Met dank aan Sanderus Beursig
Bron KBC Securities
TIGENIX Feedback Cx601 phase 3 conference call
News:
During yesterday’s webcast, Tigenix provided further details on the Cx601 phase 3 study. Buy rating & TP maintained.
Some additional comments:
Baseline statistics
- The average age of patients in the trial was 38y, showing this is a disease targeting young adults. This is important as it may warrant a higher pricing.
- At baseline, half of the patients in the Cx601 group have more 'complex' fistula, versus only 31% in the placebo group. Despite this difference, Cx601 still showed statistical superiority.
- The majority of patients have received anti-TNF treatment, indicating refractory patients.
- Cx601 and placebo were administered by the surgeons, who were unblinded. Nurses and gastro-specialists doing the evaluation were blinded.
Safety
The most interesting detail was that the number of Treatment-emergent adverse events in the active group were numerically, but not statistically significant lower than the placebo group (16% vs. 26% in placebo), which could give Cx601 next to the efficacy benefit also a safety benefit over standard of care.
High placebo effect
All patients had a cleaning of the fistula and best standard of care, which improves both the placebo and active response rate. However, the high % of single fistula in the placebo may have contributed to the high placebo effect.
Capital needed:
During an interview in De Tijd, Tigenix' chairman stated € 30-40m is needed to execute the plans in the coming years. The money will have to come from a partnering deal in the US and a capital increase, which will be clarified over the coming months. A NASDAQ listing is not being excluded.
Others/Next steps:
- There will be follow-up assessments at week 36 and 52 (including MRI).
- European marketing: Tigenix plans to set up own organizations in certain countries, in others via distributors.
- Previously, pricing of € 20k was guided, but this was not reiterated.
- EU: Regulatory filing in 1Q16, anticipated approval 1H17, launch 2H17.
- US: Finalize tech transfer to US CMO (Lonza) in 2H16, initiate Phase III in the US, endorsed by the FDA under SPA in 2H16, anticipated approval and launch in the US by 2020.
Conclusion:
Key details of the phase 3 study will be presented in March at a leading European conference. Based on the current achievement, we expect Tigenix will increasingly pop up on investor’s radar screen which should be supportive for the stock. Buy rating and € 1.5/sh target price reiterated