Sanofi (SNY) and partner Regeneron Pharmaceuticals, Inc. (REGN) announced that the first patients have been dosed in a phase III study, LIBERTY AD CHRONOS, on pipeline candidate dupilumab.

Dupilumab works by blocking IL-4 and IL-13 signalling in adults and is being evaluated for the potential treatment of moderate-to-severe atopic dermatitis (AD.TO).

We note that LIBERTY AD CHRONOS is the first study (n=700) of the five trials in the phase III program on dupilumab. The primary endpoint of the randomized, double-blind, placebo-controlled study is to evaluate the efficacy of dupilumab in adults suffering from moderate-to-severe AD when administered concomitantly with topical corticosteroids through 16 weeks. The secondary endpoint of the study is to evaluate the long-term safety and efficacy of dupilumab up to 52 weeks.

Dupilumab was developed using Regeneron's pioneering VelocImmune technology. Apart from being evaluated for the treatment of AD, dupilumab is being evaluated for the potential treatment of asthma and chronic sinusitis with nasal polyposis.

Last month, Regeneron and Sanofi announced that dupilumab has met all primary and secondary endpoints in a randomized, double-blind, placebo-controlled phase IIa proof-of-concept study. The study evaluated dupilumab in patients (50% underwent prior surgery) suffering from moderate-to-severe chronic sinusitis with nasal polyps who did not respond to intranasal corticosteroids. Of the total number of patients, 58% also suffered from asthma.

The primary endpoint of the study was measured by the improvement in the size of nasal polyps. Dupilumab showed a statistically significant improvement in the size of nasal polyps. Moreover, dupilumab significantly improved objective measures of sinusitis by CT scan, nasal air flow and patient-reported symptoms including sense of smell, congestion, postnasal drip, runny nose and sleep disturbance.

We are encouraged by the pipeline progress and expect investor focus on further updates from both the companies.

Sanofi currently carries a Zacks Rank #4 (Sell) while Regeneron is a Zacks Rank #1 (Strong Buy). Investors may consider stocks like Allergan Inc. (AGN) and Shire plc (SHPG) in the broader health care sector. Both carry a Zacks Rank #2 (Buy).

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