Level 2, 6 6 Hunter Str reet Sydn ney NSW 20 000 Tel: ( 61-2) 9300 33 344 Fax: ( 61-2) 9221 63 333 E-mail: pn nightingale@ @biotron.com .au W Website: www. .biotron.com .au 28 November 2 2018 Th he Manager C Companies AS SX Limited 20 Bridge Stree et SY YDNEY NSW W 2000 (3 p pages by ema ail) De ear Madam, PRESENTA P ATION OF B BIT225-009 HIV-1 PHA ASE 2 DATA A Th he Directors of Biotron L Limited (‘Bi iotron’) are pleased to a advise that th he attached poster prese entation entit tled “B BIT225-009: Significant Immunologi ical Outcome es after 12 w weeks of BI T225 and A Antiretroviral l Therapy in n an HI IV-1 Phase 2 2 Clinical Tri ial” is being presented at t the HIV DA ART and Em merging Viru uses 2018 me eeting curren ntly un derway in M Miami, Florid da. HI IV DART an nd Emerging g Viruses 20 018 is a bia annual meeti ing that aim s to bridge the gap bet ween the la test sci ientific devel lopments and d routine clin nical practice e in the conte ext of HIV in nfection and emerging vi iruses. Th he presentatio on provides scientific dat ta and analy yses relating to the BIT22 25-009 Phase e 2 HIV-1 cl linical trial. As pre eviously adv vised, the res sults indicat e that BIT22 25 is having g a unique e effect in pati tients, over a and above v viral sup ppression see en with curre ent antiretrov viral drugs. Th he data show ws that there e are signific cant immuno ological ben efits in patie ents receivin ng antiretrov viral drugs w with 20 0 mg BIT22 5 compared to antiretrov viral drugs pl lus placebo. Th hese include a statisticall ly significan nt reduction i in plasma le evels of the macrophage e immune ac tivation mar rker sol luble CD163 3 (sCD163), which is a g good indicat tor of all cau use morbidit ty and morta ality in HIV- -1 patients w with we ell-controlled d viral load. Additional reduction of f this marker r in patients taking BIT2 225 demonstr rates signific cant im mmunological l benefit, and d may open u up the possib bility of a rol le for BIT22 5 in treatmen nt of high-ri sk patients w with HI IV-1 infectio n. In addition, the e results show wed statistic ally significa ant differenc ces in the pro ofiles of two specific T-c cell populatio ons, mely CD8 + ed CD4 + T- nam and activate -cells, during g the BIT22 25 treatment t period. Th hese reflect the signific cant dif fferences in immunologi ical response es in patient nts receiving 200 mg BI IT225 with current antir retroviral dr rugs (A ART) compar red to placebo o with ART. . As s previously advised, BI IT225 work s by interfe ering with th he assembly of HIV-1 i in macropha age cells. T The out tcome is the production of replicatio on-deficient i i.e. non-infec ctious virus b by these cell ls which serv ve as long-liv ved D8 + and acti ivated CD4 + res servoirs of H HIV-1 virus in the body . The chang ges seen in levels of CD T-cells in t trial sub bjects receiv ving ART + + BIT225 tr eatment are consistent with the bo ody’s immun ne system r recognising t this rep plication-inco ompetent vir rus as a sourc ce of antigen n. This imm munological r esponse is no ot seen in tri ial subjects w who did d not take BI IT225 (i.e. to ook ART + p lacebo).
The Phase 2 trial data has indicated that BIT225 has significant and unique effects on immunologic endpoints, compared to approved antiretroviral drugs. Data is consistent with targeting and eradication of virus from macrophage reservoir cells by BIT225. The results are encouraging and could lead to a role of BIT225 as part of a cure strategy. As previously advised, Biotron will be seeking a partner to support future clinical trial evaluations to further characterise a clinical impact on viral eradication. Samples from the trial will be subject to ongoing analyses to further characterise the demonstrated effect of BIT225 in these patients. Yours sincerely Peter J. Nightingale Company Secretary pjn9730 About Biotron Biotron Limited is engaged in the research, development, and commercialisation of drugs targeting significant viral diseases with unmet medical need. The Company has BIT225 in clinical development for HIV-1, and a promising preclinical program for HBV. In addition, Biotron has several earlier stage programs designing drugs that target a class of virus protein known as viroporins which have a key role in the virus life cycle of a very broad range of viruses, many of which have caused worldwide health issues such as Dengue, Ebola, Middle East Respiratory virus, Influenza and Zika viruses. Enquiries Dr Michelle Miller Rudi Michelson Managing Director Monsoon Communications Biotron Limited +61-3 9620 3333 +61-(0)412313329 2
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