Neil Clark of Destiny Pharma discusses positive update from FDA on their XF-73 nasal gel

Justin Waite
Vox Markets Podcast
10:35, 19th July 2022
AudioBoom | https://audioboom.com/posts/8123368-neil-clark-of-destiny-pharma-discusses-positive-update-from-fda-on-their-xf-73-nasal-gel

If you find this podcast useful please give it a rating and review on iTunes by clicking here

Neil Clark, CEO of Destiny Pharma #DEST Follow | DEST explains the positive update from US FDA, on their XF-73 nasal gel, that will enable simplification of the Phase 3 study design, which is expected to shorten the overall clinical development programme in the U.S.

The key points from the FDA's feedback are:

·    The FDA agreed to the proposed Phase 3 design comparing XF-73 Nasal gel to placebo on top of standard of care for the prevention of post-surgical staphylococcal infections following certain breast surgery operations. This type of surgery is being proposed as patients can experience a relatively high infection rate following the current standard of care and there is a clear unmet medical need.

·     The FDA is open to the collection of microbiological data during the proposed Phase 3 study that could lead to the development of a surrogate marker for clinical efficacy in other types of surgery.

·   Based on the favourable safety profile from the clinical development programme so far, the FDA has confirmed that no specialised nasal examinations are needed in the Phase 3 study. In line with the above, the FDA has also removed the previous requirement to clinically evaluate skin sensitisation.

·     The regulatory feedback will enable Destiny Pharma to simplify the Phase 3 study design and is expected to shorten the overall clinical development programme in the US.

To read full the RNS click here

 

Disclaimer & Declaration of Interest

The information, investment views and recommendations in this article are provided for general information purposes only. Nothing in this article should be construed as a solicitation to buy or sell any financial product relating to any companies under discussion or to engage in or refrain from doing so or engaging in any other transaction. Any opinions or comments are made to the best of the knowledge and belief of the writer but no responsibility is accepted for actions based on such opinions or comments. Vox Markets may receive payment from companies mentioned for enhanced profiling or publication presence. The writer may or may not hold investments in the companies under discussion.

Recent Articles
Watchlist