Basilea initiated a Phase 3 clinical trial of anti-pilling epigenetics in candidemia and invasive candidiasis

Allschwil, September 24, 2024

Basilea Pharmaceutica AG, Allschwil (SIX: BSLN), a biopharmaceutical company that markets products and products that can help patients die from infections by the bacteria or pills that are being developed, because they can quickly undergo a phase 3 study -IC (Fosmanogepix Against Standard-of-care Treatment in Invasive Candidiasis) initiated. In these relevant studies on the investigation and protection of the Basilea’s broad spectrum anti-pill Fosmanogepix in the treatment of adult patients and patients with candidiasis and/or invasive candidiasis unstudied, with bloodstream infections or deep-seated web infections through Candida-Hefepilze.¹

Fosmanogepix is ​​a drug candidate for the treatment of pill injection with a new substance class and with a new artificial mechanism of action. There is an intravenous and oral formulation that consists of a phase 1/phase 2 program based on research and investigation, another in three open-label phase 2 study for the treatment of candidaemia (blood flow infections with Candida-Hefepilzen), last but not least, die durch Candida infection care should be taken, and for the treatment of invasive fungal infections.^{2, 3, 45}

Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “We will be conducting further studies in the Phase 3 program for Fosmanogepix so that patient recruitment for the FAST-IC study can begin. Invasive Candida-Infections are for many Krankenhaus patients with serious complications, which can occur with a high rate of cure, and a fosmanogepix may offer a new new treatment option in those cases with better medical treatment. There have been started a few years ago to end the phase 3 study for starting a Fosmanogepix, and the treatment will lead to patients and patients with invasive fungal infections.”

FAST-IC is a global, multicenter, randomized, active-controlled, double-blind phase 3 study, in the intravenous (iv) verabreichte fosmanogepix in the representation of a standard treatment with caspofungin. v. in adult Patients and patients with Candidämia and/or invasive Candidiasis was investigated. During the study, 450 patients and patients were treated, who were randomly mixed 2:1 with fosmanogepix or caspofungin. It is the best option to use the oral solution, and in the Fosmanogepix group to use the oral formulation of Fosmanogepix and in the Caspofungin group to use oral fluconazole. The Phase 3 program was performed in the Schweiz project, but it was a good idea to operate by PSI CRO AG.

Basilea hat Fosmanogepix in November 2023 from Amplyx Pharmaceuticals, Inc., a Tochtergesellschaft from Pfizer Inc. erworben. In the Rahmen der Kaufvereinbarung (Asset Purchase Agreement), Basilea will receive all rights and obligations under the terms of the purchase agreement and will receive the first patients in the study with a payment of USD 6.0 million. slates. This financial assessment is fully informed by the financial forecast of Basilea for the future 2024.

This project is being carried out by the Bundesmitteln des US-Gesundheitsministeriums (HHS), Administration for Strategic Preparedness and Response (ASPR), Biomedical Advanced Research and Development Authority (BARDA), funded under OT number 75A50124C00033. The Vereinbarung and the Finanzierung by the American Bundesmittel do not support study or research activities for the product or the company.

About Fosmanogepix

Fosmanogepix is ​​​​an anti-fungal agent in the clinical pulmonary phase. A new art mechanism and an active file have been found that can be used to make art Candida and Aspergillus erwiesen, dare to make a multi-resistant strain Candida infection and Candida glabrata so who is seltene, schwer zu treated Schimmelpilze who Fusarium species, Scedosporium spp. and a beer from the order of the mucorales.² The intravenous and oral formulations of Fosmanogepix are being administered during Phase 2 clinical trials for the treatment of stroke infections during treatment Candida-Lift, separately Candida infectionand invasive fungal infections derived.² Fosmanogepix from the US-American Food and Drug Administration (FDA) for Fast-track and Orphan Drug Status indications to maintain Qualified Infectious Disease Product (QIDP) status.

