Biotron Phase 2 Hepatitis C Trial Success

Biotron Phase 2 Hepatitis C Trial Success - HCV genotype 1 patients treated with BIT225 and Interferon/Ribavirin (IFN/RBV) significantly more likely to clear virus than those treated with IBN/RBV alone

- Major advance in capsule form of BIT225

- BIT225 safe and well tolerated

 

NEW YORK, March 17, 2016 /PRNewswire/ -- Biotron Limited (ASX: BIT) confirms positive outcomes from its Phase 2 study of its first-in-class antiviral drug BIT225.

The trial was designed to assess the safety and antiviral activity of three month's dosing of BIT225 in patients infected with Hepatitis C virus (HCV). In addition, the trial provided key information on a new capsule form of BIT225, information that is critical for determining dosage in further studies with the drug.

Key outcomes from analysis of the 30-subject HCV genotype 1 (G1) cohort:

• BIT225 was safe and well-tolerated with none of the HCV G1 patients withdrawing due to BIT225-related adverse events.
• HCV G1 patients treated with BIT225 and IFN/RBV are significantly more likely to clear virus within 24 weeks of commencing treatment than those treated with IFN/RBV alone.
• 12 weeks after stopping BIT225 treatment, 82% of HCV G1 patients treated with BIT225+IFN/RBV were clear of virus, compared to 60% of those treated with IFN/RBV alone.
• The trial has provided key data on the performance of the capsule formulation of BIT225, which is central to future studies with the drug.

Biotron's Managing Director, Dr Michelle Miller, remarked: "We are delighted with the outcome of this trial of a new class of pan-genotypic anti-HCV drug. The safety profile of BIT225 in these HCV G1 patients was excellent, and the drug had a clear beneficial antiviral effect over and above the standard of care IFN/RBV."

"The data supports a potential role for BIT225 to be used in combination with new HCV drugs that have recently entered the market to shorten patient treatment times and improve treatment outcomes. We continue to explore licensing opportunities for BIT225 and HCV."

"The safety and capsule formulation data from this trial can be used to support an upcoming Phase 2 trial in patients infected with HIV-1, against which the drug is also active. This is anticipated to start in mid-2016."

The trial was a multi-centre, placebo-controlled, randomised study of the safety, pharmacokinetics and antiviral activity of BIT225. The trial achieved its two primary endpoints evaluating safety and efficacy, as well as its secondary endpoints, including assessment of the assessing antiviral activity and pharmacokinetics of the new capsule formulation. The study was conducted at several clinical trial sites in Thailand.

Analysis of the trial data is ongoing, and the Company aims to present detailed data at a scientific conference later in 2016.

About Biotron

Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need, with a major focus on HIV and HCV. The Company has BIT225 in clinical development for both HIV and HCV, and also has several earlier stage preclinical and research programs for several other viral infections including Dengue.

Enquiries

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

Rudi Michelson
Monsoon Communications
+61-3 9620 3333

SOURCE Biotron Limited

Australian drug developer Biotron may have found a potential cure for Hepatitis C.

Australian drug developer Biotron may have found a potential cure for Hepatitis C.

Biotron on Friday said that all patients who completed a phase II clinical trial of its antiviral drug, BIT225, in combination with other drugs, had undetectable levels of Hepatitis C 12 weeks after ceasing treatment.

An undetectable level of Hepatitis C virus 12 weeks after completion of treatment is considered to be "a prediction of permanent clearance of the virus and, effectively, a cure", Biotron said.

The news pushed up Biotron shares five cents, or 50 per cent, to 15 cents.

Biotron managing director Dr Michelle Miller said data from the trial supported BIT225 as a potential new therapy for Hepatitis C, especially for patients with both HIV and Hepatitis C who typically had more serious Hepatitis C infection and fewer treatment options.

"Both HIV and HCV viruses present substantial challenges for treatment and represent multi-billion-dollar markets," Dr Miller said.

"We look forward to progressing commercialisation of BIT225 as a valuable new therapy that will work in combination with current and future treatment strategies."

Dr Miller said treatment including BIT225 could benefit patients in that it was more effective, required a shorter treatment time and was less expensive.

The phase II trial in Bangkok involved eight patients with HIV and Hepatitis C.

Biotron said although the number of patients in the trial was small, the fact that 100 per cent had no Hepatitis C virus detected from the 12th week into the trial onwards was encouraging evidence of BIT225's efficacy.

Dr Miller said the next important step in the development of BIT225 for the treatment of Hepatitis C would be the results of a larger trial involving 60 patients.

Preliminary data from the larger trial is expected before the end of 2014.

Hepatitis C is one of five viruses causing Hepatitis, which means inflammation or swelling of the liver.

A chronic Hepatitis infection can result in liver damage.

Hepatitis C is spread through blood-to-blood contact.

The eight patients starting the Bangkok trial received "standard" Hepatitis C drugs - interferon and ribavirin - for seven days before starting treatment with BIT225.

They then received BIT225 twice a day, plus the "standard" drugs for 28 days.

After that, patients continued to take the interferon and ribavirin until week 48, at which time all treatment stopped.

Three patients withdrew during the first 12 weeks of the study due to intolerance of the interferon and ribavirin treatment.

The remaining five had undetectable levels of Hepatitis C after week 12.

