Equity research Pila Pharma: Receives go-ahead for start of obesity trials

Pila Pharma reports that it has received EMA approval to start a clinical trial to evaluate the safety and tolerability of increasing doses of XEN-D0501 versus placebo over 12 weeks of dosing in obese participants. We are encouraged that the start of clinical development in obesity at higher and potentially more clinically relevant doses now appears near, somewhat ahead of our previous assumptions.

XEN-D0501 to be administered at higher, potentially more efficacious, doses

The news marks a significant step for Pila, as the new clinical trial, PP-CT04, is intended to move XEN-D0501 into a longer, higher-dose study in people living with obesity. The company states, “As we mentioned before, higher doses and longer treatment durations are considered necessary to achieve good efficacy.” Participants will be individually titrated from 4 mg twice daily to a maximum of 16 mg twice daily, with each dose level administered for 1 week, followed by an 8-week maintenance period at the highest tolerated dose.  The primary endpoints are safety and tolerability, and secondary endpoints include the effect on body weight, body composition, and waist and hip circumference of 12 weeks of dosing with XEN-D0501 vs placebo.

Following screening for potentially eligible participants, we would expect the first patient to be dosed soon. The first part will function as a pilot safety cohort with 8 participants randomised 3:1 to XEN-D0501 (6 participants) or placebo (2 participants). Part 2 will comprise the remaining 38 participants, randomised 1:1 to XEN-D0501 (19 participants) or placebo (19 participants).

The release states that an agreement was entered into with a CRO to conduct Part 1, which will proceed without additional capital. However, as we discussed in the initial coverage report, we have assumed that additional capital will eventually be required for clinical development. At the same time, the approval enables a somewhat earlier start of the first part of the trial than we had previously assumed.

More frequent project updates could drive the share price going forward

To conclude, we look forward to the testing of higher doses for a longer period in obese patients. Also, we expect a more frequent project news flow going forward, including the dosing of the first patient and other updates from the initial part of PP-CT04. Needless to say, any reported effects on, e.g., weight loss will be followed closely and will likely heavily 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.  We will likely review our forecast and valuation assumptions in the near future (current base case valuation: SEK 2.5 per share), following the Q2 2026 report and potentially more details regarding timelines and trial planning.

Read our latest update here.

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