Biotron secures approval to carry out antiviral drug trial at more sites

Tuesday, March 11, 2014 by Proactive Investors

Biotron (ASX: BIT) has received ethics approval from Khon Kaen University for additional sites to carry out the ongoing phase 2 trial of its lead antiviral drug, BIT225, in patients co-infected with HIV and Hepatitis C virus (HCV).

The company now has approval to carry out the trial in Chiang Mai and an additional site in Bangkok.

These new sites in Chiang Mai and Bangkok are expected to initiate and then commence screening and enrolment over the next fortnight.

The study is a placebo controlled, double blind study of BIT225 in 60 patients infected with HCV genotypes 1 or 3.

Trial participants will receive 12 weeks of 200 mg BIT225 or placebo, dosed twice daily, in combination with current standard of care therapies - pegylated interferon alfa 2b (IFN) and ribavirin (RBV).

On completion of dosing with BIT225, they will remain on IFN/RBV for an additional 12 weeks (genotype 3) or 36 weeks (genotype 1).

The trial has been designed to generate safety and efficacy data on BIT225 over an extended treatment period.

Previous studies have shown BIT225 to be safe and well tolerated over a 28 day dosing period, with positive efficacy data in patients infected with HCV genotypes 1 and 3, as well as in HIV/HCV co-infected patients.

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BIT225 HIV/HCV Trial Patients Virus Free at Six Months

6 March 2014

The Manager Companies
ASX Limited
20 Bridge Street
Sydney NSW 2000

• Study evaluated BIT225 in patients co-infected with HIV and HCV
• All HCV genotype 3 patients completing treatment are virus-free at 24 weeks
• Preliminary data from subset of patients shows benefit extends out to 48 weeks

Sydney, Australia, 6 March 2014 – Australian drug development company Biotron Limited
(ASX:BIT) today announced additional interim positive data from a key phase 2 trial of its lead
antiviral drug, BIT225, in patients co-infected with HIV and Hepatitis C virus (HCV).

Analysis of blood samples from patients indicated that all of the HCV genotype 3 patients completing treatment are virus free at the 24 week (6 month) time point. This extends previous data
that showed patients had undetectable virus levels at 12 weeks.

Response to treatment at this time point is generally a good indication of final outcome at 48 weeks. Preliminary data from patients who have completed 48 weeks of treatment indicate that they remain virus free at this key time point.

Under the protocol of this open label pilot study, 12 patients received IFN/RBV for 7 days before
commencing treatment with BIT225. They then received 300 mg BIT225 twice daily plus IFN/RBV
for 28 days. After that time, patients continued to take IFN/RBV for 48 weeks.

Biotron Managing Director Dr Michelle Miller commented; "This 24 week data further validates the
efficacy of BIT225 as a potential new therapy for HCV and, in particular, for this difficult to treat
group of HIV/HCV co-infected patients who typically have more serious HCV infection and lower
response rates to treatment with existing standard therapies."

In vitro assays have shown that BIT225 has pan-genotypic activity. Previous clinical trials of
BIT225 have focused on patients infected with the genotype 1 variant of the virus, which is the most
common genotype in Western populations. This data further extends the Company's clinical data
portfolio to include genotype 3, which is endemic in south-east Asia.

In HCV, BIT225 targets the p7 protein which is responsible for virus assembly. BIT225 also
impacts on the assembly of the HIV virus and specifically targets the virus in reservoir cells. No
existing therapy works in this way.

Dr Miller further commented; "Both the HIV and HCV viruses present substantial challenges and there is global demand for novel therapeutics. We look forward to progressing commercialisation of this important compound as a valuable new therapy that is synergistic with current and future treatment strategies."

Enquiries

Dr Michelle Miller
Managing Director
Biotron Limited
+61-2 9805 0488 +61-(0)412313329

Rudi Michelson
Monsoon Communications 
+61-3 9620 3333

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Biotron Limited: Study extends use of Hepatitis C virus treatment across more genotypes

Wednesday, November 27, 2013 by Proactive Investors

An independent study has found that Biotron's BIT225 drug candidate is effective against more genotypes of the Hepatitis C virus than previously demonstrated.

