Acorda Therapeutics, Inc. ACOR has decided to discontinue development of Ampyra (dalfampridine) for an expanded indication of post-stroke walking difficulties (PSWD). The company’s shares fell 4.2% on the news.
The decision was based on an interim analysis of a clinical study, MILESTONE, which failed to show sufficient efficacy to support further development of the drug. Although the drug demonstrated activity related to walking in people with PSWD, as suggested by a prior phase II study, this was not clinically meaningful enough.
The unblinded MILESTONE trial enrolled 368 participants who received either 10 mg or 7.5 mg of dalfampridine twice daily (BID) or placebo. It was found that 19% of the participants receiving 10 mg of dalfampridine BID and 14% of those on 7.5 mg of dalfampridine BID showed at least a 20% improvement on the Two Minute Walk Test (2MinWT), compared to 13.5% treated with placebo. However, the company said the result was not statistically significant enough to support further development of the candidate. Meanwhile, the company has released positive data from a multi-dose PK study of a once-daily formulation was released.
Note that Ampyra is already approved for the improving walking in multiple sclerosis (MS) patients. The drug is manufactured globally by Alkermes plc ALKS, based on a supply agreement with Acorda. Acorda also has a licensing agreement with Biogen Inc. BIIB for the development and commercialization of Ampyra in ex-U.S. markets under the trade name of Fampyra.
According to Acorda, Ampyra is the first and only approved drug for the improvement of walking in MS patients. The company is planning to focus its R&D resources on developing its promising late-stage Parkinson’s disease therapies which includes CVT-301 and tozadenant. It is also advancing its early-stage assets – CVT-427 in migraine, SYN120 in dementia associated with Parkinson’s disease and rHIgM22 in MS.
Zacks Rank & Key Picks
Acorda currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is Cambrex Corporation CBM, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Cambrex’s earnings estimates increased from $2.46 to $2.55 for 2016 and from $2.91 to $3.06 for 2017 over the last 60 days. The company posted a positive earnings surprise in three of the four trailing quarters with an average beat of 19.78%. Its share price has increased 5.1% year to date.
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