This is the online version of Adam’s Biotech Scorecard, a subscriber-only newsletter. STAT+ subscribers can sign up here to get it delivered to their inbox.
Gossamer Bio will be reporting the outcome of a Phase 3 clinical trial in pulmonary arterial hypertension, a progressive lung disease, before the end of February. I’m watching this readout with particular interest because it could help answer one of my favorite biotech questions: Is it ever a good idea to run a Phase 3 study based on a “positive” post-hoc subgroup observed in an otherwise negative Phase 2 study?
Never, would normally be my skeptical, absolutist answer, except I’m trying to be more open-minded in my older age. Look at Nektar Therapeutics, which has a drug that was given up for dead but might actually prove to be a blockbuster. It can happen. And in Gossamer’s defense, the Phase 2 study results were modest and disappointing, not an outright failure. The company’s explanations for the mid-stage setback — too many stable, low-risk patients enrolled and Covid pandemic disruptions — are also not unreasonable.
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