Biotron Limited's (ASX: BIT) shares are set to trade higher after receiving independent evidence that its BIT225 drug candidate for the treatment of the Hepatitis C virus is effective against more genotypes than previously demonstrated.

A new scientific paper published in the peer-reviewed journal Antiviral Research demonstrated that BIT225 is active against HCV genotypes 1, 2, 4, 5 and 6 using an in vitro cell culture assay.

This adds to the company’s studies, which demonstrated that it is active against genotypes 1 and 3, and indicates that its compound has pan-genotype activity.

Biotron’s BIT225 compound is the first in a new class of direct acting antiviral drugs for Hepatitis C. It specifically targets the p7 protein, which is involved in virus assembly.

It has recently received ethics approval to conduct a three month Phase 2 dosing study of its BIT225 drug candidate for the treatment of the Hepatitis C virus in Thailand.

The Hepatitis C global market is currently estimated at US$3.3 billion, but is expected to expand to over US$15 billion as safe, effective therapies enter the market.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Biotron Limited receives green light for Hepatitis C virus treatment dosing study

Thursday, November 21, 2013 by Proactive Investors

Biotron Limited will conduct a three month Phase 2 dosing study of its BIT225 drug candidate for the treatment of the Hepatitis C virus.

Biotron Limited (ASX: BIT) has received ethics approval to conduct a three month Phase 2 dosing study of its BIT225 drug candidate for the treatment of the Hepatitis C virus.

The study will be conducted on 60 patients at up to six trial sites in Thailand with the primary site - Bangkok’s Siriraj Hospital – granting the ethics approval.

Initial patients are expected to commence dosing by the end of this month and the trial is expected to be fully recruited by mid 2014.

Preliminary data is expected to be released by November 2014.

The study is designed to generate safety and efficacy data of BIT225 when administered over a three month period in patients infected with Hepatitis C genotypes 1 or 3.

It will use the new capsule formulation of BIT225 that is expected to have an improved safety profile and ease of use compared to the previous powder formulation.

Biotron’s BIT225 compound is the first in a new class of direct acting antiviral drugs for Hepatitis C. It specifically targets the p7 protein, which is involved in virus assembly.

The previous BIT225 study in HCV patients focused on a four week dosing regimen. Phase 2a data demonstrated that 100% of trial subjects who received BIT225 (400mg) over four weeks had undetectable levels of virus in the blood at the 48 week follow up. This was compared to 75% of patients who received standard of care alone.

The Hepatitis C global market is currently estimated at US$3.3 billion, but is expected to expand to over US$15 billion as safe, effective therapies enter the market.

Proactive Investors Australia is the market leader in producing news, articles and research reports on ASX “Small and Mid-cap” stocks with distribution in Australia, UK, North America and Hong Kong / China.

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Biotron's drug enhances antiviral activity in HIV/HCV infected patients

Friday, October 25, 2013 by Proactive Investors

Biotron's preliminary data from a Phase 2 pilot study of patients co-infected with Hepatitis C and HIV demonstrates that 100% of Genotype 3 patients completing 28 days of treatment with BIT225 in, combination with interferon and ribavirin, had undetectable Hepatitis C levels.

Biotron (ASX:BIT) will trade higher after preliminary data from a study of patients co-infected with Hepatitis C and HIV demonstrates that 100% of Genotype 3 patients completing 28 days of treatment with BIT225 in, combination with interferon and ribavirin, had undetectable Hepatitis C levels.

Patients received interferon (IFN) and ribavirin (RBV) for 7 days prior to receiving 300 mg of BIT225 twice daily plus IFN/RBV for 28 days. After that time, patients continued to take IFN/RBV for a total of 48 weeks.

All patients had undetectable levels of HIV at time of enrolment and continued to take anti-retroviral drugs throughout the study, conducted at Siriraj Hospital in Bangkok.

