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Biotron Ltd. is a clinical stage biotechnology firm that specializes in developing and commercializing a groundbreaking small molecule treatment for serious viral diseases. The company's innovative technology focuses on viroporin proteins, which play a crucial role in the pathogenicity of various viruses such as hepatitis C, HIV-1, Dengue, Zika, Influenza, and respiratory syncytial virus. Biotron's unique bacterial cell-based screening platform allows for rapid identification of target viroporin proteins. Established in February 1999, the company is headquartered in North Ryde, Australia.

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A Phase 2 Study of BIT225, an HIV-1 Vpu Inhibitor, in HIV-1 Infected, Treatment Experienced Individuals, Attaining Only Partial Immune Reconstitution on a Durable, Suppressive Combination Antiretroviral Therapy (cART) Regimen: An Open-Label Exploratory Evaluation of Changes in Inflammatory, Immune, Immune Activation and Viral Markers.

Start Date10 Jan 2022

Sponsor / Collaborator

Biotron Ltd.

ACTRN12621000937819 / Active, not recruitingPhase 2

A Phase 2 Study of BIT225, a Human Immunodeficiency Virus-1 (HIV-1) Vpu Inhibitor, in Treatment Naive HIV-1 Infected Individuals Commencing Dolutegravir-based Combination Antiretroviral Therapy (cART): Evaluation of Safety, Efficacy and Inflammatory and Immune Activation Markers.

Start Date16 Nov 2021

Sponsor / Collaborator

Biotron Ltd.

100 Clinical Results associated with Biotron Ltd.

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0 Patents (Medical) associated with Biotron Ltd.

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9

Literatures (Medical) associated with Biotron Ltd.

01 Aug 2023·PLoS pathogens

Post-infection treatment with the E protein inhibitor BIT225 reduces disease severity and increases survival of K18-hACE2 transgenic mice infected with a lethal dose of SARS-CoV-2.

Article

Author: Bobardt, Michael ; Miller, Michelle ; Rosenkilde, Mette M ; Thomson, Audrey ; Bentzen, Bo Hjorth ; Klumpp, Klaus ; Becker, Stephen ; Yan, Yannan ; Gallay, Philippe ; Ewart, Gary

The Coronavirus envelope (E) protein is a small structural protein with ion channel activity that plays an important role in virus assembly, budding, immunopathogenesis and disease severity. The viroporin E is also located in Golgi and ER membranes of infected cells and is associated with inflammasome activation and immune dysregulation. Here we evaluated in vitro antiviral activity, mechanism of action and in vivo efficacy of BIT225 for the treatment of SARS-CoV-2 infection. BIT225 showed broad-spectrum direct-acting antiviral activity against SARS-CoV-2 in Calu3 and Vero cells with similar potency across 6 different virus strains. BIT225 inhibited ion channel activity of E protein but did not inhibit endogenous currents or calcium-induced ion channel activity of TMEM16A in Xenopus oocytes. BIT225 administered by oral gavage for 12 days starting 12 hours before infection completely prevented body weight loss and mortality in SARS-CoV-2 infected K18 mice (100% survival, n = 12), while all vehicle-dosed animals reached a mortality endpoint by Day 9 across two studies (n = 12). When treatment started at 24 hours after infection, body weight loss, and mortality were also prevented (100% survival, n = 5), while 4 of 5 mice maintained and increased body weight and survived when treatment started 48 hours after infection. Treatment efficacy was dependent on BIT225 dose and was associated with significant reductions in lung viral load (3.5 log10), virus titer (4000 pfu/ml) and lung and serum cytokine levels. These results validate viroporin E as a viable antiviral target and support the clinical study of BIT225 for treatment and prophylaxis of SARS-CoV-2 infection.

