Interesting reading in the recent Edison research report. Mention of IND application to FDA in Q4 23 for urosepsis. From results to date it does appear urosepsis may be a more immediate potential target. I guess no way to know if this is based on any information from the company but would assume it is a sponsored or paid for report.
The company now plans to start a Phase Ib/IIa multiple-dose study in healthy volunteers in H1 CY23, assessing the drug’s safety, tolerability and pharmacokinetics. Study completion is aimed for H2 CY23 and we expect the company to submit an IND application to the US FDA in Q4 CY23 and start a multiple-dose Phase II efficacy study in urosepsis in CY24. About 25% of sepsis cases are believed to originate in the urinary tract. While this planned Phase II efficacy study will concentrate on urosepsis, we assume that if results are positive, the pivotal Phase III programme (and overall commercial sepsis programme) will include all forms of sepsis. We anticipate the IV drug formulation to start pivotal Phase III sepsis studies (in Europe and the United States) in 2025 and, if approved, be commercialised in 2028.
RCE Price at posting:
60.0¢ Sentiment: None Disclosure: Held
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