About Epalex
Epalex is devoted to the development of novel breakthrough treatments to improve the quality of life for people with migraine and epilepsy. The company is advancing several unique products that take advantage of Epalex's deep expertise in neuropharmacology and medicinal chemistry. Epalex's lead therapeutics are chemically and mechanistically differentiated, and are intended to be best-in-class in their therapeutic areas. One product (EP-102) is a first-in-class oral treatment for acute migraine with a novel mechanism of action that is intended to address the market for refractory migraine. The second product (EP-103) is designed to provide a more effective, better patient and caregiver accepted, treatment for acute repetitive seizures. Epalex is also developing transformational products for seizure prophylaxis in patients suffering from primary generalized epilepsies.
About Migraine
Migraine is an episodic neurological disorder characterized by headache that is often throbbing in character and usually worse on one side of the head. The pain is often severe enough to hamper daily activities and may last from four hours to three days if untreated. Migraine headaches are often associated with sensitivity to light or sound. Many people have nausea, vomiting, or visual disturbances. The attacks can be disabling, forcing people to miss work or other activities. More than one in 10 Americans, including one in 6 women, have migraines. Foods, stress, and hormones can be migraine triggers.
About Acute Repetitive Seizures
A repetitive seizure is a seizure that follows soon after another seizure ends. Acute repetitive seizures (ARS) is a serious condition that occurs in patients with drug refractory (pharmacoresistant) epilepsy. In ARS, a series of seizures grouped consecutively occurs, typically with short (or shorter than normal) interictal periods, often hours or even minutes. ARS is a feature of diverse epilepsies with differing underlying mechanisms or etiologies. The frequency of seizures during an ARS episode depends on the underlying epilepsy and specific patient characteristics. For example, a woman with mesial temporal lobe epilepsy has ARS when she experiences three catamenial seizures within two premenstrual days. As another example, a man with juvenile myoclonic epilepsy has ARS when he experiences 90 min of early morning repetitive myoclonic jerks. More generally, ARS is thought of as a change in frequency or severity of seizures. ARS is also called cluster seizures, seizure clusters, serial seizures, seizure flurries, breakthrough seizures, or prolonged seizures.
Unmet Clinical Need in ARS
ARS is a serious medical condition that required immediate treatment. Complications and negative impacts of of ARS are post-ictal psychosis; injury from falls and burns; and negative social and economic impact from frequent emergency room visits, hospitalizations, and missed school or work days. In addition, ARS is believed to be a precursor to status epilepticus, which may lead to permanent neurological injury and death.
Diazepam rectal gel (Diastat® AcuDial™) is the only FDA-approved treatment for ARS in U.S. The rectal route of administration is poorly accepted accepted by patients and caregivers. Diazepam rectal gel provides incomplete efficacy: ~30% of ARS patients treated with Diastat® had recurrent seizure within 4 h. In addition, it is believed that patients experiencing ARS develop tachyphylaxis to benzodiazepines such as diazepam. Side effects of diazepam rectal gel range from prolonged sedation to respiratory arrest. Intranasal benzodiazepines formulations improve only on the rectal route of administration limitation.
Diazepam rectal gel (Diastat® AcuDial™) is the only FDA-approved treatment for ARS in U.S. The rectal route of administration is poorly accepted accepted by patients and caregivers. Diazepam rectal gel provides incomplete efficacy: ~30% of ARS patients treated with Diastat® had recurrent seizure within 4 h. In addition, it is believed that patients experiencing ARS develop tachyphylaxis to benzodiazepines such as diazepam. Side effects of diazepam rectal gel range from prolonged sedation to respiratory arrest. Intranasal benzodiazepines formulations improve only on the rectal route of administration limitation.
Program Funding
The research programs of Epalex have been supported by the University of California, Davis; the Epilepsy Therapy Project; the Epilepsy Foundation of America; and the National Institutes of Health through the National Center for Advancing Translational Sciences.
An Epalex lead program is the subject of one of the original BrIDGs (Bridging Interventional Development Gaps) awards of NIH's National Center for Advancing Translational Sciences (NCATS), representing a partnership between Epalex and UC Davis. Further information is available from NCATS.
