatus

Article

Author: de Castro, Patrícia Alves ; Diehl, Camila ; Pinzan, Camila Figueiredo ; Dos Reis, Thaila Fernanda ; Goldman, Gustavo H

ABSTRACT:

Aspergillus fumigatus is the primary etiological agent of aspergillosis. Here, we show that the host defense peptide mimetic brilacidin (BRI) can potentiate ibrexafungerp (IBX) against clinical isolates of A. fumigatus . BRI + IBX can inhibit the growth of A. fumigatus voriconazole- and caspofungin-resistant clinical isolates. BRI is a small molecule host defense peptide mimetic that has previously exhibited broad-spectrum immunomodulatory/anti-inflammatory activity against viruses, bacteria, and fungi. In vitro , combination of BRI + IBX plays a fungicidal role, increases the fungal cell permeability, decreases the fungal survival in the presence of A549 epithelial cells, and appears as a promising antifungal therapeutic alternative against A. fumigatus .

IMPORTANCE:

Invasive fungal infections have a high mortality rate causing more deaths annually than tuberculosis or malaria. Aspergillus fumigatus causes a series of distinct invasive fungal infections have a high mortality rate causing more deaths annually than tuberculosis or malaria. A. fumigatus causes a spectrum of distinct clinical entities named aspergillosis, which the most severe form is the invasive pulmonary aspergillosis. There are few therapeutic options for treating aspergillosis and searching for new antifungal agents against this disease is very important. Here, we present brilacidin (BRI) as a synergizer o fibrexafungerp (IBX) against A. fumigatus . BRI is a small molecule host defense peptide mimetic that has previously exhibited broad-spectrum immunomodulatory/anti-inflammatory activity against bacteria and viruses. We propose the combination of BRI and IBX as a new antifungal combinatorial treatment against aspergillosis.

News (Medical) associated with Ibrexafungerp Citrate

16 Oct 2024

·www.gsk.com

Gepotidacin accepted for priority review by US FDA for treatment of uncomplicated urinary tract infections in female adults and adolescents

