A Phase 1b, Single Arm, Multi-center, Open-label, Dose-escalation Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients with Invasive Fungal Infection - nil

Start Date11 Jul 2024

Sponsor / Collaborator

Biosergen AS

[+1]

NCT06678113

/ RecruitingPhase 1/2

A Phase 1b, Single Arm, Multi-center, Open-label, Dose-escalation Study to Assess the Safety and Efficacy of Intravenous BSG005 in Patients with Invasive Fungal Infection

This study is an open-label, Phase 1b, dose-escalation/finding study to assess the safety and efficacy of intravenous BSG005 in patients with uncomplicated invasive fungal infections (IFI).
Approximately 15 patients are planned to be enrolled in 3 cohorts. The study will be conducted in 3 cohorts consisting of 3 periods, namely: Screening, Treatment, and Follow-up periods. In each cohort, 5 patients are planned to be enrolled.
This study is a single-arm study. The treatment (BSG005) in each dose level will be administered once daily for 3 days via IV infusion. If the safety and tolerability profiles are acceptable at each dose level, the patients will be treated for a maximum of 28 days. Each patient will be in the study for up to 50 days, which consists of a 7-day Screening period, 1 day for baseline assessments, up to 28 days (maximum) of treatment with BSG005, and 14 days of follow-up.

Start Date01 Jul 2024

Sponsor / Collaborator

Biosergen AS

[+1]

NCT04921254

/ Unknown statusPhase 1

A Phase 1, Double-blinded, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of BSG005 Following Single and Multiple Ascending Doses in Healthy Subjects

A Phase 1, double-blinded, placebo-controlled study to assess the safety, tolerability, and pharmacokinetics of BSG005 following single and multiple ascending doses in healthy subjects. The study will include a single ascending dose part and a multiple ascending dose part

Start Date23 Aug 2021

Sponsor / Collaborator

Biosergen AS

[+3]

100 Clinical Results associated with BSG-005

100 Translational Medicine associated with BSG-005

100 Patents (Medical) associated with BSG-005

Literatures (Medical) associated with BSG-005

05 Dec 2024·Antimicrobial Agents and Chemotherapy

In vivo pharmacodynamic evaluation of the novel nystatin derivative BSG005 in the invasive candidiasis and invasive pulmonary aspergillosis mouse models

Article

Author: Zarnowski, Robert ; Massey, Justin ; Andes, David R. ; Jones, Ryley ; Lepak, Alexander J. ; Olesen, Tine K.

ABSTRACT Nystatin, a polyene, is one of the oldest antifungal drugs with wide in vitro potency. BSG005 is a novel, chemically modified, nystatin-like molecule in development for systemic therapy. We evaluated the pharmacokinetic/pharmacodynamic (PK/PD) relationships and target exposures using in vivo invasive pulmonary aspergillosis (IPA) and invasive candidiasis (IC) infection models for BSG005 against common fungal pathogens including Aspergillus fumigatus , Candida albicans , Candida auris , and Candida glabrata . For each species group, three to four strains were selected. Minimum inhibitory concentration (MIC) testing was done by Clinical Laboratory Standards Institute (CLSI) methods. Single-dose kinetics for BSG005 were performed at four dose levels. The immunosuppressed mouse IPA model was used for A. fumigatus studies. For all Candida studies, we utilized the neutropenic disseminated candidiasis model. We used quantitative PCR to enumerate Aspergillus in the lung and colony forming units (CFU) counts for Candida in the kidney. Treatment results were evaluated based on both area under the concentration-time curve (AUC)/MIC and maximum plasma concentration ( Cmax )/MIC exposures. The BSG005 MIC was 1 mg/L against all strains. Escalating doses of BSG005 resulted in increased effect and, in general, the dose-response curves within each species were concordant. The median 96-h AUC/MIC associated with net stasis was lowest at 6.08 for C. glabrata . Increasing exposures were needed for same outcome for C. auris at 18.7, C. albicans at 29.3, and A. fumigatus at 102.4. Cmax /MIC targets for the four groups were 0.22, 0.48, 0.60, and 1.41. BSG005 demonstrated potent activity against a variety of fungal pathogens in the neutropenic mouse models. Cmax /MIC PK/PD targets were numerically lower than other polyene studies using the same infection models.

