BIOTRON LIMITED (ASX:BIT) Biotech Showcase Room Mission II Tuesday, 14 Jan 2014
Forward Looking Statements This presentation may contain forward‐looking statements with respect to the financial condition, results and business achievements/performance of Biotron Limited and certain of the plans and objectives of its management. These statements are statements that are not historical facts. Words such as “should”, “expects”, “anticipates”, “estimates”, “believes” or similar expressions, as they relate to Biotron Limited, are intended to identify forward‐looking statements. By their nature, forward‐looking statements involve risk and uncertainty because they reflect Biotron’s current expectations and assumptions as to future events and circumstances that may not prove accurate. There is no guarantee that the expected events, trends or results will actually occur. Any changes in such assumptions or expectations could cause actual results to differ materially from current expectations.
Biotron Limited Overview • Clinical stage antiviral drug development company • Clinical programs for Hepatitis C virus (HCV) and HIV • Earlier stage programs include Dengue and others • Headquartered in Sydney, Australia • IPO Jan 2001 (ASX:BIT) • Key recent highlights • Nov 2013 – Commenced Phase 2, HCV gen 1 & 3, 3-month dosing trial • Oct 2013 – HIV/HCV: Announced positive preliminary HCV gen 3 data from Phase 2 trial • June 2013 – HIV: Announced positive results from Phase 2a trial • Nov 2012 – HCV: Announced positive 48-week follow-up data from Phase 2a trial
Biotron - Advanced Pipeline of Clinical Programs VIRAL INDICATION DISCOVERY PRECLINICAL PHASE 1a PHASE 1b PHASE 2a PHASE 2b STATUS TARGET • Ph 2a complete; Hep C p7 • Ph 2b (3 mth dosing) in progress HIV Vpu • Ph 2a complete • Ph 2 completed HIV/Hep C Vpu/p7 clinical phase Next • Ready for IND- generation - p7 enabling (formal preclinical) studies HCV Dengue M
Hepatitis C Virus – The Silent Killer • 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 • Standard of care is pegylated interferon and ribavirin (PEG/RBV) • Up to 50% patients don’t respond to PEG/RBV • Significant side effect profile – high drop out rate • Documented need for new, safer, direct-acting antiviral (DAA) drugs • HCV therapeutic space has seen rapid progress over last +2 years
Hepatitis C Virus – Recent Advancements • Industry focus on developing direct-acting antiviral (DAA) treatments that are: • Safe (no PEG/RBV) • Highly effective against all genotypes • Convenient (i.e. oral) • Shorter treatment duration (ideally 4 – 6 weeks) • Cost effective • Treatment of HCV requires more than one different classes of drugs to prevent resistance • Sofosbuvir (SOF)/Sovaldi (Gilead) and Simeprevir/Olysio (Janssen) received FDA approval in late 2013 • Several other polymerase and protease inhibitors, singly and in combination, also in development
Hepatitis C Virus – Recent Advancements • BUT these new treatments don’t cover everything on the wish -list i.e. • Not equally effective against ALL genotypes • Still require RBV for maximal effect • 12 weeks minimum treatment (24 weeks for gen 3) • High cost (SOF expected to cost $84,000 for 12 weeks course) • There is still a need for additional drugs for new combinations: • To target all genotypes • To remove RBV • To shorten treatment period • Reduce costs • We’re at the start of the new world of DAAs, not the end • Likely to be multiple treatment regimens to cover spectrum of HCV disease
Hepatitis C Virus – Market Opportunity Points to note: - USA and Europe represent major markets but other, larger markets are emerging. - IFN/RBV likely to remain central to treatment in these other countries due to costs - Add-ons to IFN/RBV in these countries may shorten treatment times and improve outcomes Upper-middle Source: Evolving epidemiology of hepatitis C virus (Clin Microbiol Infect. 2011; 17(2): 107-115). Income classification from The World Bank, 2013.
