Biotron Limited · ASX:BIT
Biotron — Shareholder Meeting (November 2013)
25 slides from Biotron's shareholder meeting presentation, Nov 8, 2013
Slide 1: AGM 8 November 2013
ASX:BIT Biotrtron AGM 8 November 2013 Sia
Slide 2: Milestones 2012/13: Planned vs Achieved
Milestones 2012/13: Planned vs Achieved ACTIVITY STATUS OUTCOME Complete Ph 2a HIV trial (1Q2013) " PosiAve data reported Complete Ph 2 HIV/HCV co-‐infected trial (1H2013) " PosiAve data reported Conduct bioequivalence study in healthy volunteers with new BIT225 " PosiAve data reported capsule f
Slide 3: Global Perspectives
GLOBAL PERSPECTIVES Progress in development of new HCV drugs has been rapid over last 12 months -‐ Update of field -‐ What does that mean for Biotron’s HCV program? -‐ Update on BIT225 Programs -‐ Outlook
Slide 4: HCV - Background
HCV -‐ Background • 180 m people infected worldwide (3% world populaAon); 130 m are chronically infected • HCV is 4x more prevalent than HIV • 4 m paAents in US (2.7 m chronically infected) • 75% are undiagnosed • Baby boomers -‐ >800,000 cases undiagnosed (CDC) • 5x more likely than other adults
Slide 5: Current Treatment Options
Current Treatment OpAons • Standard of care treatment has been interferon and ribavirin (IFN/RBV) • 48 weeks of treatment • Associated with debilitaAng side effects in many paAents • High drop out rate • IneffecAve in ~50% of cases • Genotype 1 parAcularly resistant to IFN/RBV • Industry focus has bee
Slide 6: Selected Classes of HCV DAA's
Selected Classes of HCV DAA’s Entry Inhibitors Protease Inhibitors (NS3) Polymerase Inhibitors (NS5B) Assembly/budding Inhibitors e.g. BIT225 Drugs must be used in combina1on to minimise virus becoming resistant to drugs
Slide 7: Current HCV DAA Approval Landscape
Current HCV DAA Approval Landscape Protease Inhibitors -‐ First generaAon approved in 2011/12 -‐ Boceprevir and Telaprevir -‐ Second generaAon expected to be approved late 2013 -‐ Simeprevir (SIM; Janssen) -‐ Expected to replace Boceprevir and Telaprevir Polymerase Inhibitors -‐ First approval
Slide 8: Current DAA Treatment Outcomes – Gen and Selected Overview
Current DAA Treatment Outcomes – Gen 1 and 2 Selected Overview Genotype 1 -‐ Most common variant in USA, Europe and Australia -‐ New DAAs (with and without IFN+/-‐ RBV); 12 weeks therapy -‐ Overall cure rates (SVR12) -‐ Non-‐cirrhosis ~92% -‐ Cirrhosis ~80% Genotypes 2, 4, 5, 6 -‐ Respond we
Slide 9: Selected Current DAA Treatment Outcomes – Genotype 3
Selected Current DAA Treatment Outcomes – Genotype 3 Genotype 3 -‐ Higher prevalence in lower socio-‐economic groups -‐ Predominant variant in Asia -‐ Large proporAon of future cases expected to be gen 3 (intravenous drug users) -‐ Treatment with new DAA classes is more problemaAc than Gen 1 an
Slide 10: Why Additional Classes of DAAs Are Still Needed
Why AddiAonal Classes of DAAs Are SAll Needed (For All Genotypes) - SOF, SIM etc have only been assessed under trial conditions - Treatment decisions are being made on limited trial data (often Ph 2) - Real world will impact on SVR rates post-approval - Patient compliance with taking drugs for exten
Slide 11: HIV/HCV Co-Infected Population
HIV/HCV Co-‐Infected PopulaAon • One third of HIV-positives are infected with HCV • Rapid progression to liver failure • Respond poorly to IFN/RBV • ~ 19% SVR rate • Often an after-thought in trials of new DAAs • Drug-drug interactions limits use of protease inhibitors (i.e. Boceprevir, Telaprevir
Slide 12: BIT225 and HCV
BIT225 and HCV ü Novel, oral, small molecule compound ü Only one of its class (p7 inhibitor) in clinical trials ü Inhibits viral assembly; acAve at later stage of virus life cycle to polymerase and protease inhibitors ü Clinically acAve against HCV genotype 1 (1a and 1b) and genotype 3 ü Doesn’
Slide 13: BIT225 – Proven Clinical Activity Against HCV
BIT225 – Proven Clinical AcAvity Against HCV BIT225 Interferon + Ribavirin BIT225-‐005 Placebo 0 4 wks 12 wks 48 wks 48 WEEKS 12 WEEKS Treatment Sustained Virological Early Virological Response* Response* 400 mg BIT225 + 86% 100% IFN/RBV 200 mg BIT225 + 88% 88% IFN/RBV Placebo + IFN/RBV 63% 75% *vi