16 October 2024 Application supported by positive results from pivotal phase III EAGLE-2 and EAGLE-3 trials 26 March 2025 assigned as action date for FDA decision Gepotidacin could be the first in a new class of oral antibiotic treatment for uUTIs in over 20 years GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for the treatment of female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs). The FDA has granted Priority Review for this application and assigned a Prescription Drug User Fee Act (PDUFA) action date of 26 March 2025. Over half of all women are affected by uUTIs in their lifetime1, with approximately 30% suffering from recurrent disease which can cause significant patient burden, including discomfort and restriction of daily activities.2 New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing and can result in higher treatment failure rates.3 Gepotidacin is a late-stage antibiotic in GSK’s growing infectious disease portfolio and could be the first in a new class of oral antibiotics for uUTIs in over 20 years. The NDA is supported by positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials. In these studies, gepotidacin demonstrated non-inferiority to nitrofurantoin, the current standard of care for uUTI, in female adults (≥40 kg) and adolescents (≥12 years, ≥40 kg) with a confirmed uUTI and a uropathogen susceptible to nitrofurantoin. In EAGLE-3, gepotidacin achieved statistically significant superiority versus nitrofurantoin, demonstrating therapeutic success in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin (treatment difference 14.6%, 95% CI (6.4, 22.8)). In EAGLE-2, gepotidacin demonstrated therapeutic success in 50.6% (162/320) of participants compared to 47.0% (135/287) for nitrofurantoin (treatment difference 4.3%, 95% CI (-3.6, 12.1)). The safety and tolerability profile of gepotidacin in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials of gepotidacin. The most commonly reported adverse events (AEs) in gepotidacin participants were gastrointestinal (GI). Diarrhoea was the most common (16% of participants), followed by nausea (9%). Of the participants who reported GI AEs in the gepotidacin group, the maximum severity were mild (69% Grade 1) and moderate (28% Grade 2). Participants with Grade 3 GI events accounted for 3% of all patients with GI events and occurred in <1% of all participants. There was one drug-related serious adverse event in each treatment arm (gepotidacin and nitrofurantoin) across the two trials. The development of gepotidacin has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C and with federal funds awarded by the Defense Threat Reduction Agency under agreement number HDTRA1-07-9-0002. About the EAGLE (Efficacy of Antibacterial Gepotidacin Evaluated) phase III programme The global phase III clinical programme for gepotidacin in adults and adolescents consists of three trials: EAGLE-2 and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and safety of gepotidacin (1,500mg administered orally twice daily for five days) to nitrofurantoin (100mg administered orally twice daily for five days) with 1531 and 1605 female adults and adolescents with uncomplicated urinary tract infections, respectively. Across both trials, the duration of follow-up for participants was approximately 28 days, and the primary endpoint was the combined clinical and microbiological response at the Test-of-Cure (ToC) visit (days 10-13) in patients with qualifying uropathogens susceptible to nitrofurantoin. EAGLE-1 (non-inferiority urogenital gonorrhoea trial) compared the efficacy and safety of gepotidacin to ceftriaxone plus azithromycin in 628 patients with uncomplicated urogenital gonorrhoea caused by Neisseria gonorrhoeae. About gepotidacin Gepotidacin, discovered by GSK scientists, is an investigational bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct binding site, a novel mechanism of action and for most pathogens, provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most target uropathogens (such as E. coli and S. saprophyticus), and N. gonorrhoeae, including isolates resistant to current antibiotics. Efficacy and safety in patients have been demonstrated in uUTI and gonorrhoea phase III clinical trials, including those with drug-resistant pathogens. Due to the well-balanced inhibition, gepotidacin target-specific mutations in both enzymes are needed to significantly affect susceptibility to gepotidacin. Therefore, leading to a lower potential for resistance development. GSK in infectious diseases GSK has pioneered innovation in infectious diseases for over 70 years, and the Company’s pipeline of medicines and vaccines is one of the largest and most diverse in the industry, with a goal of developing preventive and therapeutic treatments for multiple disease areas or diseases with high unmet needs globally. GSK’s expertise and capabilities in innovation, access and stewardship position the Company uniquely to help prevent and mitigate the challenge of antimicrobial resistance. In antimicrobials, in addition to gepotidacin, GSK entered into an exclusive licence agreement with Spero Therapeutics, Inc. in September 2022 to add tebipenem HBr, a late-stage antibiotic and potential treatment for complicated urinary tract infections (cUTIs), to the pipeline and are currently enrolling for PIVOT-PO, a phase III trial. In March 2023, GSK announced an exclusive licence agreement with Scynexis for Brexafemme (ibrexafungerp tablets), a first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and reduction in the incidence of recurrent VVC. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024. References You might also like

Phase 3License out/inPriority ReviewClinical ResultNDA

10 Oct 2024

·www.gsk.com

GSK and ViiV Healthcare to showcase advances across industry-leading infectious disease portfolio at IDWeek 2024

10 October 2024 60 abstracts to be presented across broad and growing portfolio of vaccines and medicines aimed at getting ahead of infectious disease New data to be shared on GSK’s RSV vaccine across different age groups of patients at increased risk Efficacy data for gepotidacin in patients with a high unmet need suffering from uUTIs to be shared against a backdrop of rising antimicrobial resistance New evidence to be shared on real-world impact of ViiV Healthcare’s innovative, long-acting HIV prevention and treatment portfolio GSK plc (LSE/NYSE: GSK) and ViiV Healthcare will share new data from their industry-leading, prevention-focused infectious disease pipeline and portfolio at the Infectious Disease Society of America’s IDWeek 2024 annual meeting in Los Angeles from 16-19 October 2024. 60 abstracts will be presented, showcasing data for vaccines and medicines across a range of infectious diseases including respiratory syncytial virus (RSV), herpes zoster, uncomplicated urinary tract infections (uUTI) and HIV. Vaccines 22 abstracts from GSK’s vaccines pipeline and portfolio have been accepted, including new data for Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) and Shingrix (Zoster Vaccine Recombinant, Adjuvanted). Presentations on GSK’s RSV vaccine will include data across different age ranges in older adults and post-marketing safety data, plus 10 other abstracts featuring evidence across comorbidities of interest, seasons and geographies. Additional presentations include overviews of GSK's 5-in-1 meningococcal ABCWY vaccine candidate and the risks of invasive meningococcal disease in young children. Medicines Among the abstracts from GSK’s infectious disease therapeutics portfolio, 13 abstracts will highlight data for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for uUTI and urogenital gonorrhoea (GC). This includes an oral presentation of clinical data from the EAGLE-2 and EAGLE-3 phase III trials, examining the efficacy of gepotidacin in patient subgroups with uUTIs with a high unmet need in the context of rising antimicrobial resistance (AMR). Additional data on surveillance and the burden of AMR in uUTIs and treatment failure in uUTIs will also be highlighted. HIV prevention and treatments Additionally, ViiV Healthcare will present 22 abstracts from its innovative HIV treatment and prevention portfolio. Two oral presentations will share real-world evidence from the OPERA and TRIO studies, evaluating the effectiveness of, adherence to and persistence in the use of Apretude (cabotegravir long-acting (LA)) for HIV pre-exposure prophylaxis (PrEP) across diverse populations. Findings from the PILLAR study will highlight the impact of cabotegravir LA for PrEP on common challenges associated with daily oral PrEP, such as stigma and anxiety. Additional abstracts highlight ViiV’s industry-leading long-acting and two-drug regimens for the treatment of HIV including treatment benefits, satisfaction and preference, offering new insights for healthcare providers seeking to optimise care to suit individual needs and circumstances. Tony Wood, Chief Scientific Officer, GSK said: “Infectious diseases represent a major threat to human health, which is why two-thirds of our pipeline focuses on pioneering new technologies to deliver preventative options – like vaccines and HIV PrEP – plus therapeutic solutions. At IDWeek 2024, we’re proud to share data highlighting our scientific developments in the prevention and treatment of diseases like RSV, herpes zoster, uUTI and HIV, while also working to tackle the challenge of antimicrobial resistance.” For more than 70 years, GSK has been advancing a comprehensive portfolio of medicines and vaccines for infectious diseases. Considerable progress has been made, but there remains significant work to do to address the burden of infectious diseases on individuals, society and healthcare systems: More than one billion people are infected annually by seasonal respiratory viruses such as influenza and RSV.1,2 People living with certain underlying health conditions are at increased risk of hospitalisation or death due to RSV.3 About 40 million people live with HIV worldwide, many of whom still face stigma and do not have adequate access to care.4 AMR threatens to undermine the progress that has been made to date and prevent further gains. Without action, AMR could contribute to 40 million deaths by 2050.5 In support of its ambition to get ahead of disease, GSK continues to advance the science, pursuing new solutions while continuing to build the evidence base for its vaccines and treatments. With the breadth of data presented at IDWeek, GSK and ViiV Healthcare highlight their goal to pioneer a new range of first- or best-in-class options to close the gap in prevention and treatment for patients who deserve more. Full list of GSK and ViiV Healthcare’s presentations at IDWeek 2024: GSK in infectious diseases GSK has pioneered innovation in infectious diseases for over 70 years, and the Company’s pipeline of medicines and vaccines is one of the largest and most diverse in the industry, with a goal of developing preventive and therapeutic treatments for multiple disease areas or diseases with high unmet needs globally. With our infectious disease innovation, we’re also helping address the growing number of infections which are resistant to existing medicines. The development of gepotidacin has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C and with federal funds awarded by the Defense Threat Reduction Agency under agreement number HDTRA1-07-9-0002. In antimicrobials, in addition to gepotidacin, GSK entered into an exclusive licence agreement with Spero Therapeutics, Inc. in September 2022 to add tebipenem HBr, a late-stage antibiotic and potential treatment for complicated urinary tract infections (cUTIs), to the pipeline and are currently enrolling for PIVOT-PO, a phase III trial. In March 2023, GSK announced an exclusive licence agreement with Scynexis for Brexafemme (ibrexafungerp tablets), a first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and reduction in the incidence of recurrent VVC. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE), dedicated to delivering advances in treatment and care for people living with HIV and for people who are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q2 Results for 2024. References You might also like

