Expert Interview
A Second Look: Examining the potential of Krystal's B-VEC in treating dystrophic epidermolysis bullosa (DEB) after FDA granted Priority Review designation
Ticker(s): KRYSInstitution: Dermatology Associates of Western Connecticut
- Assistant Clinical Professor of Dermatology in the Yale University School of Medicine, dermatology specialist at private practice.
- Professional special interests include the treatment of skin cancer and pediatric dermatology.
- Treats 2-3 patients with merkel cell carcinoma annually
How many patients with Dystrophic Epidermolysis Bullosa do you manage?
Added By: dami_adminOn a scale from 1-10 (10 being extremely excited) where would you rate your level of excitement for Vyjuvek in this treatment population?
Added By: dami_adminWhat are your main takeaways from the GEM-3 Phase 3 Trial data on B-VEC (Vyjuvek)?
How important for management of these patients is the efficacy that they are demonstrating on % complete wound closure?
Your impressions of the safety profile?
Added By: dami_adminCan this therapy help prevent the development of cSCC?
Added By: dami_adminIn terms of wound size, most of the efficacy was demonstrated in wounds 20cm squared or less, around 20% of wounds chosen were 20-40 cm2, and just a couple of wounds >40cm2 (And they got complete healing in 1 out of 2 of those).
Is this distribution similar to what you see in practice? Are 75% of wounds 20cm2 or less? Or are larger wounds more common?
How confident are you about the therapy being able to treat wounds that are larger than 20cm2?
Was there any information presented about the chronicity of the wounds healed in the trial, and is this an important factor?
Added By: dami_adminDid you see any drawbacks or potential caveats with regard to the phase 3 trial data?
Added By: dami_adminMost patients in the trial developed antibodies against Col7. But at 6 months they showed no differences in efficacy among those who seroconverted vs. those who didn't, and no major difference between those with HSV-1 antibodies at baseline vs. those without.
Will the therapy stop working eventually?
Abeona has a competing gene therapy product in Phase 3 that will read out within the next few months. This is a skin graft procedure, and in early data it has shown long durability (multiple years) with efficacy on very large sized wounds.
How would you compare the two approaches and how would you decide between them?
Will patients be more likely to take a topical therapy?
Is the hospitalization for immobilization following the graft procedure a deterrent to its use?
Is continued application over the longterm with B-VEC a factor? Following achievement of wound closure, do we know how long the wounds remain closed without the need for reapplication of B-VEC or how often it needs to be reapplied?
Are there different types of wounds or locations of wounds that may be more appropriate for one therapy vs. the other?
Do you expect FDA to approve B-VEC based on the data reported?
If approved, What percentage of your DEB patients will you treat with this product?
Are You Interested In These Questions?
Slingshot Insights Explained
Expert research benefits investors by giving them timely access to unbiased real world perspectives on highly specialized topics. Slingshot Insights' crowdfunded model makes this access available at a fraction of the cost of other expert networks.
Reason
*Slingshot Insights provides access to information, not investment advice. We work to support you and facilitate access to experts; however we are not responsible for monitoring calls for the disclosure of MNPI. You should obtain financial, legal and tax advice from your qualified and licensed advisers before deciding to invest in any security.
