Ra Pharmaceuticals, Inc. announced that it has begun dosing of the first patient in a phase II study of its investigational peptide C5 inhibitor, zilucoplan, for the treatment of immune-mediated necrotizing myopathy (IMNM) — a chronic, severe and debilitating autoimmune disease.
The phase II study will evaluate the safety, tolerability and efficacy of zilucoplan in patients with IMNM, who are positive for anti-3- HMGCR or anti-SRP autoantibodies. The study is expected to enroll about 24 patients for an eight-week treatment period.IMNM is an autoimmune neuromuscular disorder, which is characterized by skeletal muscle necrosis, severe proximal limb weakness and elevated creatine kinase (CK) levels. The primary endpoint of the study will be a change in creatine kinase (CK) levels from baseline to week eight. Top-line results from the study are expected in the second half of 2020. Once the study is complete, patients will have the option to enter an open-label, long-term extension study on zilucoplan.
Shares of the company have skyrocketed 188.7% year to date against the industry’s decline of 6.5%.
Other than IMNN, Ra Pharma is developing zilucoplan and zilucoplan extended release (XR) for generalized myasthenia gravis (gMG) andamyotrophic lateral sclerosis (ALS) and other tissue-based complement-mediated disorders with high unmet medical need.
In October, the company announced the initiation of dosing in a pivotal phase III study evaluating zilucoplan for gMG. The FDA has also granted Orphan Drug designation to zilucoplan for myasthenia gravis (MG).
Meanwhile, Ra Pharma is due to be acquired by UCB for $48 in cash per share at closing, which adds up to an approximate equity value of $2.5 billion. While the deal has been approved by the boards of both companies, approval from Ra Pharma shareholders is pending. The deal is expected to close by the end of the first quarter of 2020.
Zacks Rank & Stocks to Consider
Ra Pharmacurrently has a Zacks Rank #4 (Sell).
A few better-ranked stocks in the biotech sector are Alkermes Plc. (ALKS - Free Report) , Anika Therapeutics Inc. (ANIK - Free Report) and Innoviva Inc. (INVA - Free Report) , all sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Alkermes’ earnings per share estimates have increased from 36 cents to 52 cents for 2019 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 236.80%, on average.
Anika’s earnings per share estimates have increased from $1.75 to $2.03 for 2019 and from $1.38 to $1.62 for 2020 in the past 60 days. The company delivered a positive earnings surprise in the trailing four quarters by 53.31%, on average.
Innoviva’s earnings per share estimates have increased from $1.59 to $2.03 for 2019 and from $1.22 to $1.34 for 2020 in the past 60 days.
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