| |   | Good morning, everyone. Damian here with good news for Alnylam Pharmaceuticals, an idea for diversifying clinical trials, and another disappointment in the quest to find new painkillers. | | | Alnylam succeeds in much-anticipated cardio trial Alnylam Pharmaceuticals’ treatment for an increasingly common heart disease succeeded in a closely watched clinical trial, the company said today, clearing the path to approval and affirming the promise of a drug analysts expect to reap blockbuster sales.
The drug, patisiran, met its primary goal in a study enrolling patients with ATTR-CM, a progressive heart disease. In a 12-month trial, patients taking patisiran did significantly better than those taking a placebo on a test of how far they could walk over the course of six minutes. The study met its secondary goal of improving scores on a patient-reported questionnaire on quality of life relative to placebo, and while fewer patients in the patisiran group died or had a heart attack or stroke, the difference wasn’t statistically significant.
The study was one of the drug industry’s biggest expected events for 2022, a year in which biotech stocks have fallen by double digits and underperformed the broader market. Winning approval to treat ATTR-CM could bring patisiran’s peak annual sales to more than $5 billion, according to Ritu Baral, an analyst at Cowen.
Read more. | One under-used tool for diversifying clinical trials: money Diversity in clinical trials has long been dismal, and as a new congressional report illustrates, the result shortened life expectancies, wasted money, and missed discoveries. Three researchers behind that report have a potential solution: Pay people.
Writing in STAT, the researchers point to the established power of financial incentives. Paying trial participants for lost wages, transportation costs, dependent care, and housing could bridge gaps in recruitment.
And even more powerful would be incentivizing the drug industry, whether by providing tax credits, fast-track eligibility, exemption from some FDA application fees, or extended market exclusivity for drugs in exchange for meeting diversity criteria.
Read more. | STAT Event: Creating AI That Improves Health On August 3, hear how researchers aim to create a “data economy” to ensure that artificial intelligence lives up to its promise. Register now to join. | AbbVie’s ‘patent thickets’ survive a legal challenge AbbVie’s pioneering use of patent filings to extend the commercial life of Humira survived a worrisome challenge, as a federal appeals court declined to revive a lawsuit accusing the company of abusing intellectual property law.
As STAT’s Ed Silverman reports, the ruling is a significant victory for AbbVie, which has used what critics call a “patent thicket” to protect its best-selling medicine from competition. Some of the 132 U.S. patents that the company holds on Humira extend to 2034, although the foundational patent expired in 2016.
Humira, approved in 2002, has made billions of dollars for AbbVie and become a poster child for the drug industry’s alleged abuses of the patent system. The treatment is expected to face biosimilar competition in the U.S. for the first time starting next year.
Read more. | Another novel painkiller comes up short Eliem Therapeutics, which raised more than $90 million in an IPO almost exactly one year ago, has lost about 80% of its initial value and is cutting the cord on its once-promising treatment for chronic pain.
The decision, disclosed yesterday, follows ETX-810’s failure to beat placebo in a mid-stage trial enrolling patients with sciatica. In April, the same drug failed in a neuropathic pain study.
ETX-810 was among the few novel, non-opioid pain treatments in the pipeline, designed to spur the body’s production of a lipid that regulates inflammation and reduces neuronal pain signaling. Its failure adds to years of disappointing attempts to develop novel medicines that can outperform old painkillers without the risk of dependence.
Among the lone bright spots was this year’s news that Vertex Pharmaceuticals' experimental pill succeeded in two studies focused on acute pain following surgery. Vertex plans to advance its drug into pivotal studies in the second half of 2022. | More reads - The trust-builder: a cancer center director’s try-it-all strategy for breaking the barriers between research and Black patients. STAT
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- Paxlovid rebound happens, though why and to whom are still a mystery. STAT
| Thanks for reading! Until tomorrow,  | | | |
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