UCB backs epilepsy-focused digital heath startup Nile AI

Belgian drugmaker UCB has been steadily building its digital health expertise for several years, and that includes nurturing new projects. One of those is now being launched as a new company – Nile AI – that aims to improve the care of people with epilepsy.

UCB is bankrolling Los Angeles-based Nile with €25 million (around $29 million) in startup cash and will be a majority shareholder, with a presence on the company’s board as well as options on acquiring “data and insights” from its platform.

Nile is being formed to develop a digital health platform – consisting of a patient app that links to a portal for healthcare professionals – that can use data from patients’ past epileptic seizures to try to predict future attacks.

The patient app connects individuals with their care team, and provides information about their treatment and progress, while the portal shows the status of patients, maintains support between consultations, and allows data-driven decisions on treatment and care, according to UCB.

The digital tools are being piloted at Massachusetts General Hospital and Michigan State University Healthcare, and the aim is to have it ready for a commercial launch before the end of this year.

“We know that patients suffering from epilepsy struggle with the unpredictable nature of their lives,” said Dr Leo Petrossian, Nile AI’s CEO.

“Every single day they awake uncertain of what they can expect. At Nile, we believe that all of the data to predict the path of an epilepsy patient exists, though it is fragmented and disconnected.”

Nile’s software operates as a care management system, and cam be used to address this uncertainty, he continued, with the ultimate goal of shortening the time it takes for people with epilepsy to be on the best care available.

It’s a mission that dovetails with UCB’s position as a well-established player in the epilepsy category. Medicines like Vimpat (lacosamide), Keppra (levetiracetam), Briviact (brivaracetam) and recent launch Nayzilam (midazolam) nasal spray collectively make upwards of €2.3 billion a year and account for almost half of its net sales.

UCB added to its range last June with the $270 million acquisition of Engage Therapeutics and its Staccato Alprazolam product for the rapid termination of seizures.

“UCB has a deep understanding of epilepsy and the challenges that people living with the disease face every day, including how patients communicate with their healthcare providers,” said the Belgian firm’s head of neurology Charl Van Zyl.

“We think Nile’s platform can provide valuable insights and foster a better care management experience for people living with epilepsy.”

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UCB Launches Nile AI as a Digital Health Company to Transform the Course of Epilepsy

Shots:

  • UCB invested $29.3M in Nile and as majority shareholder, will be the Board of Directors of Nile with future opportunities to acquire insights and data from Nile’s platform
  • Nile is developing a digital epilepsy care management platform and bringing together data to make the epilepsy journey predictable. The platform consists of patient app and HCP portal & is anticipated to be commercially available in 2021
  • Nile’s platform will serve as a digital extension of the HCPs with an aim of shortening the path to optimal treatment

Click here ­to­ read full press release/ article | Ref: UCB | Image: Pharmaphorum

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21 of the most common questions about Epilepsy

The term Epilepsy isn’t new. It’s been present in the air for centuries now, however, only a few are aware that it is one of the most common neurological diseases in the world. It affects around 50 million people worldwide. However, public awareness regarding Epilepsy is quite less and it can result in the rise of false notions and stigma. Some of the most asked questions around Epilepsy are as follows:

  1. What is epilepsy?

Epilepsy is a disorder of the central nervous system (neurological). It causes of unusual or abnormal brain activity characterized by seizures or periods of unusual behavior, sensations, and sometimes loss of awareness. 

Epilepsy can develop in any person and at any age. However, it is more common in young children and older people. It was also observed that men are more at risk to develop epilepsy than women. About 1 in 100 people will have an unprovoked seizure in their lifetime.

  1. What causes Epilepsy?

The causes of Epilepsy vary from person to person. Different conditions that affect the normal functioning of the brain can lead to Epilepsy. However, in most cases, the reason behind Epilepsy remains unclear. This type of epilepsy is called cryptogenic or idiopathic. Some known causes include:

  • Stroke.
  • Brain tumor.
  • Severe Head Injury.
  • Lack/ loss of oxygen to the brain (especially during birth).
  • Brain infection from parasites (malaria, neurocysticercosis), viruses (influenza, dengue, Zika), and bacteria.
  • Drug or alcohol abuse.
  • Some genetic disorders (such as Down syndrome).
  • Other neurologic diseases (such as Alzheimer’s disease).
  1. What are the seizures?

A seizure is a sudden, uncontrolled, abnormal electrical disturbance or activity in the brain. It might or might not go unnoticed, however, in serious cases, it results in unconsciousness and convulsions accompanied by sudden uncontrollable jerks in the body.

Seizures can lead to changes in behavior, feelings, body movements and consciousness. Episodes of two or more seizures confirm Epilepsy. 

What are the different types of Seizures? 

Seizures are broadly classified into two groups. 

