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SPONSORED BY EDISON: Preparing for Dermira's Olumacostat Glasaretil Phase 3 data in AcneTicker(s): DERM, BPMX, AGN
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.
This expert call is sponsored by Edison, a global advisory and independent research company. Edison's world renowned equity research platform provides deep multi-sector knowledge and an extensive network of investors, advisors and companies providing clients with a differentiated approach to advisory services. This enables Edison to truly understand its clients’ businesses and their needs and to engage more fully with stakeholders on their behalf and in a more targeted way.
CALL LEADER: Maxim Jacobs, Director of Healthcare Research, North America
Maxim joined Edison in 2015 from Guidepoint Global, where he was a Director of Survey and Tracker Research, conducting extensive primary research across healthcare markets. He also brings more than 15 years’ experience in equities to the healthcare team previously holding positions at Ridgemark Capital, Broadfin Capital, and Mehta Partners.
Please describe your clinical practice and background treating patients with Acne.Added By: joe_mccann
Why have there been so many acne trial failures?Added By: joe_mccann
What do you consider a clinically significant benefit in acne?Added By: joe_mccann
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
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?
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?
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
If Phase 3 data meets on both primary endpoints and gets FDA nod, how do you view commercial potential?Added By: micheal015
For which patients or conditions might payers cover this drug instead of generic acne medication alternatives?Added By: user4961e1fd
did anyone benefit from this? any clues if DERM will succeed?Added By: user1625010a
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