The Readout Damian Garde & Meghana Keshavan

Lilly’s Covid-19 antibody looks promising in early data

In the first major test of antibody treatments for Covid-19, a drug from Eli Lilly helped sick patients rid their systems of the virus sooner and reduced the hospitalization rate compared to placebo.

According to interim data from an ongoing trial, one dose of Lilly’s antibody met the trial’s primary goal of significantly reducing patients’ levels of SARS-CoV-2 after 11 days. Two other doses, including a higher one, did not meet that goal. More promisingly, just 1.7% of patients who received any dose of Lilly’s treatment were eventually hospitalized, compared with 6% of those who took placebo, amounting to 72% relative reduction in risk.

The results are preliminary, have yet to be peer reviewed. But they are the best evidence yet that custom-built antibodies may prove effective against Covid-19.

Read more.

What happens when the clock starts ticking on SPACs?

The latest trend in biotech finance is the blank-check company, a publicly traded entity that exists only to find promising private firms and take them public through an IPO-free reverse merger. More than 10 health care-focused blank-check outfits have gone public in 2020 with more waiting in the wings.

But the most recent entrant, a $500 million shell company formed by Patient Square Capital, offers a reminder of the risks involved. Like the vast majority of special purpose acquisition companies, or SPACs, Patient Square’s blank check has just 24 months to find a buyout target and get SEC approval for the merger. If time runs out, it has to return investors’ money and wind the whole thing down.

That may seem like plenty of time to ferret out a promising target, but it’s worth remembering that today’s private biotech firm has a wealth of options for going public, between a vibrant IPO market, stalled companies that can be fodder for reverse mergers, and ever more SPACs. Then there’s issue of market congestion: With so many biotech SPACs going public within weeks of one another, each with a 2022 expiration date, investors might be forced into less-than-attractive deal terms just to beat the clock.

Lawmakers demand drug companies stop threatening safety-net hospitals

A handful of drug companies have threatened to curtail the discounts they provide to a federal program for safety-net hospitals. Now, a bipartisan group of Democratic U.S. senators is demanding they knock it off.

As STAT’s Ed Silverman reports, it all hinges on the government’s 340B drug discount program, which requires drug makers to offer substantial discounts to hospitals and clinics that serve indigent populations. Earlier this summer, at least five major drug companies threatened to withhold those discounts, alleging that hospitals were violating the program’s rules by employing contract pharmacies to dispense those drugs.

In a letter to the trade group PhRMA, 23 senators wrote that “it is troubling that during a time of deep uncertainty involving access to health care, many of your member companies are taking retaliatory actions against” hospitals and clinics, adding that “this coercive behavior is ultimately most harmful to patients and should be reversed.”

Read more.

AstraZeneca’s U.S. vaccine trial is still on hold

Since last week’s news that AstraZeneca had halted enrollment in its Covid-19 vaccine trials over a suspected serious reaction, the company has gradually resumed studies in the U.K., Brazil, and South Africa. But not in the U.S., where the hold appears indefinite.

FDA Commissioner Stephen Hahn, making his first remarks on the matter via Instagram Live, said the agency was “going to do very significant work with the company to figure out if there’s a significant safety issue or not” before the study can start dosing volunteers again.

That complicates AstraZeneca’s plans to have Phase III data available later this year, which could put the company materially behind competing vaccines from Moderna and the partnership of Pfizer and BioNTech. It also underlines just how difficult it is to get clear information on what’s going on. Prior to Hahn’s comments, which came in a live chat with Republican Sen. Tim Scott of South Carolina, the FDA had not publicly acknowledged the pause to AstraZeneca’s trial, and it is yet to provide any details on when the study might resume.

More reads

  • How biotech investors can survive election season. (Wall Street Journal)
  • An inside look at STAT’s First Opinion. (STAT Plus)
  • Germany grants BioNTech, CureVac $745 million to speed up COVID-19 vaccine work. (Reuters)
  • Compass Pathways set to become the first psychedelic biotech IPO. (STAT Plus)

Thanks for reading! Until tomorrow,

Wednesday, September 16, 2020


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