Covid-19 roundup: Pieris to investigate treatment of long Covid with Bavarian grant money; A rollercoaster year ends in FDA OK for repurposed Covid drug
Another respiratory drug is being developed for the treatment of Covid-19.
Pieris Pharmaceuticals announced Friday that the inhaled CTGF inhibitor PRS-220, originally being developed for the treatment of idiopathic pulmonary fibrosis, received a grant from the Bavarian Ministry of Economic Affairs to develop that same agent to treat “long Covid.”
CTGF is a protein in the extracellular matrix, and a driver of fibrotic tissue remodeling that comes from the wound healing process. IPF affects more than 3 million people in the world, and 130,000 in the US, Pieris said in its release. The average survival time for a patient diagnosed with IBF is two to five years.
“The critical function of CTGF in fibrosis, as well as its induced expression upon tissue injury and fibrotic remodeling, render it a compelling intervention for PASC-PF,” the release said. “Persistent symptoms following severe COVID-19 have been reported by different studies in more than one third of hospitalized patients.”
Right now, there’s no approved treatment for post-acute sequelae of SARS-CoV-2 infection, the official name of long Covid.
The grant will support Phase I clinical development and good manufacturing practice manufacturing, Pieris said in the release. Preclinical data is expected to be presented later in 2021.
“The health consequences of the COVID-19 pandemic will affect our health system for a long time to come. Bavaria’s biotech and pharmaceutical companies are at the forefront of developing new therapies to combat the effects of this virus,” Huber Aiwanger from the Bavarian Minister of Economic Affairs said in the release. “Through the strategic grants of the Bavarian Ministry of Economic Affairs, we are providing financial support for particularly innovative therapeutic research projects.”
In May, Pieris Pharmaceuticals added a deal with Genentech worth $20 million upfront, four years after striking an up to $2 billion respiratory partnership with AstraZeneca.
Pfizer’s rheumatoid arthritis drug tofacitinib has also been tested in patients with Covid-19.
Last week, Pfizer announced that the drug reduced the risk of death and respiratory failure in hospitalized patients through 28 days, according to data published in the New England Journal of Medicine. — Josh Sullivan
A rollercoaster year ends in FDA OK for repurposed Covid drug
Nearly a year after Roche announced their IL-6 drug Actemra failed to help hospitalized Covid-19 patients in a large trial, the FDA has given the molecule an emergency use authorization to treat hospitalized Covid-19 patients.
The EUA caps nearly 18 months of head-spinning news for the rheumatoid arthritis drug; distressed doctors turned to it in the early months of the pandemic, prescribing it off-label for patients who had no other options, only to learn when trial data came out last summer that it likely had little effect. Then, in the winter, more data emerged, making a left-for-dead drug look strangely alive.
The FDA’s decision is likely based largely on two large studies. In February, the UK’s nationwide Recovery trial announced that, across just over 2,000 patients, Actemra reduced the number of deaths compared to placebo by 4 percentage points. Later that month, the international academic-run REMAP-CAP trial, using a more complex statistical analysis, published data similarly showing that treating hospitalized patients with Actemra or Sanofi’s IL-6 Roche drug reduced the risk of dying. (They made the first superiority announcement in November.)
Although the decision comes after the pandemic has died down in much of the US, the drug could still provide a key tool as a new variant and slow vaccination rates drive hospitalizations in areas such as Missouri. Although its benefits are relatively modest, it is only the second drug — after the generic steroid dexamethasone — shown to improve survival for all hospitalized patients in large, controlled studies.
The move also points again to the pivotal role large, academic or government-led studies have played in the pandemic, collecting data — and ultimately answers — from a far greater number of patients than the industry-led trials that dominate in the US. The Recovery trial also gave the world the first data showing dexamethasone could boost survival, that Regeneron’s antibody cocktail could boost survival for a subset of hospitalized patients, and some of the first data suggesting hydroxychloroquine doesn’t work in that setting. — Jason Mast
Two Chinese vaccines appear less effective against Delta variant
More bad news on the Delta variant: Two major Chinese-produced vaccines, from Sinovac and Sinopharm, appear less effective in lab studies against the new strain but still offer some protection, Reuters reported.
The news, relayed by a Chinese disease control researcher to state media, comes as little surprise. Data from the UK already suggested the new variant can evade some of the antibodies produced by Pfizer’s vaccine.
But whereas Pfizer’s vaccine was effective enough that a slight downtick had little impact — it was still 88% after two doses — the Sinopharm and Sinovac vaccines were less effective to begin. The latter only offered about 50% protection.
The Chinese disease control researcher said the shots still offered protection against the variant, but didn’t clarify what degree of protection. He said, however, that during a recent outbreak in three cities in Guangdong province, none of those hospitalized had been vaccinated. — Jason Mast
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