Generalized seizures that affect all areas of the brain. It is further bifurcated into: 

  • Absence seizures, also sometimes referred to as petit mal seizures, can cause rapid blinking or a few seconds of staring into space. It can also involve lip-smacking and cause a brief loss of awareness. 
  • Tonic-clonic seizures, also called grand mal seizures, can make a person cry out, lose consciousness, lose balance, experience muscle jerks or spasms and get tired. It causes stiffness in arms and legs. 
  • Atonic seizures also known as drop seizures, may lead to sudden collapsing or falling down of the body due to loss in muscle movements. 
  • Clonic seizures are associated with repeated or rhythmic, jerking movements of the muscles usually of the neck, face and arms. 
  • Febrile seizures are convulsions faced by a child from a high fever caused by an infection. They only last a few minutes but are often harmless.

Focal seizures are the seizures that are a result of abnormalities in just one area of the brain. These seizures are also called partial seizures. 

  • Simple focal seizures affect a small part of the brain. These seizures can cause twitching or a change in sensation, such as a strange taste or smell. 
  • Complex focal seizures make a person with epilepsy confused, dazed or lose consciousness. The person will be unable to respond to questions or direction for up to a few minutes.
  1. How common are seizures?

According to the WHO, up to 10% of the total global population will experience one seizure during their lifetime. Seizures can happen anytime and so suddenly that it even gets undetected or unnoticed. Less than 1 in 10 people who have a seizure get epilepsy.

  1. Why do people get epilepsy?

Factors such as health conditions, age, and race may act as triggers in developing epilepsy and seizures. Brain tumour or strokes can cause seizures. Stroke is a leading cause of epilepsy in adults older than age 35. It has been also observed that infectious diseases such as meningitis, AIDS and viral encephalitis can also cause seizures.

  1. Can Seizures kill you? 

Seizures can be fatal. Among people with uncontrolled epilepsy, sudden expected death in epilepsy (SUDEP) is responsible for the death of 1 in 1,000 people. 

  1. In what ways can a seizure kill you?

During a seizure, a person can face issues with breathing that can become fatal. An obstructed airway due to convulsion seizure can lead to suffocation. Abnormal heart rhythm during a seizure can also become fatal. However, the exact cause still remains in the dark and further research is underway. 

  1. How do seizures cause brain damage?

Epileptic seizures can cause severe damages to brain cells. There exists indirect evidence of uncontrolled epilepsies causing progressive brain injury. (Tasch E., et al). A study led by Thompson and Duncan demonstrated a particularly strong relationship between cognitive decline and the frequency of generalized tonic-clonic seizure. It also noted that frequent complex partial seizures were also associated with worsening scores in tests of verbal learning, delayed recall, and semantic fluency, suggesting site-specific cerebral effects of seizures or of epileptogenic pathology.

  1. Why do people froth in seizures?

Usually, during a seizure, the mouth is shut closed. This leads to stimulation of salivary glands thus producing spit in excess. When the mouth opens, it comes out in the form of drool or forty salivate. 

  1. Can Epilepsy cause personality changes?

Epilepsy can be associated with changes in cognition, personality, and other behavioral aspects. Changes in emotional state can also be observed. The most important aspect of behavioral changes in epilepsy that needs attention is dysfunctional behavior. Depression is also a common problem that goes unrecognized and untreated. Other treatable problems include impotence, anxiety, panic attacks, and psychosis. (O Devinsky, B Vazquez – Behavioral changes associated with epilepsy) 

  1. Can you drive if you have epilepsy?

Seizures can prove to be dangerously fatal if they occur while driving. Thus. If a person experiences seizures, regardless of being epileptic or not, in an immediate effect it is advised to stop driving. Different countries have different guidelines for the same. For instance,  in England, Scotland and Wales you need to tell the Driver and Vehicle Licensing Agency (DVLA). In Northern Ireland you need to tell the Driver and Vehicle Agency (DVA). 

  1. What should I do if I have a seizure and I’m home alone?

There is nothing much you can do. You should try knowing your triggers to keep a track on it and have a proper response plan made with the help of your doctors. For extra caution, you should get rid of any objects that might hurt you in any way. If it is your first time experiencing a seizure, you can call 911 and your family to inform them about your seizure episode. If you have experienced it before, then you can call your doctor to inform him about it. Some people experience an aura before the seizure, in that case, you can call to inform your family about it, you can lie down to a place away from any objects. 

  1. How accurate are EEG reading seizures?

EEG (electroencephalogram) is used to diagnose the cause of symptoms, such as seizures or memory loss. An EEG evaluates brain function by looking at the electrical activity within the brain, that appear as waves. The basic brain waves are alpha, beta, theta, and delta waves. Doctors examine each facet of the wave and determine unusual activities. 

However, EEG only shows brain activity during that particular time. Therefore, a person experiencing seizures can have a normal EEG. Stats demonstrated that approximately one-half of all EEGs done for patients with seizures give normal results. 

  1. How can Epilepsy be cured?

Drugs and medications can control Epilepsy. These medications do not cure epilepsy, but can often control seizures very well. More than 20 different types of medications are available. About 80% of people with epilepsy today have their seizures controlled by medication at least some of the time. The first step towards managing a seizure is to prescribe Anti-epileptic drugs (AEDs), which help in reducing the number of seizures. 

  1. How can surgery treat epilepsy?

If in some patients AEDs fail to bring the desired results, they undergo different types of neurosurgery depending on the type of seizure. Surgery can remove the specific area of the brain thought to be causing seizures, or it also can involve separating the part of the brain that is causing seizures from the rest of the brain.

