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Expert Interview

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SPONSORED BY EDISON: Preparing for Dermira's Olumacostat Glasaretil Phase 3 data in Acne

Ticker(s): DERM, BPMX, AGN

Who's the expert?

Name: Dr Nanette Silverberg - MD

Institution: Mount Sinai

  • Chief of Pediatric Dermatology for the Mount Sinai Health System & clinical professor of Dermatology and Pediatrics at the Icahn School of Medicine.
  • Treats several hundred patients per month (pediatric & adult) with acne vulgaris.
  • Author on the development of the AAD Acne Guidelines; research focuses on inflammatory skin disorders such as atopic dermatitis, vitiligo and psoriasis.

Interview Questions
Q1.

Please describe your clinical practice and background treating patients with Acne.

Added By: joe_mccann
Q2.

Why have there been so many acne trial failures?

Added By: joe_mccann
Q3.

What do you consider a clinically significant benefit in acne?

Added By: joe_mccann
Q4.

The Dermira Phase III includes adolescents, who weren’t included in the Phase II trials, how could that impact the results?

Added By: joe_mccann
Q5.

The Phase 3 trial includes "a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12" which was not a primary or secondary endpoint in the Phase 2b. Management noted in the Phase 2b trial a similar proportion of patients achieved this endpoint as the patients demonstrating IGA response rate. Do you foresee this endpoint being achievable and likely in the Phase 3?

Added By: user22438b28
Q6.

What are your thoughts around Phase 2b dosing (4% and 7.5% QD and 7.5% BID) versus Phase 3 5% BID? What are the potential impacts to efficacy and hitting the primary endpoints?

Added By: user22438b28
Q7.

Do you think the Ph.3's are adequately powered to offset what have been historically high Pbo-responses in acne trials; in the range of 35-80%?  Is there any way other than robustly powering the trials to offset this potential pbo-effect?

Added By: malthuswillwin
Q8.

If Phase 3 data meets on both primary endpoints and gets FDA nod, how do you view commercial potential? 

Added By: micheal015
Q9.

For which patients or conditions might payers cover this drug instead of generic acne medication alternatives?

Added By: user4961e1fd
Q10.

did anyone benefit from this?  any clues if DERM will succeed?

Added By: user1625010a

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