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Expert Interview

Slingshot members are talking to an expert! The topic is:

Examining the potential of Astellas’ fezolinetant as a treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Ticker(s): ALPMY

Who's the expert?

Institution: Yale University School of Medicine

  • Clinical Professor, OBGYN at Yale University;Board-certified obstetrician/gynecologist and author with an extensive background in women’s health issues.
  • Co-author of A Woman's Guide to Menopause and Perimenopause and The Yale Guide to Women's Reproductive Health as well as the author of articles in numerous peer-reviewed journals. 
  • Treats several hundred women with VVA and hot flashes (15+ patients/week with VVA and dyspareunia); regularly prescribe estradiol and micronized natural progesterone.

Interview Questions
Q1.

Roughly how many patients with VMS associated with menopause do you see monthly

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Q2.

On a scale from 1-10, 10 being extremely excited, where would you rate your level of excitement for this drug?

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Q3.

How is VMS currently managed?
How much is hormone replacement still used, and how that has evolved?
Does any over the counter stuff actually work? 
How would you characterize the unmet need?

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Q4.

Fezolinetant as a Neurokinin 3 Receptor antagonist - thoughts on Mechanism of action and its relevance in VMS ?

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Q5.

What is your take on the Phase 3 trial data-Efficacy and safety.

Long-term extension study - does this give you confidence women can be treated longterm with this drug?

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Q6.

Does the failure of the Moonlight trial in Asian countries (China, Korea, and Taiwan) surprise you?  Does it dampen your enthusiasm about the drug?
Could this possibly not work in people of Asian ethnicity? 

(The trial showed a numerical trend but not stat sig).

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Q7.

Two other similar drugs of this class that I know of, Bayer (from KaNDY therapeutics) NT-814And ACER Therapeutics, ACER-801

Are these different at all from this compound and could these also have success?

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Q8.

Potential for off label use of Fezolinetant?   Will this require patients to pay out of pocket?

ACER is developing their drug in "induced VMS" the non-menopausal indications specifically.  Will a phase 3 program specifically in those conditions be important to reach those patients?

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Q9.

Any specific types of patients you would NOT prescribe fezolinetant? 

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