Physician Views snap poll: Asking cardiologists to assess The Medicine Company's new data for inclisiran

Phase III data for The Medicines Company's inclisiran - presented this past weekend at the European Society of Cardiology (ESC) congress - has answered two key questions about the small interfering RNA (siRNA) therapy for atherosclerotic cardiovascular disease: it appears to be both efficacious and safe.

To read our interview with Kausik Ray – professor in the Department of Public Health and Primary Care at Imperial College London and honorary consultant cardiologist at the Imperial College NHS Trust - who presented the data for inclisiran at ESC, click here.

If approved, it remains to be seen how inclisiran will compete in the market and fare against antibody therapies that also target PCSK9 as a means to lower LDL-cholesterol. The Medicine Company's CEO Mark Timney has conceded that price could play an important role.

Dosed just twice yearly, the clinical argument in favour of inclisiran is that improved treatment compliance will translate to superior real-world efficacy.

In the meantime, we are snap-polling cardiologists (based in the US, France, Germany and the UK) to assess their evaluation of new data for inclisiran and how it may influence their future use of the product…

_____________

Q. Do you routinely treat/manage atherosclerotic cardiovascular disease (ASCVD)?

Yes

No

_____________

Q. Inclisiran is an investigational twice-yearly therapy to reduce low-density lipoprotein cholesterol (LDL-C) and the first and only cholesterol-lowering therapy in the siRNA (small-interfering RNA or "sir-nah") class.

In the Phase III ORION-11 study, inclisiran met its primary endpoint by demonstrating placebo-adjusted LDL-C reductions of 54% (p<0.0001) at day 510 and demonstrated time-averaged placebo-adjusted LDL-C reductions of 50% (p<0.0001) from days 90 through 540.

The overall adverse-event profiles of the placebo- and inclisiran-treated groups in ORION-11 were similar. A similar proportion of patients in the placebo- and inclisiran-treated groups experienced at least one serious treatment-emergent adverse event (22.5% vs. 22.3%). The incidence of deaths (1.9% vs. 1.7%) and malignancies (2.5% vs. 2.0%) was similar between the placebo and inclisiran groups. A difference between placebo and inclisiran was observed in the incidence of fatal and non-fatal myocardial infarctions (2.7% vs. 1.2%) and fatal and non-fatal strokes (1.0% vs. 0.2%).

Clinically relevant elevations in liver function tests (ALT 0.5% vs. 0.5%, AST 0.5% vs. 0.2%) and serum creatinine increases (1.4% vs. 0.6%) were similar between the placebo and inclisiran groups. The incidence of clinically relevant injection site reactions between the placebo and inclisiran groups was infrequent (0.5% vs. 4.7%), with events predominantly mild and transient.

How would you rate the clinical innovation of this product versus current standard-of-care therapy(s)?

1 - None

2

3

4 - Moderate

5

6

7 - Very high

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Q. How would you rate this product as meeting an unmet clinical need?

1 - None

2

3

4 - Moderate

5

6

7 - Very high

_____________

Q. How would you rate your likelihood of using this product if approved on the strength of available clinical data?

1 - None

2

3

4 - Moderate

5

6

7 - Very high

_____________

Q. Assuming real-world use confirms the clinical profile of this drug (as per its clinical study data), how frequently would you expect to use it versus current standard-of-care therapy(s)?

1 - None

2

3

4 - Moderately

5

6

7 - Very frequently

_____________

Results and related analysis will shortly be published for FirstWord Pharma PLUS subscribers to read, with the opportunity for non-FirstWord Pharma PLUS subscribers to purchase these findings. To be notified when poll results and analysis become available, please click here.

As always, FirstWord would very much like to receive your feedback and suggestions.

Note: FirstWord Physician Views are a fast-turnaround service to conduct instant polls of up to five questions with guaranteed samples that include physicians from dozens of specialties in major markets. To conduct this poll with a different audience, or an entirely different poll, contact us at info@firstwordpharma.com.

Disclaimer: FirstWord follows market research best practices in conducting its Physician Views polls.  However, Physician Views results should be considered directional and clients should use their market research resources for statistical analysis and conclusions required with very high confidence levels.

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