01 Aug 2023·Advanced Drug Delivery Reviews

Reviving the interest in the versatile drug nystatin: A multitude of strategies to increase its potential as an effective and safe antifungal agent

Review

Author: Nascimento, Cecília ; Reis, Salette ; Sousa, Filipa ; Ferreira, Domingos ; Costa, Paulo

Nystatin is an antifungal molecule with a remarkable yet squandered versatility. In this review, its mechanism of action is explored, along with its extensive action spectrum and toxicity. A multitude of methodologies to tackle the drug's physical and chemical hurdles are outlined along with some proven-effective strategies to increase its activity and/or decrease its toxicity. A separate detailed section focused on micro and nanotechnology solutions addresses new drug delivery systems made of polymeric, metallic or lipid materials. Although the topical route depicts greater representativeness amongst these formulations, the intravenous, dental, oral, vaginal and inhalation routes are also mentioned. The unsuccessful previous attempts at developing parenteral formulations of nystatin or even the withdrawal of a nystatin-loaded multilamellar liposome should not divert research away from this drug. In fact, the interest in nystatin ought to be reawakened with the ongoing clinical trials on the promising nystatin-like genetically engineered derivate BSG005.

01 Nov 2008·Chemistry & Biology

Improved Antifungal Polyene Macrolides via Engineering of the Nystatin Biosynthetic Genes in Streptomyces noursei

Article

Author: Trond E. Ellingsen ; Trygve Brautaset ; Sven Even F. Borgos ; Ingrid Bakke ; Kristin F. Degnes ; Sergey B. Zotchev ; Alexander Dikiy ; Håvard Sletta ; Ivan D. Treshalin ; Aina Nedal ; Elena P. Mirchink ; Olga Volokhan ; Olga N. Sekurova

Seven polyene macrolides with alterations in the polyol region and exocyclic carboxy group were obtained via genetic engineering of the nystatin biosynthesis genes in Streptomyces noursei. In vitro analyses of the compounds for antifungal and hemolytic activities indicated that combinations of several mutations caused additive improvements in their activity-toxicity properties. The two best analogs selected on the basis of in vitro data were tested for acute toxicity and antifungal activity in a mouse model. Both analogs were shown to be effective against disseminated candidosis, while being considerably less toxic than amphotericin B. To our knowledge, this is the first report on polyene macrolides with improved in vivo pharmacological properties obtained by genetic engineering. These results indicate that the engineered nystatin analogs can be further developed into antifungal drugs for human use.

News (Medical) associated with BSG-005

10 Jun 2021

·www.globenewswire.com

Karolinska Development’s portfolio company Biosergen raises SEK 50 million through a successful unit offering and prepares for IPO

STOCKHOLM, SWEDEN – June 10, 2021. Karolinska Development AB (Nasdaq Stockholm: KDEV) announces today that its portfolio company Biosergen has completed a successful and fully subscribed unit offering bringing the company SEK 50 million and that Biosergen’s share will be listed on Nasdaq First North Growth Market in Stockholm on June 24, 2021. The proceeds from the offering allow Biosergen to launch clinical trials of its antifungal drug candidate BSG005 with the ambition of filing for market approval in the United States and Europe by the end of 2025. Biosergen develops BSG005, an antifungal drug candidate which has demonstrated a wide spectrum of antimycotic effects in several preclinical experimental models. To date, fungal infections cause more than 1.5 million deaths annually around the world, derived from systemic infections occurring in both natural environments and in hospitals. By addressing the sizeable need for new and effective antifungals, Biosergen is targeting a market with an estimated value of USD 16.7 billion. As a result of the successful unit offering, Biosergen will now list the company’s share on Nasdaq First Growth Market and take the next step in the development of BSG005 in an effort to challenge the status quo in the antifungal market. “Based on the positive and robust results shown by BSG005 in the preclinical trials it is a natural next step to advance into human clinical trials. We are happy to be onboard with Biosergen as they go through the IPO and broaden their shareholder’s base in the effort to meet the global need for new and effective antifungals,” comments Karolinska Development's CEO, Viktor Drvota. Karolinska Development has interest in Biosergen through KDev Investment’s holdings of 3.2% of the outstanding shares in Biosergen. For further information, please contact: Viktor Drvota, CEO, Karolinska Development AB Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com Johan Dighed, General Counsel and Deputy CEO, Karolinska Development ABPhone: +46 70 207 48 26, e-mail: johan.dighed@karolinskadevelopment.com TO THE EDITORS About Karolinska Development ABKarolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients' lives while providing an attractive return on investment to shareholders. Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success. Karolinska Development has a portfolio of ten companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases. The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network. For more information, please visit . Attachment

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100 Deals associated with BSG-005

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Indication	Highest Phase	Country/Location	Organization	Date
Invasive Fungal Infections	Phase 2	India	Biosergen AS	01 Jul 2024
Mycoses	Phase 1	Australia	Biosergen AS	19 Apr 2022

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