Shares in InflaRx closed 6% higher on Tuesday after Phase 2 data showed that its monoclonal antibody IFX-1 therapeutic tested in adults with Covid-19 induced pneumonia appears safe and has “promising” parameters.
The exploratory Phase 2 results demonstrated that inhibition with InflaRx’s (IFRX) IFX-1 appears safe in adults with severe COVID-19, according to the data published in The Lancet.
“FX-1 treatment had a positive, but not significant, effect on reversal of blood lymphocytopenia and reduction in lactate dehydrogenase concentrations – two parameters that have been reported as biomarkers for COVID-19 disease severity,” according to the data analysis.
IFX-1 is a first-in-class monoclonal anti-human complement factor C5a antibody, which blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. IFX-1 demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key “amplifier” of this response in pre-clinical studies.
According to the Lancet report, the expert committee, based on the review of available data, unanimously recommended continuing into Phase 3 and advised on changes to the study protocol.
However, it was also cautioned that ultimately, the Phase 2 part of the trial was exploratory in nature and efficacy of IFX-1 in patients with Covid-19 must be confirmed in a separate Phase 3 trial.
On Sept. 13, InflaRx announced the start of the global Phase 3 part of its Phase 2/3 trial with IFX-1 in severe Covid-19 induced pneumonia with the initiation of the first clinical site in the Netherlands. The Phase 3 trial will enroll approximately 360 early intubated, critically ill patients with Covid-19 induced pneumonia across sites in the US, EU, South America and other regions.
The primary endpoint will be 28-day all-cause mortality. Key secondary endpoints will include assessment of organ support and disease improvement. An interim analysis is planned after enrolment of 180 patients, with a potential for an early stop for efficacy or futility. In parallel, the German regulatory authority, the Paul-Ehrlich-Institut (PEI), has approved the Phase 3 clinical trial in Germany.
Shares in InflaRx have already advanced 15% so far this year, with the $9.83 average analyst price target implying a whopping 114% upside potential lies ahead.
Commenting on the data, Leerink Partners analyst Joseph Schwartz said that he is “encouraged” by the “strong signals” in the Phase 2 data and the Phase 3 trial design. For now, Schwartz is sticking to his Hold rating on the stock, while he is awaiting continued development in this indication.
The rest of the Street is sidelined on the stock. The Hold analyst consensus breaks down into 2 Holds, 1 Sell versus 1 Buy. (See IFRX stock analysis on TipRanks)
Inovio Dives 28% After FDA Halts COVID-19 Vaccine Trial
Bausch Scores FDA Approval For Preservative Free Allergy Eyedrop
Aquestive Plunges 37% As FDA Rejects Seizure Drug; Street Stays Bullish