Medical Mycology

Mundipharma and Cidara Therapeutics receive positive CHMP opinion for rezafungin for the treatment of Invasive Candidiasis in adults1

Retrieved on: 
Friday, October 13, 2023
Health, Infectious Diseases, Other Science, Clinical Trials, Science, Pharmaceutical, Biotechnology, European, Multimedia, Infection, Restore, Committee for Medicinal Products for Human Use, CHMP, Fungal infection, European Medicines Agency, CDTX, Mortality, European Commission, Safety, Disease, EMA, Medical Mycology, FDA, Therapy, Phase, EC, Mycology, Committee, News, Candidiasis, Civil service commission, Caspofungin, Patient, Vaccine, Pharmaceutical industry, Mundipharma

Mundipharma and Cidara Therapeutics (Nasdaq: CDTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.1

Key Points: 
  • Mundipharma and Cidara Therapeutics (Nasdaq: CDTX) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for rezafungin (rezafungin acetate) for the treatment of invasive candidiasis in adults.1
    This press release features multimedia.
  • A new treatment option for these serious infections is a much-needed addition.”
    “We would like to thank the CHMP for their careful consideration of the use of rezafungin.
  • The CHMP’s positive opinion on rezafungin for the treatment of serious fungal infections, such as invasive candidiasisin adults, will be referred to the European Commission (EC), which will deliver a final decision in approximately two months.
  • Cidara Therapeutics has partnered with Mundipharma, which has commercial rights to rezafungin outside the U.S. and Japan.

Innovation Pharmaceuticals Brilacidin Antifungal Research Published in Nature Communications

Retrieved on: 
Monday, April 17, 2023
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WAKEFIELD, MA, April 17, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced publication of Brilacidin antifungal research in Nature Communications, a leading peer-reviewed scientific journal.

Key Points: 
  • WAKEFIELD, MA, April 17, 2023 (GLOBE NEWSWIRE) -- via NewMediaWire -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announced publication of Brilacidin antifungal research in Nature Communications, a leading peer-reviewed scientific journal.
  • The paper, discussing combinations of Brilacidin and other antifungal drugs toward improving treatment outcomes in fungal infections, is available at the link below:
    dos Reis, T.F., de Castro, P.A., Bastos, R.W.
  • A host defense peptide mimetic, brilacidin, potentiates caspofungin antifungal activity against human pathogenic fungi .
  • He is an expert in fungal genetics and antifungal resistance and his laboratory at USP focuses on the molecular biology of human fungal pathogens.

NEW RESEARCH PAPER SUPPORTS USING MICROBIOME DATA TO DEVELOP POTENTIAL PROBIOTIC THERAPIES

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Thursday, January 26, 2023
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CLEVELAND, Jan. 26, 2023  /PRNewswire/ -- In a new paper, published Jan. 25, 2023, online by the journal Gastroenterology, researchers from University Hospitals (UH) Cleveland Medical Center and Case Western Reserve University School of Medicine, review studies about the microbiome's role in disease and health, and discuss tactics for developing probiotics to modulate the microbiome through leveraging microbiome data. They illustrate these tactics by using Crohn's disease (CD) as an example.

Key Points: 
  • The comprehensive intestinal microbiome, representing bacterial and fungal communities, profiles were assessed at the start of the study and following four weeks of probiotic consumption.
  • Through the analysis of big microbiome data sets, researchers have started to appreciate the microbiome composition differences between different cohorts of individuals.
  • That has lead to the opportunity to leverage such data insights for targeted microbiome solution development.
  • The probiotic formulation developed through this data-powered design process was launched in market by BIOHM Health Inc. as a general wellness probiotic.

SCYNEXIS Announces $3 Million National Institutes of Health Grant Has Been Awarded to Case Western Reserve University Researchers to Study Second Generation Fungerp (SCY-247) to Fight Drug-Resistant Fungi

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Wednesday, November 30, 2022
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We congratulate Dr. Ghannoum on receiving this grant and want to express our gratitude for his ongoing commitment to patients suffering from terrible and deadly fungal infections.

Key Points: 
  • We congratulate Dr. Ghannoum on receiving this grant and want to express our gratitude for his ongoing commitment to patients suffering from terrible and deadly fungal infections.
  • C. auris has emerged in recent years as a global threat causing serious invasive infections with mortality as high as 60 percent worldwide.
  • The World Health Organization (WHO) recently released its first ever fungal priority pathogens list (FPPL), which includes C. auris in the critical priority group.
  • In addition, late-stage clinical investigation of ibrexafungerp for the treatment of life-threatening invasive fungal infections in hospitalized patients is ongoing.

SCYNEXIS Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Corporate Update

Retrieved on: 
Tuesday, March 29, 2022
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Based on cash balance at December 31, 2021 and operating plan, SCYNEXIS has a projected cash runway into the second quarter of 2023.

