BioPharma, Pharma

InflaRx Covid-19 Drug Welcomes an FDA Win; Pardes Bio Throws In the Towel

The FDA granted emergency use authorization to an InflaRx antibody drug that treats hospitalized Covid-19 patients. But Pardes Bioscience’s coronavirus journey is ending following the Phase 2 failure of an antiviral that was expected to compete with Pfizer’s Paxlovid.

Covid-19 antibody drug developers have had a rough time. One by one, antibody medicines that reached the market under emergency use saw their authorized indications narrowed and then revoked by the FDA due to ineffectiveness against newer strains of the virus. By the end of last year, no Covid-19 antibody drugs remained authorized for use in the U.S.

InflaRx is showing that Covid-19 antibody drug research is still alive. The FDA this week authorized the biotech’s antibody, vilobelimab, as a treatment for Covid-19 in hospitalized adults. The drug is meant for severe cases. The authorization specifies treatment must start within 48 hours of the patient receiving mechanical ventilation or artificial life support. Jena, Germany-based InflaRx will market its new product under the name “Gohibic.”

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The antibody drugs whose authorizations were revoked all targeted some part of SARS-CoV-2 in order to prevent it from infecting cells. InflaRx’s target isn’t on the virus. The biotech’s antibody addresses a part of the immune response believed to play a role in the inflammation that leads to Covid-19 progression. The drug targets C5a, a protein of the complement system, which is a part of the immune system.

Authorization of InflaRx’s drug provides an alternative to Olumiant, an Eli Lilly drug. Like Gohibic, Olumiant is also authorized for treating hospitalized patients within 48 hours of starting mechanical ventilation or artificial life support. This Lilly drug works by blocking JAK proteins associated with inflammation. But Olumiant is a small molecule made into a pill—a challenging formulation for patients receiving breathing assistance. Olumiant can be dissolved in water and swallowed or administered via a gastrointestinal tube. But InflaRx’s Gohibic provides yet another dosing option, as that drug is administered as an intravenous infusion.

InflaRx initially developed its antibody as a treatment for hidradenitis suppurativa, a rare inflammatory skin disorder. In 2019, the antibody drug failed a Phase 2b test in that indication. With the onset of the pandemic the following year, InflaRx began a clinical trial testing the antibody in Covid-19 patients.

The Gohibic EUA request was based on data from a placebo-controlled Phase 3 study that enrolled 369 mechanically ventilated patients in intensive care units. According to study results, after 28 days, the treatment group showed a 23.9% reduction in death from all causes compared to the placebo arm. The most common adverse reactions reported in the study included pneumonia, sepsis, delirium, and pulmonary embolism. The FDA also said serious infections have been reported in Covid-19 patients who received Gohibic.

Now that InflaRx has emergency authorization for Gohibic, the company said it is communicating with the FDA about the next steps for a biologics license application seeking full regulatory approval. The company is having similar discussions with regulators in Europe.

Pardes Explores Strategic Alternatives After Antiviral Fails Phase 2

Meanwhile, it looks like the end of the road for another Covid-19 biotech company, Pardes Biosciences. Carlsbad, California-based Pardes this week reported data showing its antiviral drug, pomotrelvir, did not meet the main goal of a Phase 2 study.

Pomotrelvir is a small molecule designed to inhibit main protease, or Mpro, the same viral enzyme addressed by the authorized Pfizer Covid-19 drug Paxlovid. It must be taken with another medicine that slows the breakdown of Paxlovid, keeping it in the body for longer and at higher concentrations. But this drug regimen requires patients to take extra pills. Pardes aimed to bring patients the benefits of blocking Mpro without the need for additional pills to help its drug work better.

The placebo-controlled Phase 2 test enrolled 242 adults with mild-to-moderate Covid-19. The main goal was to measure the proportion of trial participants who reached undetectable viral levels. According to the preliminary results, 70% of patients in the treatment arm achieved that mark compared to 63% in the placebo group—not enough to be meaningful. Pardes is continuing to analyze the results, which it said will be submitted to a scientific conference or peer-reviewed publication to contribute to the field’s understanding of SARS-CoV-2 and the development of Covid-19 drugs.

Given the Phase 2 failure, Pardes is stopping further clinical development of pomotrelvir and it has begun a review of strategic alternatives that could include an acquisition or a merger with another company. As is typical of companies undergoing such reviews, Pardes said it would not comment unless or until its board of directors has determined a course of action.

In a regulatory filing, Pardes said it is laying off 85% of its workforce in phases, starting this month. The estimated costs associated with layoffs is $5.7 million. As of the end of the first quarter of this year, Pardes reported its cash position was $172.4 million.

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