DXB 1.64% 30.0¢ dimerix limited

Phase 2b Data Readout- ~12 months out !!

  1. 853 Posts.
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    If you haven't read the latest corporate presentation (22 Nov 2017) then I strongly suggest you do.. I haven't seen anyone comment on this forum on the material update in that presentation.. Let's all focus on adding value to this thread and educating new and prospective investors to the potential (and risks) of DMX-200 and DXB in general rather than squabbling over rubbish.. [and yes, with the small volumes traded in DXB at present, HC sentiment does impact the share price]

    So I'll start..

    The Company has for the first time stated that we will have a readout from the Ph2b clinical trial in 2H CY2018!! This is an excellent result; and I'm very glad management understand that they need to get data out asap and provide the market a near-term catalyst.

    This has resulted from separately reporting on FSGS (n=10) patients in the Ph2b study and Diabetic Nephropathy, DN, (n=60) in the study. The FSGS cohort will be on study for 9 months following enrolment (including run-in [3], treatment [3] and follow up [3]) whereas the DN patients will be on study for 12 months (run-in [3], treatment [6] and follow up [3]). It won't take them long at all to recruit the 10 FSGS patients so we're only about 12 months away from a significant data read-out! Remember, DMX-200 has been granted orphan designation in the US for FSGS.

    The DN data readout will be approx 6-7 months later by my estimation given the extra 3 months treatment phase and an extra 3 months to recruit the 60 patients. Could allow another month to analyse the data from the increased n=60 too. Given, the stellar results for DN patients from the Ph2a study, there will be significant patient and investigator interest to recruit quickly. I estimate 3-4 patients per site across 6 Aus sites over 3 months to complete recruitment. Investigators will be able to pre-identify patients from now, so with a little push from the Company- this recruitment timeline should be achievable.

    Let's not forget.. Ph2a data showed a 30-35% reduction in proteinuria in Diabetics over and above standard of care!! The anticipation of a similarly positive result from Ph2b (which would be worth hundreds of millions to the Company) will be huge..

    From my experience, the share price of ASX-listed biotechs tends to run up around 6 months out from a Ph2b data readout... so I'm anticipating something similar around mid next year.. with greatest anticipation for the DN data due in 2019.

    I'll update on FSGS competitors shortly...

    GLTAH

    A.
 
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