Key Points: 
  • Based on cash balance at December 31, 2021 and operating plan, SCYNEXIS has a projected cash runway into the second quarter of 2023.
  • BREXAFEMME delivered $0.6 million in net sales in fourth quarter 2021 and $1.1 million in total net sales in 2021.
  • Research and development expense for the fourth quarter of 2021 decreased to $7.7 million from $10.2 million versus the fourth quarter of 2020.
  • Selling, general& administrative (SG&A) expense for the fourth quarter of 2021 increased to $15.0 million from $5.2 million versus the fourth quarter of 2020.

Cidara Provides Corporate Update and Reports Third Quarter 2021 Financial Results

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Wednesday, November 10, 2021
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SAN DIEGO, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today reported financial results for the third quarter ended September30, 2021 and provided an update on its corporate activities and product pipeline.

Key Points: 
  • SAN DIEGO, Nov. 10, 2021 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today reported financial results for the third quarter ended September30, 2021 and provided an update on its corporate activities and product pipeline.
  • We are pleased to report another highly productive quarter for Cidara, said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara.
  • The gross proceeds to Cidara from these offerings, before deducting underwriting discounts and commissions and estimated offering expenses, were approximately $38.5 million.
  • Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

SCYNEXIS Announces Preclinical Data at the 10th Trends in Medical Mycology Meeting Supporting Potential of Ibrexafungerp to Treat Mucormycosis

Retrieved on: 
Monday, October 11, 2021
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The data, based on an in vivo mouse model of mucormycosis, were presented at the 10th Trends in Medical Mycology (TIMM) meeting being held in-person in Aberdeen, Scotland, and virtually from October 8-11, 2021.

Key Points: 
  • The data, based on an in vivo mouse model of mucormycosis, were presented at the 10th Trends in Medical Mycology (TIMM) meeting being held in-person in Aberdeen, Scotland, and virtually from October 8-11, 2021.
  • Cases of mucormycosis have increased significantly during the COVID-19 pandemic and the Central Government of India declared mucormycosis an epidemic on May 10, 2021.
  • "Im encouraged by the findings from this study which demonstrate the potential for a new antifungal class to treat mucormycosis.
  • I believe this work lays a strong foundation for future studies evaluating ibrexafungerps potential to combat this often-lethal infection.

Introducing a New Antifungal Surveillance Program: Analysis of Resistance to Antifungals (ARIA) and Expanded Mycology Services at IHMA

Retrieved on: 
Thursday, October 7, 2021
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International Health Management Associates (IHMA) has initiated a new antifungal resistance surveillance program, Analysis of Resistance to Antifungals (ARIA) to further the development of new antifungal agents and monitor the development of antifungal resistance.

Key Points: 
  • International Health Management Associates (IHMA) has initiated a new antifungal resistance surveillance program, Analysis of Resistance to Antifungals (ARIA) to further the development of new antifungal agents and monitor the development of antifungal resistance.
  • IHMA offers an option for biopharmaceutical companies to add new antifungal agents to the program.
  • The first presentation of ARIA data - Analysis of Resistance In Antifungals (ARIA) - Global Surveillance of Candida spp.
  • Isolates, Including C. auris, in 2019 - will be made at the upcoming 10th Trends in Medical Mycology (TIMM-10), 8-11 October 2021, Aberdeen, Scotland.

SCYNEXIS to Present Clinical Data from Ongoing FURI and CARES Studies at the 10th Trends in Medical Mycology Meeting Showing Oral Ibrexafungerp Provides a Favorable Therapeutic Response in Patients with Severe Fungal Infections

Retrieved on: 
Thursday, October 7, 2021
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In addition, pre-clinical data on ibrexafungerp for the treatment of mucormycosis will be shared in an oral presentation.

Key Points: 
  • In addition, pre-clinical data on ibrexafungerp for the treatment of mucormycosis will be shared in an oral presentation.
  • There are limited oral options effective against multidrug-resistant pathogens in the hospital setting, said David Angulo, M.D., Chief Medical Officer, SCYNEXIS.
  • We hope to address this unmet need by advancing oral ibrexafungerp through these studies.
  • It is part of our ongoing commitment to patients in the hospital setting, who are battling invasive and sometimes fatal fungal infections.

Cidara Therapeutics to Present New Data for Rezafungin at TIMM Congress

Retrieved on: 
Wednesday, September 29, 2021
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Rezafungin is a novel once-weekly echinocandin currently being studied in Phase 3 trials for the treatment and prevention of serious fungal infections, including incriticallyill patients.

Key Points: 
  • Rezafungin is a novel once-weekly echinocandin currently being studied in Phase 3 trials for the treatment and prevention of serious fungal infections, including incriticallyill patients.
  • Title: Evaluation of the Post-Antifungal Effect of Rezafungin and Micafungin against Candida albicans, Candida parapsilosis, and Candida glabrata
    Additional details can be found on the TIMM website here .
  • Rezafungin is a novel once-weekly echinocandin being developed for both the treatment and prevention of serious fungal infections, such as candidemia and invasive candidiasis.
  • Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases.