Regeneron, Sanofi Report Positive Dupilumab Phase III Data

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) and Sanofi (NYSE:SNY) announced encouraging long-term data from a phase III (LIBERTY AD CHRONOS) study evaluating dupilumab with topical corticosteroids (TCS) versus TCS alone in inadequately controlled moderate-to-severe atopic dermatitis (AD) patients.

Results demonstrated that dupilumab with TCS significantly improved measures of overall disease severity at 16 and 52 weeks when compared to placebo with TCS, thereby meeting both primary and key secondary endpoints, respectively.

Primary endpoint results at week 16 showed that 39% of patients who received dupilumab (either 300 mg weekly or 300 mg every two weeks) with TCS witnessed clearing or near-clearing of skin lesions compared to 12% of patients in the placebo with TCS arm. Additionally, 64% of patients on dupilumab 300 mg weekly with TCS and 69% of patients on dupilumab 300 mg every two weeks with TCS achieved EASI-75 compared to 23% of patients receiving placebo with TCS. Moreover, it was found that patients in the dupilumab with TCS groups were less likely to discontinue treatment compared to patients in the placebo with TCS group.

As per the companies’ press release, a regulatory application in the U.S., which is planned for the third quarter of 2016, will include these data in addition to previously reported data from phase III studies.

We note that positive top-line data from two phase III studies – LIBERTY AD SOLO 1 and SOLO 2 – evaluating dupilumab as a monotherapy in adults with inadequately controlled moderate-to-severe AD were announced in Apr 2016.

Considering that there are roughly 1.6 million patients in the U.S. who have been diagnosed with moderate-to-severe AD, and are currently being treated but are still living with inadequately controlled disease, its approval would be a huge boost for the patient population and both companies.

We note that dupilumab enjoys Breakthrough Therapy status in the U.S. for the treatment of AD. This designation should expedite the development and review process of the candidate.

Apart from AD, dupilumab is also being evaluated for additional inflammatory indications including asthma and nasal polyposis.

Currently, both Regeneron and Sanofi are Zacks Rank #3 (Hold) stocks. Bristol-Myers Squibb Company (NYSE:BMY) and ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) are a couple of better-ranked stocks in the health care sector, each sporting a Zacks Rank #1 (Strong Buy).