Roche-Atea’s Covid-19 pill fails mid-stage trial, clouding future for closely watched program

Jean-Pierre Sommadossi, Atea CEO

October 19, 2021 08:28 AM EDTUpdated 10:38 AM

Roche-Atea’s Covid-19 pill fails mid-stage trial, clouding future for closely watched program

Jason Mast

Editor

When Merck announced this month that its Covid-19 pill cut newly diagnosed patients’ risk of being hospitalized by 50%, researchers and analysts hoped that other pills would soon prove similarly effective. They paid particular attention to two drugs from Pfizer and Roche.

But on Tuesday, Roche and its biotech partner, Atea, announced that their antiviral had failed a key interim test.

In a Phase II trial, AT-527 didn’t reduce the amount of virus in mild to moderate Covid-19 patients any more than a placebo pill did. That was true for both the patients who received a high dose and those who received the low dose.

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December 7, 2021 07:00 AM ESTUpdated 03:54 PM

People

Special

Special report: Meet 20 extraordinary women who are supercharging biopharma R&D

Endpoints Staff

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Optimizing Oral Drug Delivery using Zydis® Orally Disintegrating Tablet Technology to Address Patient Challenges

Catalent

KEY POINTS

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Geoffrey Porges (SVB Leerink)

December 6, 2021 09:52 AM EST

Deals

Bioregnum

The 2022 wave coming? Top analyst says Big Pharma will have more than $1T available to satisfy its growing appetite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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ENDPOINTS CAREERS

Lead Manager / Associate Director of Statistical Genetics

Deep Genomics

Boston, MA, USA

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December 7, 2021 11:00 AM EST

R&D

Merck pumps the brakes on two more PhIII trials for its lead anti-HIV drug

Zachary Brennan

Senior Editor

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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December 7, 2021 10:27 AM EST

Coronavirus

Covid-19 roundup: Plant-based shot proves safe, 71% efficacious in PhIII; Bourla expects antiviral to launch this month

Zachary Brennan

Senior Editor

Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil.

In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said.

Tedros Adhanom Ghebreyesus (Denis Balibouse/Pool Photo via AP Images)

December 6, 2021 06:01 PM EST

Coronavirus

WHO recommends against the use of convalescent plasma for Covid-19

Zachary Brennan

Senior Editor

The World Health Organization said late today that it’s not recommending the use of convalescent plasma as a treatment for Covid-19 for mild or severe cases, but some U.S. experts disagree with the recommendations and say there are patients who can benefit from the plasma of those who’ve recovered from Covid-19.

The recommendation is informed by a review of 16 RCTs and a “meta-analysis on antibodies and cellular therapies for covid-19,” the WHO said, adding in a statement:

Bolt Bio CEO Randy Schatzman

December 6, 2021 10:59 AM EST

R&D

Bolt Bio goes bust as investors boo single response in early test against HER2-expressing tumors

Kyle Blankenship

Managing Editor

Bolt Bio’s BDC-1001, an antibody conjugate drug designed to amp up the body’s innate immune system response to tumors, posted a single partial response in a Phase I/II study in patients with HER2-expressing solid tumors after a year of dosing. Just 13 of 40 evaluable patients showed any signs of “clinical activity,” the biotech said Monday.

BDC-1001 links a HER2-targeting biosimilar of Herceptin with a TLR7/8 agonist, which is designed to activate myeloid cells in the innate immune system and drive tumor cytotoxicity, Bolt said. But the early results paint the picture of a drug with little effect on HER2 tumors, one of the most highly validated tumor targets in drug development.

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Executive Director - Data Analysis - Science & Technology

Alexandria Real Estate Equities

Pasadena, CA

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Biohaven CEO Vlad Coric (Photo Credit_ Andrew Venditti)

December 6, 2021 10:50 AM ESTUpdated 11:13 AM

R&D

Biohaven shakes up leadership team as it feels the heat from migraine competitors

Josh Sullivan

Associate Editor

As Biohaven Pharma comes off a rollercoaster pipeline year, its CEO will take on more responsibility in a full C-suite makeover.

Vlad Coric was unanimously elected to the role of chairman of the board of directors, after Declan Doogan’s retirement. Matthew Buten will take over the role of CFO after James Engelhart’s retirement, and director Michael Heffernan has been appointed lead independent director. All of the appointments are effective immediately, a company press release said.

December 6, 2021 07:08 AM EST

Coronavirus

Gilead recalls 2 lots of Veklury after investigation confirms complaint of glass particulates

Josh Sullivan

Associate Editor

Two lots of the Covid-19 treatment Veklury have been recalled by Gilead, the company said last week, after the appearance of glass particulates. A customer complaint was confirmed by Gilead’s investigation.

Veklury, also known as remdesivir 100 mg for injection, is used in more than half of hospitalized patients with Covid-19, according to Gilead. It raked in around $2.8 billion last year, and was the only drug approved by the FDA for this setting. But a study out of Europe dubbed DisCoVeRy found that no clinical benefit was observed in patients who received the drug over those who got standard of care alone. And while previous studies have linked remdesivir to a faster time to recovery, that result was not seen in the DisCoVeRy trial.