Slide 14: BIT225 – HIV / HCV Co-Infected Trial
BIT225 – HIV / HCV Co-‐Infected Trial BIT225-‐006 BIT225 Interferon + Ribavirin ART 0 1 wks 5 wks 48 wks • Phase 2 HIV/HCV trial -‐ completed clinical phase in July 2013 – Genotypes 1 and 3; 28 days dosing in combinaAon with IFN/RBV – Treatment-‐naïve to HCV treatment with RBV and/or IFN; HIV co
Slide 15: HCV RNA (Baseline adjusted log10 change)
BIT225 – HIV / HCV Co-‐Infected Trial (cont) HCV RNA Change from baseline -‐ G3 HCV RNA (Baseline adjusted log10 change) 1 PR BIT225 603 -‐ GT3a 0 602 -‐ GT3a -‐1 606 -‐ GT3a 607 -‐ GT3a -‐2 609 -‐ GT3a 610 -‐ GT3a -‐3 611 -‐ GT3a 612 -‐ GT3-‐ -‐4 -‐5 LLQ -‐6 0 7 14 21 28 35 42 49 5
Slide 16: BIT225 – HIV / HCV Co-Infected Trial (cont)
BIT225 – HIV / HCV Co-‐Infected Trial (cont) • Genotype 1 response was impacted by a geneAc change in IL28B in two paAents – this means that they are unable to respond to IFN/RBV • Data from previous 005 trial demonstrated that BIT225 works in gen 1’s • This trial demonstrates that: • BIT225 is acZ
Slide 17: Why Are We Using IFN/RBV in BIT225 Trials?
Why Are We Using IFN/RBV in BIT225 Trials? • Drugs to treat chronic viral diseases such as HIV and HCV can’t be used on their own • IFN/RBV has been the only approved treatment for HCV • Other new DAAs have also been trialled in combination with IFN/RBV • IFN/RBV + DAA combination data is used to de
Slide 18: Where Do These Results Position BIT225 in the New DAA World?
Where Do These Results PosiAon BIT225 in the New DAA World? -‐ BIT225 works against HCV genotypes 1 and 3 Well posiAoned for genotype 3, which has greatest unmet need -‐ All paAents finishing treatment responded with just 28 days of BIT225 -‐ PotenAal to add to new DAAs e.g. SOF + RBV to improve o
Slide 19: HIV – Towards a Cure
HIV – Towards a Cure • 34 million people worldwide living with HIV • AnA-‐HIV drugs (ART) have improved the quality of life for HIV+ * paAents • BUT – ART does not eradicate HIV infecAon • Sustained, low-‐level HIV replicaAon occurs in ART-‐treated paAents • Reservoirs of infecAon hide virus from
Slide 20: BIT225 – Proven Clinical Activity Against HIV
BIT225 – Proven Clinical AcAvity Against HIV • Phase 1b/2a randomised, placebo controlled, double-‐blind trial (BIT225-‐004) – 24 paAents, HIV-‐1 posiAve, treatment-‐naïve – 10 days dosing with BIT225 (monotherapy) • Results demonstrated that: 1. BIT225 significantly reduces HIV levels in the mac
Slide 21: BIT225 – Stepwise Progression to Commercialisation
BIT225 – Stepwise Progression to CommercialisaAon • Strategy is guided by: • Advisory panels of US-based KOLs who are leaders of the field • Interaction and feedback from US healthcare analysts who specialise in antiviral space • Interaction and feedback from potential partners • Biotron continues t
Slide 22: BIT225 - HCV Phase 2 Three-Month Dosing Trial
BIT225 -‐ HCV Phase 2 Three-‐Month Dosing Trial BIT225 Interferon + Ribavirin BIT225-‐008 Placebo 0 4 wks 12 wks 24 wks 48 wks (end for Gen 3) (end for Gen 1) -‐ Randomised, placebo-‐controlled, double-‐blind trial -‐ 3 months dosing with BIT225 in combinaAon with IFN/RBV -‐ Treatment naïve,
Slide 23: Biotron Outlook 2013/14
Biotron Outlook 2013/14 4Q13 1Q14 2Q14 3Q14 4Q14 4Q13 -‐ Commence Mid ‘14-‐ Ph2 HCV (3 month Complete HCV dosing with IFN/RBV) enrolment Preliminary, interim (BIT225-‐008) of data from Ph 2, 3 BIT225-‐008 month HCV trial (BIT225-‐008) HIV IND AddiZonal data Submit an from the Phase 2a InvesZgaZ
Slide 24: BIT225 – Multiple Market Opportunities
BIT225 –MulAple Market OpportuniAes • C HepaZZs • PotenAal for future combinaAon cocktails with polymerase and protease inhibitors • Unique mode of acAon • Good drug-‐drug interacAon profile • Limited alternaAve classes for combinaAons (prevenAon of resistance) • PotenAal to fill gaps len by other DA
Slide 25: 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