Regeneron, SNY Report Mixed Results From Late-Stage COPD Studies

Regeneron Pharmaceuticals, Inc. REGN and partner Sanofi SNY announced mixed results from two late-stage studies, AERIFY-1 and AERIFY-2, on itepekimab for the treatment of chronic obstructive pulmonary disease (COPD).

The candidate is being jointly developed by Regeneron and Sanofi. It is currently in clinical development programs for chronic rhinosinusitis with nasal polyps (phase III), non-cystic fibrosis bronchiectasis (phase II) and chronic rhinosinusitis without nasal polyps (phase II).

Year to date, REGN’s shares have lost 14.8% compared with the industry’s 2.8% decline.

More on REGN/SNY’s Itepekimab

AERIFY-1 and AERIFY-2 are randomized, phase III, double-blind, placebo-controlled trials that evaluated the efficacy and safety of itepekimab in 1,127 (AERIFY-1) and 953 (AERIFY-2) adults aged 40-85 years who were former smokers with moderate-to-severe COPD.

The patients were randomized to receive itepekimab every two weeks, every four weeks, or placebo, which was added to inhaled triple or double standard-of-care therapy. The primary endpoint for AERIFY-1 and AERIFY-2 was the reduction in the annualized rate of acute moderate or severe COPD exacerbations with itepekimab treatment.

AERIFY-1 met the primary endpoint of significantly reducing moderate or severe acute exacerbations by 27% compared to placebo at week 52, which was a clinically meaningful benefit.

However, AERIFY-2 did not meet the same primary endpoint, although a benefit was seen earlier in the study.

Both companies are currently reviewing the data and plan to discuss the next steps with regulatory authorities.

The AERIFY program includes two additional ongoing trials: AERIFY-3, a phase II mechanistic study assessing the impact of itepekimab on airway inflammation in patients with COPD, and AERIFY-4, a phase III study assessing the long-term safety of itepekimab in patients with COPD.

REGN Looks to Broaden Portfolio

Regeneron's performance in the first quarter was dismal. The plunge in Eylea sales adversely impacted the top line.

Eylea sales have been under pressure for some time now due to competition from Roche’s RHHBY Vabysmo. We note that Vabysmo's uptake has been outstanding. Roche designed Vabysmo to block pathways involving Ang-2 and VEGF-A.

Regeneron has a tough road ahead, as it will take a long time for Eylea HD to contribute significantly to the top line.

Apart from Eylea, profits from the sales of asthma drug Dupixent are a primary growth driver for REGN. Regeneron has a collaboration agreement with Sanofi for Dupixent.

Dupixent sales maintain momentum, driven by continued strong prescription trends in atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, eosinophilic esophagitis and prurigo nodularis. The recent label expansion of the drug in the COPD indication has boosted sales.

Hence, the successful development and commercialization of itepekimab for COPD will broaden REGN’s portfolio.

The company is also looking to ramp up with the oncology portfolio. Last month, the European Commission granted conditional marketing approval to linvoseltamab under the brand name Lynozyfic to treat adults suffering from relapsed/refractory (R/R) multiple myeloma (MM).  

The FDA has accepted for review the resubmission of the BLA for linvoseltamab with a target action date of July 10, 2025.

REGN’s Zacks Rank

REGN currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

 

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This article originally published on Zacks Investment Research (zacks.com).

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