Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (November 2012)
25 slides from Biotron's shareholder meeting presentation, Nov 28, 2012
Slide 1: AGM November 2012
Biotrtron AGM 28 November 2012 ASX: BIT
Slide 2: Milestones Achieved in 2011/2012
Milestones Achieved in 2011/2012 • Clinical Programs: • HCV – Completed Phase 2a trial; positive data recorded • HIV - Phase 2a trial commenced end 2011; data expected 1Q2013 • HIV/HCV co-infected - Phase 2 trial commenced Oct 2012 • Non-Clinical Programs: • Progressed development of next-generation
Slide 3: Milestones Achieved in 2011/2012
Milestones Achieved in 2011/2012 • Value-adding, supporting R&D activities: • Manufactured 10kg GMP BIT225 • Developed a capsule formulation for future trials • Commenced three-month toxicology/safety studies • Other: • Strengthened Biotron’s team – new staff and directors • Strong financial positio
Slide 4: Global Perspective
GLOBAL PERSPECTIVE BIT225 has demonstrated clinical efficacy against HCV • What does this mean? • Where does BIT225 fit with other HCV programs? • Where to next?
Slide 5: HCV - Background
HCV - Background • 180 m people infected worldwide (3% world population); 130 m are chronically infected; 4 m patients in US (2.7 m chronically infected) • Majority of infected patients remain untreated or untreatable • Reportedly only 2.6% are treated each year • Up to 50% patients don’t respond to
Slide 6: HCV – Complexity of Disease
HCV – Complexity of Disease Stable chronic vs rapid progression Spontaneous clearing of virus GENOTYPES HCV Liver failure/ liver HETEROGENEITY cancer/ death CO-INFECTIONS E.G. HIV and HEP B Viral rebound following Null-responders treatment to treatment
Slide 7: Direct Acting Antivirals – What's the Story?
Direct Acting Antivirals – What’s the Story? • Industry focus is on developing new direct-acting antivirals (DAAs) • Future treatments expected to be cocktails of different classes of DAAs • Remember HIV (multi-drug resistance; evolution of treatment options) • Likely to be more than one cocktail to
Slide 8: Direct Acting Antivirals – Race isn't over
Direct Acting Antivirals – Race isn’t over *BIT225 NS5B** NS5A NS4B Entry NS3 p7 (polymerase) Inhibitors (protease) Phase 1 5 6 1 1 1 0 Phase 2 11 0 0 0 8 1* Phase 3 1 1 0 0 3 0 Phase 4 0 0 0 0 2 0 (approved) Source – clinicaltrials.gov (Nov 2012) **Over 12 NS5B drugs have failed or been withdrawn s
Slide 9: Future for HCV Treatment
Future for HCV Treatment • In the absence of a crystal ball, but based on latest data and key opinions at AASLD: • Likely to have a NS5B polymerase and a NS3 protease at its core • Likely to include ribavirin • At least one, and most likely two, other classes of drugs • Ideally, one of these will be
Slide 10: Factors Affecting Treatment Options
Factors Affecting Treatment Options Complex disease which will require a range of treatment options, including different combinations of DAAs • What will determine treatment selection? • Price • Side-effect profile • Interaction with other drugs • Disease status • Efficacy (genotype, responder statu
Slide 11: Where are the Treatment Gaps?