Interim analysis of virus levels in the treated patients indicates that all six Hepatitic C virus (HCV) Genotype 3 subjects who completed 28 days of BIT225 therapy had undetectable levels of HCV 12 weeks into the study.

Notably, response to treatment at this time point is generally a good indication of final outcome at 48 weeks.

Other new classes of direct-acting antiviral drugs in development have response rates as low as 37% after 12 weeks of treatment. In contrast, the company saw a 100% response at 12 weeks, with only 4 weeks of treatment with BIT225.

The current approved treatment for HIV/HCV co-infected patients is IFN/RBV, however up to 50% of patients are unresponsive.

Biotron’s BIT225 targets the HCV viral protein p7, which has crucial roles in virus replication and reproduction. It is a new target, and BIT225 is a first-in-class direct acting antiviral for the treatment of HCV.

A growing data set is underscoring the significance of Biotron’s new generation anti-viral drug portfolio, and BIT225 is also in development for treatment of HIV, with demonstrated clinical efficacy against HIV in reservoir cells.

Biotron's new capsule formula enhances antiviral delivery by 160%

Wednesday, August 14, 2013

Biotron (ASX:BIT) has completed a Phase 1 study using a new capsule formulation to deliver its lead HCV and HIV drug BIT225, with blood levels of the drug 160% higher than the previous powder formulation.

BIT225 is a novel compound which has recorded positive data in separate Phase 2 trials targeting the hepatitis C virus and HIV.

The new capsule is associated with reproducible absorption, and allows a lower dosage to be administered whilst achieving a higher concentration of the compound in the bloodstream.

The recent Phase 2a HIV study demonstrated that BIT225 is able to target the HIV virus 'hiding' in reservoir cells, which is regarded the 'holy grail' of current HIV research. No existing therapy is known to work in this manner.

The new capsule formulation has the potential to further enhance the already positive safety profile of BIT225, and the results will facilitate extended trials in larger patient populations.
The new BIT225 capsules are to be used in a three month Phase 2b trial of the drug on Hepatitis C patients later this year.

Today's results are value accretive, while positive results from the trial, particularly if the enhanced bio-availabilty is replicated seamlessly, will be a significant milestone for the company.

Source

Biotron Limited to report new clinical data from BIT225 Hepatitis C Phase 2a trial in a late-breaking presentation at the AASLD 2012 annual conference

- 100% of HCV trial patients receiving 400mg of BIT225 daily for 1 month, had undetectable virus at the 48 week time point

Sydney, NSW, Australia, October 16, 2012 - Biotron Limited ('Biotron'), a clinical-stage drug development company focused on development of new generation antiviral drugs, today announced that the Company will report new clinical data from its Phase 2a trial of BIT225
in patients infected with Hepatitis C virus (HCV). The data will be detailed in a late-breaking
presentation at the American Association for the Study of Liver Diseases (AASLD) 2012
annual conference in Boston, USA.

Previously released data from the 28 day Phase 2a trial of BIT225 demonstrated that BIT225
significantly increased the response to the current approved anti-HCV treatment, with improved outcomes for those patients infected with HCV. At the three-month time point 87% of patients who received BIT225 in addition to standard of care (SOC), interferon alfa-2b plus ribavirin (IFN/RBV), were clear of virus, compared to 63% of those receiving IFN/RBV alone.

The abstract titled “High sustained viral response with a HCV p7 inhibitor, BIT225: Antiviral
activity and tolerability of BIT225 plus pegylated interferon alfa 2b and weight-based ribavirin for 28 days in HCV treatment-naïve patients" will be presented in a late-breaking presentation on November 12 at The Liver Meeting® 2012, the 63rd annual meeting of the AASLD, which will take place from November 9-13 in Boston, Massachusetts.

Key new data that will be presented include results from the week 48 follow-up of trial participants. These latest results demonstrate that 100% of patients who received 400mg dose of BIT225 in addition to IFN/RBV maintained a sustained virological response (SVR), with virus levels below the limit of detection. Patients who received 200mg of BIT225 in addition to IFN/RBV had 87.5% SVR, while patients who only received treatment with IFN/RBV had 75% SVR.