Extremely invasive Schimmelpilzinfektion

Invasive Aspergillosis and invasive infections with seltene Schimmelpilzen (z. B. Fusarium species, Scedosporium spp. and Mucorales-Pilzen) as serious infections, which cause all immune diseases of patients and patients, can be solved with Blutkrebs, Transplant patients or Patients with other Immunological Diseases. These infections can have a high morbidity and serious consequences.^{6, 7}

About invasive infections with Candida-Hefepilzen (Candidiasis)

Invasive candidiasis, one of the most common infections of candidiasis and candidemia (Candida-Bloodstream infection), is one of the most commonly used Spital infections, especially in patients and patients who are studied in intensive care units. Candida-Arten sind in de USA die vierthäufigste Ursache für Blutstrominfektionen in Spitälern.⁸ The prognosis of invasive candidiasis is not so long, and the mortality rate is 40% of reports, even if the patient receives antifungal therapy.⁹

About Basilica

Basilea is a year ago in the year 2000 with Hauptsitz in the Schweiz gefoundedtes biopharmaceutical company with ready marketed products. There are more and more innovative medicines for the development, the sale and the sale of patients, which make an infection by the bakery or the pill possible. With Cresemba and Zevtera many medicines for the Einsatz in the Spital have been brought on the Market: Cresemba for the treatment of invasive Pill infections and Zevtera for the Treatment of bakery infections. You can consult a portfolio with clinical and clinical anti-infective programs. Basilea is one of the Swiss Stock Exchange SIX Swiss Exchange-kürzel (Börsenkürzel SIX: BSLN). Please visit our website basilicumea.com.

Exclusion class

This Mitteilung is extended or implied zukunftsgerichtte Aussagen with “glauben”, “annehmen”, “erwarten”, “prognostizieren”, “planen”, “können”, “konnten”, “werden” or ähnliche Ausdrücke regarding Basilea Pharmaceutica AG, Allsch wants and your Geschäftsaktivitäten, ua in Bezug auf de Fortschritt, het Zeitplan und de Abschluss von Forschung und Entwicklung who conduct clinical research with product candidates. Solche may engage in expanding the risks and uncontrolled factors, which will do the following things, the financial low costs, the financing or the operation of Basilea Pharmaceutica AG, which will provide the whole world with financing targeted Aussagen hervorgehen. This document is dated as of the latest. Basilea Pharmaceutica AG, however, assumes no obligation whatsoever to update future publications in the event of new information, future events or other grounds.

For further information please contact:

This press conference will take place at www.basilea.com.

Sources

1. ClinicalTrials.gov Identifier: NCT05421858
2. KJ Shaw, AS Ibrahim. Fosmanogepix: a review of the first-in-class broad-spectrum agent for the treatment of invasive fungal infections. Journal of Fungi (Basel) 2020 (6), 239
3. MR Hodges, E. Ople, P. Wedel et al. Safety and pharmacokinetics of intravenous and oral fosmanogepix, a first-in-class antifungal agent, in healthy volunteers. Antimicrobial Agents and Chemotherapy 2023 (67), e01623-22
4. JA Vazquez, PG Pappas, K. Boffard et al. Clinical efficacy and safety of a novel antifungal agent, Fosmanogepix, in patients with candidemia caused by Candida auris: results of a phase 2 study. Antimicrobial Agents and Chemotherapy2023 (67), e01419-22
5. PG Pappas, JA Vazquez, I. Oren et al. Clinical safety and efficacy of the novel antifungal agent, fosmanogepix, for the treatment of candidemia: results of a phase 2 study. Journal of Antimicrobial Chemotherapy 2023 (78), 2471-2480
6. J. Cadena, GR Thompson 3rd, TF.Patterson. Aspergillosis: epidemiology, diagnosis and treatment. Infectious Disease Clinics of North America 2021 (35), 415-434
7. M. Slavin, S. van Hal, TC Sorrell et al. Invasive infections by filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10
8. Candidaemia (blood infection) and other Candida infections. American Thoracic Society 2019 fact sheet: https://www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (Zugriff on September 23, 2024)
9. BJ Kullberg, MC Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456

• Press release (PDF).pdf