BIT225 – New Class of HCV DAA Drug Novel, oral, small molecule compound ENTRY INHIBITORS Only one of its class (p7 inhibitor) in clinical trials POLYMERASE/PROTEASE Inhibits viral assembly; active at later stage of virus INHIBITORS e.g. Sofosbuvir/Simeprevir life cycle to polymerase and protease inhibitors Doesn’t readily generate resistance BIT225 - ASSEMBLY/BUDDING Pan-genotype activity: INHIBITOR Clinically active against hard-to-treat HCV genotype 1 (1a and 1b) and genotype 3 Active in vitro against other main genotypes Also active against HIV hiding in reservoir cells
BIT225 – Proven Clinical Activity Against HCV BIT225 BIT225-005 Interferon + Ribavirin Placebo 0 4 wks 12 wks 48 wks 12 WEEKS 48 WEEKS Treatment Early Virological Response* Sustained Virological Response* 400 mg BIT225 + IFN/RBV 86% 100% 200 mg BIT225 + IFN/RBV 88% 88% Placebo + IFN/RBV 63% 75% *virus levels below limit of detection i.e. 50 IU/ml Clear demonstration that BIT225 has good antiviral activity in hard-to-treat, treatment-naïve HCV genotype 1 (a and b) patients
HCV Phase 2 Three-Month Dosing Trial BIT225-008 BIT225 Interferon + Ribavirin Placebo 0 4 wks 12 wks 24 wks 48 wks (end for Gen 3) (end for Gen 1) - Randomised, placebo-controlled, double-blind trial - Treatment naïve, HCV gen 1 and 3 - 3 months dosing with BIT225 in combination with IFN/RBV - Using new capsule formulation - In progress; expect to complete recruitment mid-2014 AIMS: - Demonstrate safety of BIT225 with 3 months dosing - Extend efficacy data to HCV gen 3 - Set BIT225 up for partnering with other DAA classes
HIV/HCV Co-infected Population • One third of HIV-positives are also 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 and Simeprevir) in these patients • Limited classes of new DAAs to combine with SOF in this population
BIT225 – HIV / HCV Co-Infected Trial (BIT225-006) ART Interferon + Ribavirin BIT225 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 combination with IFN/RBV – Treatment-naïve to HCV treatment with RBV and/or IFN; HIV controlled by antiretroviral drugs (ART) – Interim 12-week gen 3 data presented at AASLD conference in Washington DC in Oct ‘13
BIT225 – HIV / HCV gen 3 - Proven Efficacy • At 12 weeks - All HCV genotype 3 HCV RNA Change from baseline - G3 patients who completed treatment HCV RNA (Baseline adjusted log10 1 were clear of virus BIT225 603 - GT3a 0 602 - GT3a • Rate of decline in virus levels increased 606 - GT3a -1 after addition of BIT225 at day 7 change) 607 - GT3a -2 609 - GT3a • Data demonstrates that: 610 - GT3a -3 611 - GT3a • BIT225 is active in gen 3 -4 612 - GT3- -5 • BIT225 improves outcome for hard- LLQ -6 to-treat HIV/HCV co-infected 0 7 14 21 28 35 42 49 56 63 70 77 84 patients Time of Sample (Day) BIT225 is uniquely placed due to dual anti-HIV and anti – HCV activity
HIV – Towards a Cure • 34 million people worldwide living with HIV • Market (US and Europe) is currently US$13.36 billion p.a. • Market expected to expand to US$20 billion by 2016 • New drugs have improved the quality of life for HIV patients and prevented the virus from developing into AIDS. • Once on treatment, patients need to keep on taking the drugs to keep virus levels under control • Industry is now focused on developing drugs to eradicate or cure HIV infection
BIT225 and HIV • BIT225 has potent anti-HIV activity – Targets Vpu protein of HIV * • Similar class of protein to HCV p7 – Unique mode of action targets HIV “hiding” in long -lived macrophage reservoir cells +BIT225 • Reservoirs are last of the holy grail in HIV • No existing drugs target this source of HIV in the * body • HIV eradication necessary to minimise long-term effects of HIV infection, including HIV-Associated Neurocognitive Disorders and immune aging Control
BIT225 – Proven Clinical Activity Against HIV 16 Placebo • Phase 1b/2a randomised, placebo controlled, double-blind trial HIV-1 Replication (pg/200uL) BIT225 14 – 24 patients, HIV-1 positive, treatment-naïve 12 – 10 days dosing with BIT225 (monotherapy) 10 8 • Results demonstrated that: 6 1. BIT225 significantly reduces HIV levels in the macrophage 4 (reservoir) cells in HIV-infected subjects 2 2. BIT225 can cross the blood-brain barrier, opening up the 5 10 15 20 25 possibility of treatment of AIDS-related dementia Time in Co-culture (days) Results support a potential role for BIT225 in cure/eradication strategies
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