The data from Inflarx NV that took Wall Street by surprise also served to heighten attention for the hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU) spaces, where other news has been bubbling lately on the industry as well as scientific fronts.
Backers of Jena, Germany-based Inflarx NV have turned their attention to the rest of the pipeline after the stock-jolting news from an independent data monitoring committee (DMC) responsible for the unblinded interim analysis of the phase III trial with vilobelimab in pyoderma gangrenosum (PG). The panel recommended stopping the trial due to futility, although no adverse events were noted in the analysis, which was carried out on the first 30 patients who signed up for the experiment.
The EMA has changed its mind about an earlier decision that the risks of Leqembi (lecanemab) outweigh the benefits and is now recommending the Alzheimer’s disease drug is approved for a subgroup of patients. That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.
The official end of the COVID-19 public health emergency in the U.S. in May did not mark the end of interest and investment in the area. In the shifting landscape, attention has pivoted to new markets, emerging strains, boosters, and the commercialization and distribution of COVID-19 vaccines and therapies.
Despite an early stumble, the U.S. FDA granted emergency use authorization (EUA) to the C5a inhibitor Gohibic (vilobelimab) from Inflarx NV for treating COVID-19 in hospitalized adults. A year ago, an initial phase III analysis had failed to show a statistically significant effect on the primary endpoint of 28-day all-cause mortality though there was a relative reduction in mortality in the active arm vs. placebo.
Inflarx NV is poised to apply for U.S. FDA emergency use authorization for its complement inhibitor, vilobelimab, in treating seriously ill, mechanically ventilated COVID-19 patients, following a reappraisal of the statistical analysis of the 369-patient placebo-controlled phase III trial.
A phase II/III trial testing Inflarx NV's vilobelimab, a monoclonal antibody the company is developing to control inflammatory response, showed a relative reduction in 28-day all-cause mortality of 23.9% vs. placebo (p=0.094) for mechanically ventilated COVID-19 patients, but missed statistical significance on the measure, the study's primary endpoint.
Inflarx NV has submitted a special protocol assessment (SPA) to the FDA for the phase III trial with vilobelimab against the skin disorder hidradenitis suppurativa (HS), pleasing investors with clarity regarding the path forward for the drug, which is in the works for antineutrophil cytoplasmic antibody-associated vasculitis (AAV) as well – and faces competition on both fronts.