Phase 3License out/inVaccine

03 Oct 2024

·www.globenewswire.com

SCYNEXIS to Present Preclinical Data on Second Generation Fungerp SCY-247 at IDWeek 2024

JERSEY CITY, N.J., Oct. 03, 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 upcoming presentations of preclinical efficacy and pharmacokinetic data on its second-generation fungerp candidate SCY-247 at IDWeek 2024 taking place in Los Angeles, CA from October 16-19, 2024. Presentation details can be found below: Oral Presentation: Title:Efficacy of SCY-247, a Second-generation Triterpenoid Antifungal, in Three Murine Models of Invasive Fungal InfectionsSession:Mycology Matters: Insights into Fungal InfectionsDate/Time:Thursday October 17, 2024 at 10:45 AM PDTLocation:Los Angeles Convention Center, Room 403 BPresenting author:David A. Angulo, M.D., President and CEO of SCYNEXIS Poster Presentation: Title:SCY-247: A Second-generation IV/Oral Triterpenoid Antifungal with Extensive Tissue Distribution and Pharmacokinetics, and Low Drug-Drug Interaction PotentialSession:New Drug DevelopmentDate/Time:Friday October 18, 2024 at 12:15 – 1:30 PM PDTLocation: Los Angeles Convention Center, Halls JKPresenting author:David A. Angulo, M.D., President and CEO of SCYNEXIS For more information, see the IDWeek website here. 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 pre-IND development stage 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 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 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 June 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 RelationsIrina KofflerLifeSci AdvisorsTel: (646) 970-4681ikoffler@lifesciadvisors.com

