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Kiniksa (KNSA) COVID-19 Study for ARDS Fails to Meet Main Goal

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Kiniksa Pharmaceuticals, Ltd. (KNSA - Free Report) gave a dismal update on mavrilimumab for addressing COVID-related acute respiratory syndrome (ARDS).

Mavrilimumab is an investigational fully human monoclonal antibody that targets granulocyte macrophage colony stimulating factor receptor alpha (GM-CSFRα).

The phase II/III study is a global, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of mavrilimumab for the treatment of hospitalized, non-mechanically-ventilated adult patients with hypoxia and severe COVID-19 pneumonia/hyperinflammation.

Approximately 582 patients in the phase III portion of the trial were randomized in a 1:1:1 ratio to receive a single intravenous dose of mavrilimumab 10 mg/kg, 6 mg/kg or placebo.

Results from the study showed that the phase III portion of the trial did not meet its primary efficacy endpoint of proportion of patients alive and free of mechanical ventilation at day 29.

Shares of Kiniksa have plunged 31.4% compared with the industry’s 20.4% decline.

Kiniksa was also evaluating mavrilimumab for rheumatoid arthritis through phase IIb clinical studies in Europe and achieved prospectively defined primary endpoints of efficacy and safety. Kiniksa is currently evaluating the next steps for mavrilimumab to treat giant cell arteritis (GCA).

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Following the failure of the phase II/III study for COVID-related ARDS, Kiniksa will now focus its resources on the Arcalyst franchise, as well as the development of vixarelimab and the anti-CD40 program KPL-404.


Arcalyst, discovered by Regeneron, is a weekly, subcutaneously injected recombinant dimeric fusion protein that blocks IL-1 alpha and IL-1 beta signaling. The FDA approved it for recurrent pericarditis, cryopyrin-associated periodic syndromes (CAPS), including Familial Cold Autoinflammatory Syndrome and Muckle-Wells Syndrome, and the deficiency of IL-1 receptor antagonist (DIRA).

Pluristem Therapeutics (PSTI - Free Report) also recently announced disappointing top-line data from the two phase II dose escalation studies evaluating the safety and efficacy of its intramuscular injections of PLX-PAD cells compared with placebo for the treatment of ARDS associated with COVID-19.

The primary efficacy endpoint was the number of ventilator free days (VFD) from day 1 through day 28 of the studies. PSTI stated that both studies did not meet the primary endpoint of a statistically significant improvement of VFD after a 28-day regimen.

Kiniksa currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks include GlaxoSmithKline (GSK - Free Report) and Sarepta Therapeutics, Inc. (SRPT - Free Report) , each carrying a Zacks Rank of 2 at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

GlaxoSmithKline’s earnings per share estimates for 2021 have moved north from $2.81 to $3.05 in the past 60 days. The same for 2022 has increased from $3.15 to $3.25 in the past 60 days. Shares of Glaxo have risen 18.6% in the year so far.

Earnings of Glaxo beat estimates in three of the last four quarters and missed the mark once, with the surprise being 15.3%, on average.

Estimates for Sarepta have narrowed from a loss per share of $6.95 to $4.99 for 2021 and from $4.83 to $3.61 for 2022 in the past 60 days.

SRPT delivered an earnings surprise of 11.06%, on average, in the last four quarters.