| | | |   | Hello, everyone. Damian here with a deep look at a weighty debate in neuroscience, a bellwether biotech IPO, and news on Eli Lilly's ambitions in Alzheimer's disease. | | | A hotly debated brain sediment could forever change drug development Among the many impediments to finding new drugs for neurological disorders like ALS and Huntington’s disease is the vexing difficulty of figuring out whether a medicine is doing its biological job in the brain. But the emergence of a telltale protein promises to light what is currently a dim corridor of research.
As STAT’s Jason Mast reports, that protein is called neurofilament, and it is, in the words of one scientist, “a universal marker of neuronal death.” Scientists have routinely found elevated levels of blood neurofilament in patients with Alzheimer’s disease, Huntington’s, and other neurodegenerative disorders (and people suffering from traumatic brain injuries).
That suggests measuring neurofilament could be a way to diagnose such diseases more quickly, and to discern whether a given medicine is showing a benefit without waiting on the results of a lengthy clinical trial. And while data tying measurable neurofilament to specific outcomes aren’t yet conclusive, the FDA is about to wade into the issue when considering a pair of potential treatments for ALS.
Read more. | Lilly’s Alzheimer’s ambitions reach into Asia In a vote of confidence for its closely watched treatment for Alzheimer’s disease, Eli Lilly is starting a second Phase 3 study with a particular focus on China, a trial that wouldn’t read out until roughly two years after the company’s pivotal U.S. study concludes.
The new trial, listed online over the weekend, is essentially identical to TRAILBLAZER-ALZ-2, the Phase 3 study expected to read out next year, enrolling patients with mild Alzheimer’s and testing whether Lilly’s donanemab can beat placebo at delaying cognitive and functional decline.
To Tim Anderson, an analyst at Wolfe Research, Lilly’s decision to embark on a costly Phase 3 endeavor before seeing data from TRAILBLAZER-ALZ-2 suggests the company is confident donanemab will work. Lilly’s decision adds another wrinkle to what will be a pivotal 12 months for investigational Alzheimer’s treatments, with data from Biogen’s lecanemab expected next month and pivotal results on Roche’s gantenerumab due before the end of the year. | STAT E-Book: How technology shapes patient experiences Our latest e-book underscores the vast range of technologies that are shaping how patients find and receive health care, from smartphone apps to deliver therapy and bedside bots to channel medication requests to new tools to collect real-world data and wearable watches to detect heart health. These stories illustrate the exciting advances being made on these technologies and highlight the challenges to their broader adoption. Download now. | Testing biotech’s recent resurgence, a company dares to go public Just six biotech companies have executed IPOs in 2022, a dramatic decline from the prior year in which more than 100 firms went public and raised nearly $20 billion in the process. Third Harmonic Bio intends to be the seventh — and first since May — in the latest test of whether biotech’s summer recovery can endure.
The company, headquartered in Cambridge, Mass., is developing a drug aimed at the protein KIT, which plays a role in the body’s immunological response to foreign threats. In its IPO prospectus, Third Harmonic describes its lead drug, THB001, as a “pipeline in a product,” with applications in skin, respiratory, and gastrointestinal diseases.
Third Harmonic’s IPO will be closely watched among the many private biotech companies forced to delay their own plans as 2021’s boom collapsed into a downturn. The XBI index of biotech stocks, once down about 50% in 2022, has recovered in fits and starts since June, making Third Harmonic a potential bellwether for the rest of the year. | Not every premium is precious Aerie Pharmaceuticals, maker of a pair of eye drugs, signed a deal to sell itself to Alcon for $15.25 a share, a 37% premium to its prior closing price, in a deal worth $770 million.
To biotech investors blinkered by a year of red numerals, all accretive buyouts are good news. But for Aerie, the Alcon deal comes in about 9% below the company’s valuation as recently as September 2021.
And while Wall Street had long pressured the company to sell itself or at least its two approved drugs, the final transaction appears to have fallen below expectations. In a note to clients earlier this month, Cowen analyst Ken Cacciatore ran the numbers on Novartis’ recent acquisition of the dry-eye treatment Xiidra and Alcon’s deal for the glaucoma drug Simbrinza and deduced that Aeri could go for $25 a share, or roughly $1.2 billion. | More reads - AstraZeneca may not stay in vaccines, but CEO has no Covid regrets. Reuters
- Moderna to seek FDA approval of booster against Omicron variants. Bloomberg
| Thanks for reading! Until tomorrow,  | | | |
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