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The Readout Damian Garde & Meghana Keshavan

Regeneron’s Covid-19 antibody slashes hospitalization rates

An antibody cocktail from Regeneron Pharmaceuticals significantly reduced the rate of Covid-19 hospitalization or death in a large clinical trial, the company said today. And the treatment appeared to work just as well at half the dose currently in use, which could effectively double the available supply.

In the study, Regeneron enrolled about 4,500 Covid-19 patients who were not hospitalized but had at least one risk factor for severe disease. Patients who got Regeneron’s treatment, either at 1,200 mg or 2,400 mg, were about 70% less likely to end up in the hospital or die from Covid-19 than those who got placebo. And their symptoms went away after 10 days at the median, which was a statistically significant improvement over the 14 days seen with placebo.

The results are yet to be published in a peer-reviewed journal, but Regeneron plans to immediately share its data with the FDA and request the agency update its emergency use authorization to include the 1,200 mg dose. That would double the number of patients eligible for Regeneron’s therapy.

Roche ends its Phase 3 Huntington’s study, another disappointment in a disease with no treatments

Roche halted dosing in a late-stage trial of a treatment for Huntington’s disease, seemingly ending development of a medicine that many patients had pinned their hopes on.

The decision follows the recommendation of Roche’s independent data monitors, the company said yesterday, who recommended ending the study “based on the investigational therapy’s potential benefit/risk profile for study participants.” No new safety concerns came to light in the study, Roche said, and the company intends to continue following patients enrolled in the trial. But the drug, tominersen, will no longer be administered.

Roche’s decision marks the end of the largest Huntington’s clinical trial ever conducted. After tominersen demonstrated preliminary promise in an early study, patients with the rare, devastating disease scrambled to enroll in the Phase 3 trial, hoping Roche’s drug could succeed where so many previous therapies had failed.

Pfizer and Lilly’s long-delayed pain drug finally goes before the FDA

After about 15 years of stop-and-start development, a chronic pain treatment from Pfizer and Eli Lilly is up for an FDA hearing, one that might slam the door on a new class of medicines once thought to be revolutionary.

On Thursday, a group of FDA-selected experts will review the evidence behind tanezumab, an injectable treatment meant to relieve pain by interrupting the natural process for signaling to the brain. Medicines like tanezumab, called NGF inhibitors, have proved to be effective painkillers, but each has been dogged by safety concerns related to rare but serious cases of joint damage. In documents posted before Thursday’s meeting, FDA reviewers expressed concern that Pfizer and Lilly’s plan for safety monitoring wouldn’t be sufficient to minimize that risk.

If the FDA’s advisers recommend against approving tanezumab, it could signal the end of the road for NGF inhibitors, once perceived as a promising alternative to opioid therapy before the risk of joint damage dimmed their prospects. Partners Regeneron Pharmaceuticals and Teva are awaiting long-term safety data on an NGF treatment of their own, but analysts believe that drug’s future hinges on the FDA’s reaction to tanezumab.

An FDA meeting so negative it put a company out of business

Odonate Therapeutics, a New York-based oncology company, had big plans for 2021. The company had just raised about $80 million in a stock sale and, as CEO Kevin Tang said as recently as February, it was on track to submit its treatment for breast cancer to the FDA by the middle of the year.

Then Odonate actually talked to the FDA, and now it’s going out of business. In a 113-word press release issued yesterday, the company packed in a lot of news. First, that meeting with the FDA led Odonate to conclude the agency wouldn’t support its case for approval. Next, Odonate decided to discontinue development of its drug, tesetaxel. And, finally, the company is now going to wind down its operations. The release ends with a quote from Tang thanking everyone involved in the tesetaxel trial.

The news sent Odonate’s share price down about 80%, and the company’s market value is now roughly equivalent to its cash balance. What remains unclear is just what the FDA said during that meeting and why it apparently came as such a surprise to Odonate, which was promising to submit tesetaxel for approval just weeks before. Those questions might be of particular interest to the investors who bought into Odonate at four times its current value just last fall.

More reads

  • Digital therapeutics startups are ready for more regulation, not less. (STAT+)
  • Latest biotech flop shows risks of trading in penny stocks. (Bloomberg)
  • Oncology biotech Ikena Oncology sets terms for $125 million IPO. (Renaissance Capital)
  • Lawmakers introduce a bill to prevent Sacklers from using bankruptcy ‘loophole’ to evade liability. (STAT+)

Thanks for reading! Until tomorrow,

Tuesday, March 23, 2021

STAT

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