Where are the Treatment Gaps? • Despite recent encouraging data from various trials, significant gaps remain • Hard-to-treat groups include: • Genotype 1a • Null-responders • Partial responders • HCV/HIV co-infected population
Slide 12: Biotron's Antiviral Program Update
BIOTRON’S ANTIVIRAL PROGRAM UPDATE
Slide 13: BIT225 and HCV
BIT225 and HCV Only one of its class (p7 inhibitor) in clinical trials Works at later stage of virus life cycle to other classes of drugs Doesn’t readily generate resistance Synergistic with HCV polymerase inhibitors in laboratory studies Active against hard-to-treat genotype 1a Potentia
Slide 14: HCV Phase 2 Trial Design & Results
HCV Phase 2 Trial Design & Results BIT225 Interferon + Ribavirin Placebo 0 4 12 48 72 weeks End of EVR SVR Follow up Treatment 12 WEEKS 48 WEEKS Treatment Early Response* Sustained Response* 400 mg BIT225 + SOC 86% 100% 200 mg BIT225 + SOC 88% 88% Placebo + SOC 63% 75% *virus levels below limit of d
Slide 15: HCV Phase 2 Trial Results
HCV Phase 2 Trial Results • Clear demonstration that this first in class, direct-acting antiviral drug has good antiviral activity in treatment-naïve genotype 1 patients • Includes difficult to treat genotype 1a • Well tolerated at the doses selected in trial • Confirmed preclinical findings that BI
Slide 16: BIT225 and HIV
BIT225 and HIV • Current international focus on strategies for elimination or cure of HIV BIT225 Prevents production of infectious virus in reservoir cells Potential to eliminate this long-lived source of virus in the body • Commenced a Phase 1b/2a trial in HIV-positive patients in September 2011 •
Slide 17: HCV/HIV Co-Infected Background
HCV/HIV Co-Infected Background :• 20 – 40% HIV-infected patients are also infected with HCV in the US • Significantly worse prognosis than mono-infected • Faster HCV disease progression *BIT225 • Trials in progress: NS5B NS5A NS3 p7 (polymerase) (protease) Phase 1 0 0 0 0 Phase 2 0 0 0 1* Phase 3 0
Slide 18: HCV/HIV Phase 2 Trial Design
HCV/HIV Phase 2 Trial Design BIT225 300mg Interferon + Ribavirin ART 0 1 5 12 48 60 72 weeks End of EVR SVR SVR12 Follow up Treatment • 12 patients • HIV+, on antiretroviral treatment (ART) with stable disease • HCV+, treatment-naïve • Genotypes 1, 2 and 3 • Commenced October 2012 • Expected to run
Slide 19: BIT225 - Supporting Activities Update
BIT225 - Supporting Activities Update • Completed manufacture of 10 kg of GMP BIT225 • Demonstrated robustness and reproducibility of manufacturing process • Sufficient for current and anticipated near-future clinical trials • Completed development of an improved, capsule formulation of BIT225 • Imp
Slide 20: BIT314 – Next Generation for HCV
BIT314 – Next Generation for HCV • Designed as a follow-on from BIT225 • Increased potency against p7 • Favourable safety and druggable characteristics in preclinical testing to date • Undergoing extensive pharmacological analyses • Anticipate moving BIT314 to manufacture and formal preclinical tox/
Slide 21: Strategic Direction for Biotron's Antiviral Program
STRATEGIC DIRECTION FOR BIOTRON’S ANTIVIRAL PROGRAM
Slide 22: BIT225 – Potential Future
BIT225 – Potential Future • Hepatitis C • Part of combination cocktail with polymerase and protease inhibitors • Unique mode of action • Good drug-drug interaction profile • Limited alternative classes for combinations • HIV • Add-on to anti-retroviral treatment to clean out underlying reservoirs •
Slide 23: BIT225 – What are the Next Steps?
BIT225 – What are the Next Steps? • Other DAA HCV trials moving to at least 3 month dosing • Need 3 month human data with BIT225 before can be considered for combination with other new DAAs • Require 3 month tox/safety studies for these longer duration human studies • Proof-of-concept in the clinic
Slide 24: Activities/Milestones for 2012/13
Activities/Milestones for 2012/13 Clinical Activities: • Complete Ph 2a HIV trial (1Q2013) • Complete Ph 2 HIV/HCV co-infected trial (1H2013) • Conduct bioequivalence study in healthy volunteers with new BIT225 capsule formulation (1H2013) • Commence three-month Phase 2b HCV trial (2H2013) Non-Clini
Slide 25: Contact: Dr Michelle Miller, Managing Director
ASX:BIT Dr Michelle Miller Managing Director +61 2 9805 0488 +61 412 313329 mmiller@biotron.com.au www.biotron.com.au