Late-Stage Clinical Study Readings Biotech Investors Should Watch Out For
VSlinear updates can provide major catalysts for pharmaceutical and biotechnology actions. In this Motley Fool Live video registered on June 30, 2021Motley Fool contributors Keith Speights and Brian Orelli discuss some advanced clinical readings underway this year that investors should watch closely.
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Keith Speights: Brian, several drugmakers have fairly large Phase 3 data readings going through the third trimester, or around the third trimester. Are there any that you think investors should particularly watch closely?
Brian Orelli: Shrinking it down to a quarter is a bit difficult because obviously companies don’t always give you that exact timeline. A lot of times it’s “the second half of the year” or even “in 2021”, but it hasn’t happened yet, so we know it’s going to happen soon, but we don’t know exactly when.
I looked at the new immune checkpoint inhibitors. We haven’t had a big win since PD-1s hit the market a few years ago. Novartis (NYSE: NVS) has an antibody targeting TIM-3 called sabatolimab which is expected to read a phase 2 trial in myelodysplastic syndrome in the second semester. This is one that I really watch.
Biogen (NASDAQ: BIIB) and Therapeutic sage (NASDAQ: SAGE) have more data on Zuranolone. They had phase 3 data earlier this month, I believe, from the WATERFALL study in major depressive disorder.
The data was mixed. He passed the clinical trial, but investors were concerned about the scale of the results and whether there would be a long-term effect. They have a second phase 3 called LANDSCAPE, also in major depressive disorder, which combines their medication with an antidepressant versus an antidepressant alone.
Maybe you get less placebo effect for this comparison because now everyone knows they have the drug – some people have two drugs and some have only one, but everyone know they are at least getting something to help them benefit. Maybe this helps us see the real benefit of the drugs from Biogen and Sage.
They’re also testing the drug in a Phase 3 clinical trial called NEST, which is in postpartum depression, and I think the readings for both are expected this year, or maybe they’ll be moved to early in. next year.
Pfizer (NYSE: PFE) and rock (OTC: RHHBY) have data coming up for their gene therapy to treat hemophilia B. The timing is a little less certain, but it might come this year, maybe early next year.
They’re going to look at the 12-month data. What you will be looking for here is factor IX expression, which is what patients with hemophilia B lack, and then also the annualized bleeding rates are going to be significant, at least in the first 12 months.
It will compete with UniQure (NASDAQ: QURE), who already has gene therapy that has already read phase 3 data for one-year expression. Factor IX expression was 41.5% of normal and annualized bleeding rates were reduced by 85%, so this is the level Roche and Pfizer are going to have to meet or exceed.
UniQure said the FDA now wants 18-month data before it can submit it to the FDA, so it seems likely that Pfizer and Roche may also need the 18-month data. So we should look not only at the data but also [are] Pfizer and Roche say when will they be able to seek FDA approval for their gene therapy.
Speights: Brian has been covering the biotech space for a long time, so if you’re interested in biotech stocks, these are clinical readings you’ll definitely want to pay attention to since they’re on his radar screen.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.