Re: Holding steady
in response to
by
posted on
Dec 22, 2018 09:37PM
"Question: will all these new phase 3 trials needed to expand ABL market,... will they all have to be as big as this current Phase3,... and take as long,...?"
Most Phase 3 CVOTs are bigger and longer (TWSS) than BETonMACE. In general, the lower the patient CVD risk, the more patient years required to achieve x number of events. And as the absolute risk drops, so does the anticipated absolute risk reduction, thus necessitating a greater number of total events in the trial. So follow up Phase 3 CVOTs for apabetalone in lower risk populations will be larger and/or longer than BETonMACE, in my opinion.
Right now, the only trials listed in the Resverlogix September AGM, November Bio-Europe and December Corporate Update are four Phase 2 trials for CKD, Fabrys disease, pulmonary arterial hypertension, and vascular cognitive dementia all with initiation listed as H2 2019. Clinicaltrials.gov lists a Phase 1 PAH, Phase 1/2 renal and Phase 1/2 Fabrys trial, but not a cognitive dementia trial. The three listed trials are small (<100 patients), short (<2 years), and not yet recruiting. A Phase 3 renal/CKD trial may need to wait until the Phase 2 is over.
Apabetalone has to start somewhere. Hopefully a BETonMACE home run.
BearDownAZ