Novartis' Asthma Candidate Fails In LUSTER Phase III Studies

Novartis AG (NYSE:NVS) announced top-line results from its pivotal, global, phase III LUSTER-1 and LUSTER-2 studies evaluating the efficacy and safety of the investigational oral, once-daily, DP₂ receptor antagonist, fevipiprant (QAW039). The studies aimed to determine the efficacy, safety and tolerability of the candidate in addition to the current standard-of-care in severe asthma patients. The studies included 894 (LUSTER-1) and 877 (LUSTER-2) patients aged above or equal to 12 years, all of whom suffer from inadequately controlled moderate-severe asthma, receiving Global Initiative for Asthma (GINA) Steps 4 and 5 standard-of-care (SoC) asthma therapy, inhaling mid-to-high dose corticosteroids (ICS) and at least one additional controller.

The analysis of the studies showed that the candidate did not meet the clinically relevant threshold for a reduction in the rate of moderate-to-severe exacerbation compared to placebo over a 52-week treatment period for either of the doses (150mg / 450 mg).

Fevipiprant was generally well tolerated, with treatment-emergent adverse events generally balanced across groups and comparable to placebo. However, the totality of these results does not support further development of fevipiprant in asthma.

Novartis’ stock has increased 8.5% year to date compared with the industry's 9.9% growth.

Novartis continues to invest into respiratory medicines. In October, the company announced mixed results from the phase III IRIDIUM study on investigational, once-daily, inhaled QVM149 (indacaterol acetate, glycopyrronium bromide and mometasone furoate or IND/GLY/MF).

QVM149 demonstrated statistically significant improvement in lung function as compared to QMF149 (indacaterol acetate and mometasone furoate or IND/MF), thereby meeting the primary endpoint in asthma patients, whose disease was uncontrolled on treatment with a long-acting beta agonist/inhaled corticosteroid (LABA/ICS).

However, the key secondary endpoint — improvement in the Asthma Control Questionnaire (ACQ-7) score for IND/GLY/MF versus IND/MF — was not met.

We note that IRIDIUM is the largest study in the phase III PLATINUM clinical development program, which evaluates the inhaled combinations — QVM149 and QMF149.

The company’s Xolair is already approved for the treatment of moderate-to-severe, or severe, persistent allergic asthma. The company has a collaboration agreement with Roche (OTC:RHHBY) for the same in the United States.

Zacks Rank & Stocks to Consider

Novartis currently carries a Zacks Rank #3 (Hold).

A few better-ranked stocks in the large-cap pharma sector are GlaxoSmithKline plc. (NYSE:GSK) and Merck & Co. Inc. (NYSE:MRK) , both carrying a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

GlaxoSmithKline’s earnings per share estimates have increased from $3.00 to $3.17 for 2019 and from $2.99 to $3.10 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 17.23%, on average.

Merck’s earnings per share estimates have increased from $4.90 to $5.15 for 2019 and from $5.35 to $5.49 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 12.51%, on average.

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