04 Jun 2021·The Journal of Infectious Diseases

Human Immunodeficiency Virus Type 1 Vpu Inhibitor, BIT225, in Combination with 3-Drug Antiretroviral Therapy: Inflammation and Immune Cell Modulation

Article

Author: Avihingsanon, Anchalee ; Murphy, Robert L ; Luscombe, Carolyn A ; Han, Win Min ; Gatechompol, Sivaporn ; Becker, Stephen ; Miller, Michelle ; Supparatpinyo, Khuanchai ; Ewart, Gary D ; Thomson, Audrey S

AbstractBIT225 is a first-in-class inhibitor of human immunodeficiency virus (HIV) type 1 Vpu. A phase II trial enrolled 36 HIV-1–infected, treatment-naive participants in Thailand to receive standard-of-care antiretroviral therapy (ART), tenofovir disoproxil fumarate/emtricitabine/efavirenz (Atripla), with 100 or 200 mg of BIT225 or placebo (daily) for 12 weeks. Combined treatment with BIT225 and ART was found to be generally safe and well tolerated, with antiviral efficacy comparable to that of ART alone. The secondary end point—soluble CD163, a marker of monocyte/macrophage inflammation—was noted to be significantly decreased in the BIT225 arm. Plasma-derived activated CD4+ and CD8+ T cells, natural killer cells, and interleukin 21 were increased in those treated with BIT225. These findings are consistent with inhibition of the known effects of HIV Vpu and may reflect clinically important modulation of inflammatory and immune function. Further clinical study is planned to both confirm and extend these important findings in treatment-naive, and treatment-experienced individuals.Clinical Trials Registration. Australian New Zealand Clinical Trials Registry (Universal Trial Number U1111-1191-2194).

01 Dec 2016·AIDS Research and TherapyQ4 · MEDICINE

The antiviral compound BIT225 inhibits HIV-1 replication in myeloid dendritic cells

Q4 · MEDICINE

ArticleOA

Author: Wilkinson, John ; Ewart, Gary ; Luscombe, Carolyn ; Khoury, Gabriela ; Miller, Michelle

BACKGROUNDPrevious studies with BIT225 (N-carbamimidoyl-5-(1-methyl-1H-pyrazol-4-yl)-2-naphthamide) have demonstrated a unique antiviral activity that blocks the release of HIV-1 from monocyte-derived macrophages (MDM). Antagonising the ion channel formed by HIV-1 Vpu, BIT225 preferentially targets de novo intracellular virus produced in 'virus-containing compartments' of MDM. In primary infections, dendritic cells (DC) are one of the first cells infected by HIV-1 and can transfer virus to more permissive CD4(+) T cells, making these cells an important target for novel antiviral therapies. To extend previous findings with BIT225, we aimed to further characterise the antiviral activity of BIT225 on HIV-1 replication in monocyte-derived DC (MDDC).RESULTSThe anti-HIV-1 activity of BIT225 was evaluated in vitro within MDDC alone and in co-cultures with activated CD4(+) T cells to examine the effect of the drug on HIV-1 transfer. Antiviral activity was determined by measuring HIV-1 reverse transcriptase activity in the culture supernatant of BIT225 treated and DMSO control cultures. A single dose of BIT225 resulted in a mean (SE) peak inhibition of HIV-1 release from MDDC by 74.5 % (±0.6) following 14 days of culture and a 6-fold reduction of HIV-1 transfer to activated uninfected CD4(+) T cells in co-culture.CONCLUSIONSHIV-1 release from MDDC was inhibited by BIT225. This data broadens the drug's antiviral activity profile within cells of the myeloid lineage. These findings suggest a potential role for BIT225 in reducing HIV-1 production and preventing viral dissemination in early and chronic infection and may assist in limiting virus spread with any ongoing viral replication during antiretroviral therapy.

100 Deals associated with Biotron Ltd.

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100 Translational Medicine associated with Biotron Ltd.

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Pipeline

Pipeline Snapshot as of 19 Dec 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

4

3

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Ebola/SARs(Biotron)	Severe Acute Respiratory Syndrome More	Preclinical
Dengue(Biotron)	Dengue More	Preclinical
Influenza(Biotron)	Influenza, Human More	Preclinical
Zika(Biotron)	Zika Virus Infection More	Preclinical
Etanercept biosimilar(Biotron Ltd.) ( LTα x TNF-α )	Rheumatoid Arthritis More	Pending