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IFRX

InflaRx

$41.96

-0.61 (-1.43%)

08:12
05/14/19
05/14
08:12
05/14/19
08:12

InflaRx commences second Phase 2 trial of IFX-1

InflaRx announced the treatment of the first patient in IXchange, a Phase 2 study with IFX-1 in patients with ANCA-associated vasculitis, or AAV. AAV is a rare and life-threatening autoimmune disease in which activation of the complement system, and specifically generation of C5a, is believed to play a key role in the neutrophil-driven vessel inflammation that defines the disease. The disease affects approximately 40,000 and 75,000 patients in the United States and Europe, respectively. The main objective of this randomized, double-blind, placebo-controlled Phase II study is to evaluate the efficacy and safety of IFX-1 in patients with moderate to severe AAV. The trial is planned to enroll approximately 80 patients at about 60 sites in up to 12 European countries and Russia. The study will be conducted in two parts. In Part 1, patients are being randomized to receive either IFX-1 plus a reduced dose of glucocorticoids, or placebo plus a standard dose of glucocorticoids. Patients in both arms will receive the standard of care dosing of immunosuppressive therapy. Prior to starting Part 2 of the study, an independent data monitoring committee will evaluate the efficacy and safety results from Part 1 and recommend if the study should continue. Part 2 will evaluate if treatment with IFX-1 alone is as effective as IFX-1 in combination with glucocorticoids. Thus, in Part 2 patients will be randomized to receive IFX-1 plus placebo glucocorticoids versus placebo plus a standard dose of glucocorticoids. Patients in both arms will receive standard of care immunosuppressive therapy. The primary endpoint of the study is a 50% reduction in Birmingham Vasculitis Activity Score, or BVAS, at week 16, an endpoint that has been used in the previous AAV studies. Secondary efficacy endpoints being analyzed include clinical remission, evaluation of the Vasculitis Damage Index, reduction of glucocorticoid toxicity, several relevant biomarkers like glomerular filtration rate and patient reported outcomes.

IFRX InflaRx
$41.96

-0.61 (-1.43%)

01/28/19
BARD
01/28/19
INITIATION
Target $62
BARD
Outperform
InflaRx initiated with an Outperform at Baird
Baird initiated InflaRX with an Outperform and $62 price target.
02/05/19
JPMS
02/05/19
NO CHANGE
Target $65
JPMS
Overweight
InflaRx price target raised to $65 from $42 at JPMorgan
JPMorgan analyst Anupam Rama raised his price target for InflaRx to $65 from $42 ahead of the Phase 2b Shine study of IFX-1 In hidradenitis suppurativa. The data readout, expected in Q2, "largely remains an under the radar catalyst," Rama tells investors in a research note. The analyst continues to believe the Shine study has a high probability of success and the potential to be a "transformational catalyst" for InflaRx shares. Rama sees share upside potential from the readout ranging from 60% to 150%-plus versus downside in the 40%-55% range. He reiterates InflaRx as a top pick for the first half of 2019 and keeps an Overweight rating on the name.
02/22/19
GUGG
02/22/19
INITIATION
Target $65
GUGG
Buy
InflaRx initiated with a Buy at Guggenheim
Guggenheim analyst Yatin Suneja initiated InflaRx initiated with a Buy rating and $65 price target, citing his view that early data from lead asset IFX-1 indicate that it could be superior to the current standard of care, Humira, in its lead indication of hidradenitis suppurativa.
04/24/19
BMOC
04/24/19
NO CHANGE
Target $64
BMOC
Outperform
InflaRx price target raised to $64 from $45 at BMO Capital
BMO Capital analyst Matthew Luchini raised his price target on InflaRx to $64, citing his discussions with physicians that revealed "greater similarities in treatment approach and clinical outcomes in hidradenitis suppurativa Hurley Stage II and III patients than previously appreciated." Luchini is keeping his Outperform rating on the shares while also raising his peak sales estimate to $1.17B from $940M, stating that the "similarities suggest a potentially larger opportunity in Stage II than previously assumed."

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