As Warren Buffet says: Rule one of Investing don’t lose money
Rule two don’t forget the first rule.
I considered investing in Invex Therapeutics, but in the end, I didn’t, which I’m now glad about.
On the outside, the company was a perfect; orphan indication, a repurposed drug with a known safety profile, strong Phase 2 results, Strong shareholding, strong experienced management and a board of directors fully funded for Phase 3, But ultimately they didn’t continue on with their trial there were many issues from clinical trial design and competition.
One of the main issues was the clinical trial design, which failed to achieve harmonisation between the FDA and EMA for their Phase 3 trial. Additionally, the chosen outcomes required measurements of Idopathic Intercranial Hypertension via an Lumbar Puncture, rather than focusing on patient outcomes as the primary outcome. Even if the numbers were good, without improved patient outcomes, the EMA agreed that the trial would fail, while the FDA did not.
Another reason for the trial’s cancellation was the rise of SLGTi, which had a similar effect to Exenatide, a GLP1 receptor agonist. The inclusion criteria were so strict that it was impossible to recruit patients for the trial. Fortunately, the management and board were proactive; they reviewed the market for the product, realized the challenges they faced, stopped the trial, and returned capital to shareholders.
Overall, Invex Therapeutics faced multiple factors that contributed to the trial’s failure, despite having a capable team and promising Phase 2 results.
Investing in Health 