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Expert Interview

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A Second View: Discussing Amgen's OCEAN(a) study and the potential of olpasiran in treating patients with elevated Lipoprotein(a) and evidence of atherosclerotic cardiovascular disease (ASCVD)

Ticker(s): AMGN

Who's the expert?

Institution: Renown Medical Center Institute for Heart and Vascular Health (Nevada)

  • Medical Director of Vascular Medicine and Anticoagulation Services at the Renown Medical Center Institute for Heart and Vascular Health; served as Vice President of the Board of the American Society of Hypertension (ASH).
  • Manages about ~40 patients with lp(a) >150 mg/dl, and <150 patients with SHTG
  • Clinical Interests include management of hypertension, dyslipidemia, anticoagulation, vascular disease, and heart disease and stroke prevention.
  • Principal investigator on numerous clinical trials, most recently focused in the field of device therapy for hypertension. Research focused on diagnosis and management of renovascular disease and exploring novel means of overcoming barriers to hypertension and dyslipidemia control.

Interview Questions
Q1.

-- Background info on your expertise and details about your clinical practice and setting?

Added By: dami_admin
Q2.

Can you speak about the importance of LP(a) and what's been established in the research on its role as a cardiovascular risk factor?

Added By: dami_admin
Q3.

How many patients do you treat that have >150 nmol/L LP(a) even with your optimal statin/pcsk9 lipid treatment strategy?

Added By: dami_admin
Q4.

Amgen says LP(a) is elevated in 20% of the US population. Do you agree with this estimate?

Added By: dami_admin
Q5.

What do you think might be LP(a) goal levels for a reduction that will confer clinical benefit?

Added By: dami_admin
Q6.

In terms of CV risk from LP(a), how do you contextualize this risk vs. that of LDL? Are they correlated at all?  Is the magnitude of each different or are they similar? 
What do you make of the fact that drugs which decreased LP(a) significantly (Niacin and estrogen) did not impact CV outcomes?

Added By: dami_admin
Q7.

There are a few conflicting studies on LP(a) risk in the context of low LDL, where in one study (AIM-HIGH), elevated LP(a) seemed associated with CV risk, but in another study (Nicholls et al) it was not.  If benefit will be confined only to elevated LP(a) in high LDL setting, will there be any opportunity for these drugs?

Added By: dami_admin
Q8.

In phase 1 single dose Olpasiran at 225 mg, which is the dose they used in phase 2, knocked down LPA by 94% at day 113. At day 155 it looks like around 80% possibly. That seemed to support quarterly dosing, and they went with every 12 week dosing in phase 2. Can you please comment on this? 

Added By: dami_admin
Q9.

Amgen recently announced phase 2 data. Namely, "a significant reduction from baseline in Lp(a) of up to or greater than 90 percent at week 36 (primary endpoint) and week 48 (end of treatment period) for the majority of doses."

What is your interpretation and how do you put this in the context of data from competitors like Pelacarsen (antisense approach)? Or Silence Therapeutics SLN360 (an siRNA)?

Added By: dami_admin
Q10.

Is the safety profile a concern for Pelacarsen given the history of antisense oligonucleotide drugs?  Is olpasiran potentially differentiated for better knockdown and safety?  

Added By: dami_admin
Q11.

How might payors treat a new expensive medication that would be given on top of LDL lowering meds?  
Is there a threshold for the magnitude of CV Risk reduction in the phase 3 CVOT trials that you want to see to use Olpasiran or similar agents?

Added By: dami_admin
Q12.

How would you design the phase 3 CVOT trial to best assess Olpasiran's utility?  

Added By: dami_admin

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