I wrote again on $MLTX in Nov. 2023
https://t.co/ilDcTePkQY
MoonLake’s credibility takes another hit with mid-stage study spin job
MoonLake Immunotherapeutics, a Swiss biotech, was buried Monday under an avalanche of its own data spin.
It’s been awhile since I encountered a management team that speaks so arrogantly about the supposed supremacy of its own drug, but then fails to back up the talk with real data. MoonLake claimed its experimental antibody called sonelokimab delivered “landmark” results in a mid-stage study of psoriatic arthritis.
Landmark? That’s a strange way of describing the results of a clinical trial that showed sonelokimab topping a placebo — an easy hurdle — but failing to separate from an active treatment comparator, the generic drug adalimumab (known better as Humira).
Two different doses of sonelokimab given over 12 weeks induced skin-clearance response rates of 46% and 47%, respectively, in patients with psoriatic arthritis, compared to 20% for a placebo. The result was statistically significant, achieving the main goal of the study, but the mid-20% difference was far lower than hoped.
On a conference call Monday, MoonLake executives said the placebo in its study was more effective than anticipated, while continuing to insist its drug is best in class. But real data — not the dozens of spin-heavy slides presented by the company — reveal a more sobering reality.
Bimzelx, an antibody treatment that is made by UCB that was recently approved for psoriatic arthritis, showed a 35% skin clearance rate (placebo adjusted) in its own Phase 2 study.
Acelyrin, a smaller biotech developing an experimental antibody similar to sonelokimab, showed a placebo-adjusted skin-clearance response rate of 39% in a mid-stage study.
Back to adalimumab, for a moment. MoonLake made a big deal about the rigor of its mid-stage study including an active treatment comparator — the only way to truly assess the efficacy of sonelokimab, it argued.
And then MoonLake buried the actual skin-response data comparing sonelokimab to adalimumab in the footnotes of its slides. On one measure, 43% of psoriatic arthritis patients showed a response to adalimumab — barely indistinguishable from the 46% and 47% response rates for MoonLake’s drug.
When it came time for the Q&A portion of Monday’s call, MoonLake executives asked and answered their own pre-screened questions. This was right before MoonLake CEO Jorge Santos da Silva dropped hints about pursuing “strategic opportunities” with potential partners, or … ahem … acquirers.
Monday’s data and management performance were very much like what MoonLake pulled off last June with sonelokimab data in another autoimmune disease called hidradenitis suppurativa.
The difference this time: Investors can see through the boasts.
