Zilosul is the name for Paradigm’s flagship trial drug, injectable pentosan polysulfate sulfate (iPPS).
Paradigm is progressing through regulatory processes in multiple regions being Australia (TGA), the US (FDA), and Europe (EMA).
There are a number of clinical development and regulatory milestones upcoming including:
- US pre-IND FDA meeting in February;
- Proceeding with the provisional determination assessment process based on November TGA meeting;
- Preparing FDA (US) and EMA (Europe) joint parallel advice application for submission to discuss the MPS Phase 2/3 Clinical Trial in March quarter;
- Report update for Australian SAS program in June quarter; and
- Commence EAP treatment program in January.
Presenting at upcoming conferences
Paradigm will also be attending the h JP Morgan Healthcare conference in San Francisco during January and the WORLD Symposium 2020 Lysosomal diseases research and conference in February.
The company has already secured a number of meetings with specialist US Biotech or healthcare Funds attending the San Francisco conference.
Furthermore, Paradigm has been selected to present a poster detailing outcomes from patient research advisory group informing its phase 2/3 clinical trial design at the WORLD Symposium.
Paradigm has appointed Dr Donna Skerrett as its chief medical officer based in New York who has extensive experience with US FDA IND filing.
The company has also expanded its investor relations team hiring Mitch Marrow in the US and Simon White in Australia to start in January 2020.
Both have extensive financial industry experience and are high profile ex elite sportspeople.