The 48-week data extends the previous three-month data, and demonstrates that BIT225
appeared to continue to provide additional benefit to patients after the conclusion of dosing.
Biotron’s BIT225 targets the HCV viral protein p7, which has crucial roles in virus replication and reproduction. It is a new target, and BIT225 is a first-in-class direct acting antiviral for the treatment of HCV.

As well as being synergistic with current approved SOC HCV treatments, preclinical studies
have demonstrated that BIT225 also works well in vitro with some polymerase inhibitors, another new drug class in clinical development.

BIT225 is also in development for treatment of HIV, with a Phase 1b/2a trial currently in progress. BIT225 offers a unique opportunity for potential use in the HIV/HCV co-infected
population. A trial in this patient population is anticipated to commence before the end of
2012.

Source

Strong results from Biotron HCV trial

Nearly 90% of patients treated with Biotron's (ASX:BIT) Hepatitis C treatment candidate demonstrated a complete EVR at three month follow-up.

Dylan Bushell-Embling (Australian Life Scientist) 08 December, 2011 10:41

Sydney-based Biotron (ASX:BIT) has presented encouraging results from a trial of the use of its prospective Hepatitis C treatment, when coupled with existing therapies.

Patients treated in a phase IIa trial of Biotron's BIT225 drug candidate, combined with approved standard of care (SOC) treatments, mostly demonstrated improvement at three month follow-up.

Of the subjects to have been treated with BIT225, 87% showed a complete early viral response (EVR) – defined as virus levels in the blood below the level of detection.

This compares to 63% who received only SOC treatments interferon alfa-2b plus ribavirin, and backs up data from the four week point of the study showing significantly reduced levels of HCV virus in BIT225-treated patients.

The extent of virus reduction was dose-dependent, with the higher dose having the most effect.

Patients involved in the trial received either 200mg or 400mg doses of BIT225 for 28 days, and then remained on the SOC treatments for another 44 weeks.

Biotron CEO Dr Michelle Miller said the results of the trial were “extremely encouraging.” She said they also show that BIT225 was generally well-tolerated in patients, with the most common potential side effect being nausea, which may be solved by tweaks to the formulation.

Biotron is also in the middle of a phase 1b/IIa trial for BIT225 as a treatment for HIV.

Biotron (ASX:BIT) shares climbed 18.18% to a seven-month high of $0.130 after the results were released on Wednesday.

Source

Biotron Completes First Part of Phase 2 Trial

Drug Discovery & Development - March 10, 2011

Australian drug development company Biotron Limited has completed stage one of a landmark human trial of its lead Hepatitis C drug candidate, BIT225.

Twelve patients have been dosed in the first half of the trial being undertaken by ACLIRES, an international contract research organisation (CRO) that specialises in running antiviral drug clinical trials. All are infected with the most common strain of the Hepatitis C virus, genotype 1.

The second half of the trial - which also involves 12 patients - is now underway and expected to be completed in May, with results anticipated to be analysed and released in June. The trial is blinded, so no results are available until samples are analysed at the conclusion of the trial and the data is unblinded.

Biotron CEO, Dr Michelle Miller, said the trial was proceeding as expected and the results would be "of international interest".

She said BIT225 was a first-in-class drug candidate which specifically targeted the p7 protein, a viral protein essential to virus production and replication.

"We are happy with how the trial is progressing. We achieved the necessary ethics and drug import approvals to move to the second stage of the trial, which is now underway."

Twelve further patients are now being recruited and dosed over four weeks with BIT225.

As in stage one of the study, one-third of patients are being given a placebo, one-third a dose of 400mg BIT225 and another one -third are being dosed at 200mg BIT225.

This Phase 2 trial is examining how BIT225 works in combination with current approved treatments for HCV, Interferon and Ribavarin.

Existing drugs have limited effectiveness and can be toxic. Doctors say fifty per cent of sufferers do not respond to current therapies, signalling a need for new treatments that directly target and halt replication and reproduction of the virus.

Date: March 9, 2011

Source: Biotron Limited www.biotron.com.au/

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