Fast TrackDrug ApprovalQualified Infectious Disease Product

100 Deals associated with Ibrexafungerp Citrate

External Link

KEGG	Wiki	ATC	Drug Bank
D11544	-	J02AX	DB12471

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Candidiasis, Vulvovaginal	US	SCYNEXIS, Inc.	01 Jun 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Candida Auris Infection	Phase 3	US	SCYNEXIS, Inc.	15 Nov 2017
Candida Auris Infection	Phase 3	IN	SCYNEXIS, Inc.	15 Nov 2017
Candida Auris Infection	Phase 3	PK	SCYNEXIS, Inc.	15 Nov 2017
Candida Auris Infection	Phase 3	ZA	SCYNEXIS, Inc.	15 Nov 2017
Candidemia	Phase 3	US	SCYNEXIS, Inc.	15 Nov 2017
Candidemia	Phase 3	IN	SCYNEXIS, Inc.	15 Nov 2017
Candidemia	Phase 3	PK	SCYNEXIS, Inc.	15 Nov 2017
Candidemia	Phase 3	ZA	SCYNEXIS, Inc.	15 Nov 2017
Aspergillosis, Allergic Bronchopulmonary	Phase 3	US	SCYNEXIS, Inc.	01 Apr 2017
Aspergillosis, Allergic Bronchopulmonary	Phase 3	AT	SCYNEXIS, Inc.	01 Apr 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03672292 (SCYNERGIA, CTgov)	Phase 2	Invasive Pulmonary Aspergillosis	22	Voriconazole+SCY-078 (SCY-078 Plus Voriconazole)	iqnqpqakoj(gbnjsluikz) = veveptpvrn zrvjeuypjn (sgqopnmfgi, niteflwrvp - lqremydvws) View more	-	09 Aug 2024
				Oral Placebo Tablets+Voriconazole (Voriconazole Mono-therapy)	iqnqpqakoj(gbnjsluikz) = zfvsnovjgn zrvjeuypjn (sgqopnmfgi, crfpzlhwvw - llciyucmjf) View more
NCT05399641 (CTgov)	Phase 3	Candidiasis, Vulvovaginal	150	Ibrexafungerp (Group A)	cusldxcpgr(gpkdznhmyx) = cixfxuhknw aivcjtakqn (eihsbqucyu, ydjjmbfirf - kofcannjtc) View more	-	10 Jul 2024
				Ibrexafungerp (Group B (3 Day Dosing))	cusldxcpgr(gpkdznhmyx) = xqfhewbqgk aivcjtakqn (eihsbqucyu, xfjkukizpq - zpxydrepme) View more
NCT02244606 (CTgov)	Phase 2	Candidemia	27	Ibrexafungerp (Ibrexafungerp 500-mg)	cwtegaulxa(byyqmtdqpd) = wrpytsgwjt infyczmbvm (qsoyikxswp, tkwtwpvdoc - hdlzjkyfcv) View more	-	25 Jun 2024
				Ibrexafungerp (Ibrexafungerp 750-mg)	cwtegaulxa(byyqmtdqpd) = gbsndjpare infyczmbvm (qsoyikxswp, seuqdjlzsn - dpigeagwpd) View more
NCT04029116 (CANDLE, CTgov)	Phase 3	Candidiasis, Vulvovaginal	440	Fluconazole Tablet+IBREXAFUNGERP (Ibrexafungerp)	knpldcipwt(pcgdwvcugy) = ebhahsrjii klammxllgv (pclofheflb, zbmfgarasf - gcelxcnztu) View more	-	18 Jun 2023
				Placebo oral tablet+Fluconazole Tablet (Placebo)	knpldcipwt(pcgdwvcugy) = csojppcebk klammxllgv (pclofheflb, zqlztsoojj - opxxflypbz) View more
NCT03734991 (VANISH 303 and VANISH 306, Pubmed)	Phase 3	Candidiasis, Vulvovaginal	376	Ibrexafungerp 300mg BID	dbruboqdji(xrmarauuqo) = zkagmhvbpz ljamqtthaw (nzzdzkhesn ) View more	-	17 Oct 2022
				Placebo	dbruboqdji(xrmarauuqo) = dcczpvxynj ljamqtthaw (nzzdzkhesn ) View more
NCT03363841 (CARES, Biospace) Manual	Phase 3	Candidiasis	18	Ibrexafungerp	myecmsugrd(ebkgmkhlfp) = mebuggnayb cfjrclocwf (yfzorifpbm ) View more	Positive	08 Sep 2022
NCT03059992 (FURI, Biospace) Manual	Phase 3	Candidiasis	64	Ibrexafungerp	kgsshubphy(wacitohudd) = geiyrolxdl smtmghjziw (qxexxcydhp ) View more	Positive	08 Sep 2022
				Ibrexafungerp (refractory vulvovaginal candidiasis (VVC) cases)	ynyrutflkb(hzxryhbcjb) = uogpimdpnz tlopvnnkpi (zntawoecji ) View more
NCT04029116 (CANDLE, GlobeNewswire) Manual	Phase 3	Candidiasis, Vulvovaginal	24	ibrexafungerp	fnibaguzyc(gdanstydpe) = gehwsvppmm pruxxgmaup (vggrozrcdd ) View more	Positive	19 Jul 2022
NCT03059992 (FURI, GlobeNewswire) Manual	Phase 3	Candidiasis, Vulvovaginal	14	Ibrexafungerp	tlbeuxyabb(bhmawhkxsw) = ckwdzhkvhj vxkaqqrnin (ivlvnserty )	Positive	10 May 2022

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis