Profile: Acorda Therapeutics Inc (ACOR.O)
5 Oct 2015
Acorda Therapeutics, Inc. (Acorda), incorporated on March 17, 1995, is a biopharmaceutical company. The Company is engaged in the identification, development and commercialization of therapies that restore neurological function and treat patients with neurological disorders. The Company’s markets three United States Food and Drug Administration (FDA)-approved therapies, including Ampyra (dalfampridine) Extended Release Tablets, 10milligrams, a treatment to improve walking in patients with multiple sclerosis (MS). It also markets Zanaflex Capsules and tablets, FDA-approved as short-acting drugs for the management of spasticity, and Qutenza, an FDA-approved dermal patch for the management of neuropathic pain associated with post-herpetic neuralgia, also known as post-shingles pain. The Company is also developing a number of clinical and preclinical stage therapies for the treatment of a range of disorders, including chronic post-stroke walking deficits (PSWD), Parkinson’s disease, epilepsy, heart failure, MS, and spinal cord injury.
The Company’s product portfolio consists of commercial products and research and development programs. Its commercial products include Ampyra, Fampyra, Zanaflex Capsules and an authorized generic version of the capsules, Zanaflex tablets and Qutenza. Its research and development programs include CVT-301, Dalfampridine, Plumiaz, Neuregulin Program, Remyelinating Antibodies Program, CVT-427 and Chondroitinase Program.
CVT-301 and ARCUS Technology
CVT-301 is a Phase II-ready inhaled formulation of levodopa, or L-dopa, for the treatment of OFF episodes in Parkinson’s disease. CVT-301 is based on the proprietary ARCUS technology platform. The ARCUS technology is a dry-powder pulmonary delivery system that has potential applications in multiple disease areas. The Company has enrolled the first patient in a Phase III study of CVT-301 for the treatment of OFF episodes in Parkinson’s disease. The Company’s CVT-301 development includes this Phase III efficacy trial and safety extension, and two pharmacokinetic studies in specific sub-populations.
Ampyra/Dalfampridine Development Programs
The Company is studying the use of dalfampridine in patients who experience chronic post-stroke deficits. The Company has conducted a Phase II proof-of-concept trial of dalfampridine-ER (extended release) in people with post-stroke deficits. The primary goals of the proof-of-concept trial were to assess safety and tolerability, as well as to explore various efficacy measures. In the study, treatment with dalfampridine improved walking, as measured by the Timed 25-Foot Walk test (T25FW). The safety findings in this study were consistent with previous clinical trials and post-marketing experience of dalfampridine-ER (extended release) in MS. The Company has also commenced a Phase III clinical trial evaluating the use of dalfampridine administered twice daily (BID) to improve walking in people who are suffering from chronic post-stroke walking deficits after experiencing an ischemic stroke. The BID formulation was used in the proof of concept study, described above. The Company has been exploring a once-daily (QD) formulation of dalfampridine for use in the chronic post-stroke clinical program.
Plumiaz is a nasal spray formulation of diazepam. The Company is developing Plumiaz as a treatment for the management of selected, refractory patients with epilepsy, on stable regimens of antiepileptic drugs, or AEDs, who experience intermittent bouts of increased seizure activity, also known as seizure clusters or acute repetitive seizures (ARS).
Cimaglermin alfa (previously GGF2)/Neuregulins
Cimaglermin alfa, which was previously referred to as GGF2, is a member of the neuregulin growth factor family, and has been shown to promote recovery after neurological injury, as well as enhance heart function in animal models of heart failure. The Company has completed a Phase I clinical trial of cimaglerminin heart failure patients. This was a dose-escalating trial designed to test the maximum tolerated single dose, with follow-up assessments at one, three, and six months. Data from its Phase I study showed a dose-related improvement in ejection fraction in addition to safety findings. A dose-limiting toxicity was also identified in the highest planned dose cohort, specifically acute liver injury meeting Hy’s Law for drug induced hepatotoxicity. The Company is also conducting a Phase Ib single-infusion trial in people with heart failure is assessing tolerability of three dose levels of cimaglermin, and also includes assessment of drug-drug interactions and several exploratory measures of efficacy.
Remyelinating Antibodies Program
The Company remyelinating antibodies program is based on its research collaboration with Mayo Foundation for Medical Education and Research, or Mayo Clinic. Studies have demonstrated the ability of this family of antibodies to stimulate repair of the myelin sheath in three different animal models of MS. These antibodies were found to react with molecules on the surface of the cells that make the myelin sheath and stimulate them, leading to increased remyelination activity. Some antibodies within this portfolio also stimulate the growth of neurons and may have applications beyond demyelinating disorders. First identified in mice, similar remyelinating antibodies were subsequently identified in human blood samples by Mayo Clinic and the Company has produced a recombinant human antibody (rHIgM22). The Company is developing the lead antibody (rHIgM22) as a potential therapeutic for MS. The Company has initiated a Phase I clinical trial of rHIgM22 to assess the safety and tolerability of rHIgM22 in patients with MS. The study also includes several exploratory clinical, imaging and biomarker measures. The trial, which followed participants for up to six months after receiving a single dose of rHIgM22, found no dose-limiting toxicities at any of the five dose levels studied.
The Chondroitinase program is focused on developing chondroitinase as a therapeutic to break down the matrix of scar tissue that develops as a result of an injury to the central nervous system (CNS). In the pre-clinical study the Company tested the ability of the molecule, Chondroitinase ABC-I, to improve function in an animal model of spinal cord injury (SCI). In these studies, rats that sustained an SCI were treated with either chondroitinase or an ineffective enzyme control and evaluated over 10 weeks of recovery. Animals treated with chondroitinase showed improvements both in motor function of the limbs and in bladder function, compared to those treated with the control enzyme. The Company has also produced and tested a recombinant version of naturally occurring Chondroitinase ABC-I in these same animal models. The Company is conducting a research program to develop second generation approaches to overcoming the proteoglycan matrix.
The Company competes with Biogen Idec, Schering AG, Teva Pharmaceutical Industries, Ltd., Merck Serono, Elan, Novartis AG, BioMarin Pharmaceutical Inc., EUSA Pharma, Catalyst Pharmaceuticals, Impax Laboraties, Impax Depomed Inc., NeuroDerm Ltd., Abbvie Inc., Alexza Pharmaceuticals, Inc., MannKind Corporation, Pulmatrix, Inc., Vectura Group plc, Allergan, Inc., GlaxoSmithKline plc and Meridian Medical Technologies.
Acorda Therapeutics Inc
420 Saw Mill River Rd
ARDSLEY NY 10502-2605