| |   | Meghana here. This week, we’re on the lookout for a new trove of Alzheimer’s data from Biogen and Eisai, we see the makings of a new IPO, and we learn about a new wave of viral vectors. | | | A readout on lecanemab nears The world is likely to learn the results of a closely watched Alzheimer's trial this week, as Biogen and its partner Eisai prepare for a readout of lecanemab, their next amyloid-targeting therapy.
The medicine, like its controversial predecessor, aducanumab, targets amyloid plaques. And, as with aducanumab, success isn't necessarily going to be as clear-cut as one might think. “I’m thinking any kind of clinical response might be meaningful in terms of that’s all we can expect from that type of intervention at that stage of the disease process,” one neurologist told STAT. CLARITY-AD, the Phase 3 trial whose readout we’re awaiting, is the largest-ever Alzheimer’s study — enrolling 1,900 patients with early-stage disease. Given the dearth of treatments for neurodegenerative diseases, even a moderate proven benefit could prove valuable for patients.
STAT's Adam Feuerstein and Damian Garde break down everything you need to know in advance of the readout.
Read more. | New viruses probed for gene therapy potential So-called anelloviruses are famous for their virality: They’re known to spread rapidly and completely, reaching each and every corner of a host’s body. But although our bodies are saturated with them, anelloviruses are harmless — so scientists have largely neglected studying them. If they aren’t hurting anyone, what’s the point? Well, gene therapy companies are now seeing value in these ubiquitous bugs. Biotechs like the Flagship-backed Ring Therapeutics think anelloviruses would be perfect tools to ferry engineered gene therapies to cells throughout the body. The field has relied almost exclusively on adeno-associated viruses, or AAVs, but this new class of microscopic invader could change the gene delivery game for the first time in decades. But there’s a lot of basic science yet to be done before the wild anelloviruses can be subdued, and used in the clinic. Read more. | In-depth analysis of biopharma and the life sciences Sign up for STAT+ to access in-depth analysis of biopharma, inside intelligence from Capitol Hill, the latest on medicine tech, and more. Subscribe today to and start your free 30-day trial. | European regulators want clinical trials transparency Regulators from seven European countries plan to require that clinical trial sponsors make their study results public. At the same time, three other countries have so far taken little to no action on the issue.
Those are the results of a new analysis conducted by several groups that advocate for greater clinical trial transparency, STAT's Ed Silverman reports. The analysis arrives amid an increasing push to convince regulators and lawmakers to boost oversight of clinical trial results reporting and registrations.
“The good news is that many regulators in Europe are finally taking this issue seriously,” one transparency advocate told STAT. “Transparency of clinical trials data is an important basis to boost research efforts at the EU level where it is needed and therefore make the best use of public money.” Read more. | Prime Medicine files for IPO Big bear market be darned: Prime Medicine, a biotech developing gene therapies for a number of rare inherited diseases, just filed for an IPO.
The company uses “prime editing” technology, which it says can repair many types of mutations, including point mutations, deletion mutations, and insertion mutations. It is, in a sense, a more precise form of CRISPR editing, the company says. Prime is developing gene therapies for sickle cell disease, retinitis pigmentosa, Duchenne muscular dystrophy, ALS, and other diseases. It plans to trade on the Nasdaq under the ticker symbol “PRME.” Just 18 biotechs have gone public since the start of the year, compared to 111 last year. But some investors think there are signs of a comeback: Third Harmonic Bio had a solid showing earlier this month with a $185 million IPO. “My sense is we’ll see the [biotech] IPO market reopen in earnest in early 2023,” one analyst told the Wall Street Journal. We’ll see? | More reads - FDA: Ignore a pharma company’s deceptive racial equity argument for keeping Makena, an ineffective preterm labor drug, STAT
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| Thanks for reading! Until tomorrow,  | | | |
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