Acorda Therapeutics Inc (NASDAQ:ACOR) investors are having a rough morning, after the drug maker announced that it plans to discontinue the development of Ampyra for post-stroke walking deficits (PSWD) due to inadequate efficacy observed from the unblinded BID study results.
In reaction, Acorda shares are falling nearly 10% in pre-market trading Monday.
“We are disappointed by this outcome. The study indicated there was activity related to walking in people with PSWD, as suggested by the prior Phase 2 study, but overall this was not sufficiently clinically meaningful. I want to express our gratitude to the study participants, their care partners and clinicians, who gave their time and commitment to this research,” said Ron Cohen, M.D., President and CEO of Acorda. “This outcome underscores the risks that companies in the biopharmaceutical industry must take in order to develop innovative medicines. Over the past three years, we have successfully diversified our pipeline portfolio to account for this risk. We plan to focus R&D resources on developing our promising late-stage Parkinson’s disease therapies, CVT-301 and tozadenant, as well as advancing our earlier stage assets, CVT-427 in migraine, SYN120 in Parkinson’s disease dementia, and rHIgM22 in MS.”
As part of the PSWD development program, a multi-dose pharmacokinetic (PK) study confirmed the Company has developed a potentially viable once-daily (QD) formulation of dalfampridine.
MILESTONE Efficacy and Safety Findings
The Company elected to stop enrollment and to conduct an unblinded analysis of the MILESTONE trial after reaching enrollment of 377 participants. This analysis included 368 participants who received either 10 mg or 7.5 mg of dalfampridine twice daily (BID) or placebo. The primary outcome measure of the study was the proportion of participants who showed at least a 20% improvement on the Two Minute Walk Test (2MinWT) at Week 12 as compared to baseline. The 2MinWT measures the distance a subject can walk in 2 minutes, and is a validated scale used to assess walking capacity.
The study found that 23 of 121 (19.0%) participants receiving 10 mg of dalfampridine BID and 17 of 121 (14.0%) participants receiving 7.5 mg of dalfampridine BID showed at least a 20% improvement on the 2MinWT, compared to 17 of 126 (13.5%) participants receiving placebo.
In this study, dalfampridine was well tolerated in the post-stroke population. The safety profile overall was similar to that observed in multiple sclerosis clinical trials and post-marketing surveillance. The most common adverse events (≥ 5%) reported in this study were: falls (10 mg: 10.7%, 7.5 mg: 9.5%, placebo: 5.6%), urinary tract infections (10 mg: 9.0%, 7.5 mg: 6.3%, placebo: 2.4%), dizziness (10 mg: 3.3%, 7.5 mg: 7.9%, placebo: 2.4%) and fatigue (10mg: 2.5%, 7.5 mg: 3.2%, placebo: 6.3%). There were no seizures reported in the dalfampridine 10 mg group. There were 2 seizures reported in the 7.5 mg group and 3 reported in the placebo group.
Additional data from the MILESTONE study will be presented at a future medical meeting. (Original Source)
On the ratings front, Acorda has been the subject of a number of recent research reports. In a report issued on October 27, Cowen analyst Phil Nadeau reiterated a Buy rating on ACOR, with a price target of $60, which implies an upside of 182% from current levels. Separately, on October 4, Leerink Swann’s Paul Matteis reiterated a Hold rating on the stock and has a price target of $25.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Phil Nadeau and Paul Matteis have a yearly average return of 3.1% and 10.9% respectively. Nadeau has a success rate of 51% and is ranked #996 out of 4227 analysts, while Matteis has a success rate of 63% and is ranked #328.
Acorda Therapeutics, Inc. develops and markets therapeutic products for nervous system disorders. The company’s two main products are Ampyra and Zanaflex Capsules. The Ampyra is an oral drug, which treats to improve walking in patients with multiple sclerosis and Zanaflex Capsules, which is a short acting drug for the management of spasticity, a symptom of many central nervous system disorders, including multiple sclerosis and spinal cord injury.