Equity research Pila Pharma: XEN-D0501 returns to the clinic, with higher exposure now in focus

Pila Pharma has moved from regulatory approval to clinical initiation, with the first PP-CT04 site (a clinical trial in people living with obesity) now activated.  Hence, enrolment is commencing for the eight-participant Part 1 safety cohort. This progress closes the timing gap highlighted in our recent update, when the company had approval to proceed but had not yet provided a start date.

The study will escalate XEN-D0501 from 4 mg to up to 16 mg twice daily, followed by an eight-week maintenance period. The key question is whether the tablet can deliver materially higher exposure over a longer treatment period without unacceptable TRPV1-related tolerability effects. Part 1 is primarily a safety and pharmacokinetic bridge.  As we have previously stated, any reported effects, e.g., weight loss, will be closely monitored and will likely influence valuation and share price. We should, however, bear in mind that the sample size is small and that, therefore, the study, like other Phase 1b/Phase 2a trials, is unlikely to provide a statistically robust efficacy readout.

In sum, we view the site activation as a positive development step and expect project news flow to increase. The company has previously communicated that Part 1 is financed, while additional capital will be needed to complete the full study, including Part 2. For now, we stick to the base-case valuation of around SEK 2.6 per share but see potential for an upgrade once we have more details on recruiting, funding, and timelines.

Read our latest update here.

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