Virus levels continued to be undetected at week 24 and at week 48, when all treatment ceased.

At week 60 - 12 weeks after treatment finished - all the patients who completed the course remained clear of the Hepatitis C virus.

Source

AASLD - BIT225 Hepatitis C Virus 48-week data

Biotron Limited : 16/11/2012 - Presentation of BIT225 Hepatitis C Virus 48-week data at AASLD conference, Boston MA

11/18/2012| 03:13am US/Eastern        
PRESENTATION OF BIT225 HEPATITIS C VIRUS 48-WEEK DATA AT AASLD CONFERENCE, BOSTON MA
  
- 100% SVR in patients receiving 400mg BIT225 in combination with standard of care
- No detectable antiviral resistant variants generated during treatment
  
Download PDF

Sydney, Australia: 16 November, 2012: Australian drug development company Biotron Limited (ASX:BIT) has presented the latest data from its Phase 2a trial of BIT225 in patients infected with hepatitis C virus (HCV) in a presentation at the American Association for the Study of Liver Diseases (AASLD) 2012 annual conference that took place this week in Boston MA, USA.

The poster entitled "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" is attached in the Appendix that follows. It was presented in a late-breaking poster session at The Liver Meeting® 2012, the 63rd annual meeting of the AASLD.
  
The new data shows that 100% of patients who were treated with 400mg BIT225 in combination with the current approved anti-HCV treatment had no detectable virus at the 48-week time point. This compares to 75% of patients who only received the approved treatment, and demonstrates that in this trial BIT225 improved the outcome in patients infected with hard-to-treat genotype 1 HCV infection.
Analysis of blood samples taken from the patients after dosing with BIT225 indicated that the drug did not induce antiviral resistance.
  
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.
  
"The data from this trial are very encouraging - to see no detectable virus at the 48 week follow-up is a good outcome for the patients, who are infected with the hard-to-treat genotype 1 version of the virus," reported Michelle Miller, Managing Director of Biotron. "During preclinical development of BIT225, laboratory studies indicated that BIT225 could potentially improve the activity of interferon and ribavirin, and this trial has confirmed that this has translated into benefit for the patients. In addition, the drug does not appear to readily generate resistance, which can be a problem with some of the other new classes of anti-HCV drugs in development."
  
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.
  
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 phase 2 trial in this patient population is current recruiting.   
        
About Biotron
Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need, with a major focus on HIV and HCV. The Company has BIT225 in clinical development for both HIV and HCV, and also has several earlier stage preclinical and research programs for several other viral infections including Dengue.

About BIT225 and HCV
BIT225 represents a first-in-class drug for treatment of HCV, targeting the p7 protein of HCV. It is estimated that in the USA alone, some 4 million people have been infected with Hepatitis C with 2.7 million suffering from chronic infection. Worldwide, 170 million people are infected. HCV causes inflammation of the liver, which may lead to fibrosis and cirrhosis, liver cancer and, ultimately, liver failure. Existing drugs for HCV have limited effectiveness and toxicity issues, leaving a significant need for new therapies. The worldwide market is currently almost US$3.3 billion, but is estimated that this market will expand to over US$10.0 billion as safe, effective therapies enter the market.

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Hepatitis C drug candidate, BIT225 Australian Drug Co Biotron Limited

Biotron -- Stage One of Landmark Hepatitis C Drug Trial Completed

Second half of trial now underway
Results expected June 2011

Sydney, Australia, 10 March 2011: Australian drug development company Biotron Limited (ASX: BIT) 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 II 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.

About Biotron

Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need, with a major focus on HIV and HCV. The Company has BIT225 in clinical development for both HIV and HCV, and also has several earlier stage preclinical and research programs for several other viral infections including influenza, Dengue and Hepatitis B.

About BIT225 and HCV

BIT225 represents a first-in-class drug for treatment of HCV, targeting the p7 protein of HCV. It is estimated that in the USA alone, some 4 million people have been infected with Hepatitis C with 2.7 million suffering from chronic infection. Worldwide, 170 million people are infected. HCV, which causes inflammation of the liver and which may lead to fibrosis and cirrhosis, liver cancer and, ultimately, liver failure. Existing drugs for HCV have limited effectiveness and toxicity issues, leaving a significant need for new therapies. The worldwide market is currently almost US$3.0 billion, but is estimated that this market will expand to over US$10.0 billion as safe, effective therapies enter the market.

Monotherapy with Interferon and combination therapy with Interferon and the ribonucleoside analog Ribavirin are the two different regimens currently approved as therapy for chronic hepatitis C. Treatment with Interferon alone, or in combination with Ribavirin, has limited effectiveness. The use of interferon-based therapy for the treatment of HCV can be further limited by frequent side effects, injectable administration and poor patient tolerance and adherence. Many patients receiving Interferon can experience influenza-like symptoms, fatigue and depression. Ribavirin can be problematic for patients with pre-existing anemia, kidney problems or heart disease.

Preclinical studies have shown that BIT225 is highly synergistic with Interferon and Ribavirin, the current approved drugs for HCV treatment, as well as with NS5B-inhibitors which are a new class in development. The use of BIT225 in combination with either the current standard of care treatment, or NS5B inhibitors, holds exciting potential therapeutic treatment of human HCV infections.

For further information please contact Dr Michelle Miller, CEO and Managing Director on (61-2) 9805 0488.

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