However, with surgery comes risks as well that varies from person to person and can range from memory, a partial loss of sight, depression to other mood problems.

  1. What is the best treatment or medicine for epilepsy?

Treatment for epilepsy includes antiepileptic medications (AEDs), diet therapy, and surgery. Anticonvulsant therapy in adults comes into consideration usually after two unprovoked epileptic seizures. The various classes of AEDs include sodium channel inhibitors, calcium channel inhibitors, GABA A receptor agonists, synaptic vesicle protein SV2A modulator, Na/Ca channel modulators and AMPA receptor blockade.

Epidiolex is the first prescription, plant-derived cannabis oral formulation developed by the GW

Pharmaceuticals. Xcorpi (cenobamate) is an FDA-approved AED for the treatment of partial-onset seizures in adults. Nayzilam is an investigational midazolam formulation developed for the rescue treatment of seizures in patients who require control of intermittent bouts of increased seizure activity. Fintepla, is an oral medication that is a low-dose solution of fenfluramine hydrochloride. 

  1. What is the difference between epilepsy and hysteria?

While Epilepsy is a commonly occurring neurological disorder characterized by recurring and unprovoked seizures, Hysteria, on the other hand, is usually a fear related to a certain part of the body or an imaginative state of mind. 

  1. What is the difference between epilepsy and eclampsia?

Preeclampsia is a complication that arises during pregnancy leading to high blood pressure and damage to another organ system, most often the liver and kidneys. Severe Preeclampsia can also lead to seizures known as Eclampsia. Less than 1% of women who have preeclampsia experience seizures. (Habli M, Sibai BM (2008))

  1. What is the average lifespan of an epileptic?

Most people with epilepsy live a full life. However, this does not rule out the the risk of early death.  

Not many have read or heard about Epilepsy. The public awareness and attitudes towards epilepsy vary from negative, neutral to positive as well, depending upon the understanding of the disease among common people. To tackle the situation, several organizations are running campaigns, and awareness programmes to help those living with Epilepsy and add to their quality of lives.

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UCB Taps Medisafe to Develop Branded Digital Drug Companions for Antiepileptic Medications

UCB Taps Medisafe to Develop Branded Digital Drug Companions for Antiepileptic Medications

What You Should Know:

– UCB has selected Medisafe to develop branded digital
drug companions for antiepileptic medications, marking the company’s official
entry into the digital therapeutics space.

– The initial collaboration will primarily be focused on their antiepileptic medications, but they are exploring its use for additional brands. 


Medisafe,
a leading digital
therapeutics
company specializing in digital companions, has been selected
by UCB to develop branded digital drug
companions for its antiepileptic medications, with greater capabilities to
expand across additional brands. The digital companions streamline support for
patients to access financial assistance, patient diaries, and doctor discussion
guides throughout their treatment journey.

UCB is launching both digital companions in November in
support of National Epilepsy Awareness Month and the more than 3.4 million
patients in the US who live with the neurological condition. 1 in 26 people in
the US will develop epilepsy at some point in their lives and UCB wants to make
managing medication therapies easier through new digital companions from Medisafe. UCB
is a leader in antiepileptic medications commonly used to treat epilepsy and
the new digital experience for users will deliver condition-specific
content to help support patients through any medication challenges. To
date, nearly 7MM users rely on Medisafe’s digital therapeutics platform,
which applies real-world evidence to build connected medication management
programs and influence patients’ behavior on therapy. 

The collaboration will raise awareness and drive engagement
with a content-rich digital experience for patients to gain support and
community throughout the course of their treatment. The Medisafe app
is available to Android and iPhone users through both the Google play and Apple
app stores. Patients can experience the antiepileptic medication resource
centers within the Medisafe app, unlocking a world of advanced
patient support and guidance as a result of this collaboration. 

“At UCB, we focus on fostering collaborations that deliver a purposeful impact to people living with epilepsy. As part of our ongoing digitalization efforts, the Medisafe app will allow us to continue supporting patients with new, innovative ways of navigating their health,” said Anita Moser, Head of Assets and Optimization for U.S. Neurology, UCB. “During the COVID crisis, the ability to support patients digitally is more important than ever, and we are pleased to deliver personalized and immediate support directly to epilepsy patients and their caregivers.”

Ovid drug reduces seizure frequency in two rare forms of epilepsy, according to early Phase II data

The data from a Phase II pilot and an extension study of soticlestat, also known as OV935 or TAK-935, showed short- and long-term reductions of seizure frequency in patients with CDKL5 deficiency disorder and Dup15q syndrome.

Sanofi faces possible manslaughter charges in epilepsy drug probe

Sanofi has been placed under formal investigation in France for possible charges including manslaughter relating to the epilepsy drug Depakine, following the deaths of four babies whose mothers took the drug.

Depakine was found to carry a high risk of birth defects if taken by pregnant women.

Sanofi, which denies wrongdoing and says it warned of the risks long ago, is already being prosecuted in France following allegations it provided misleading information about the drug.

The drug is widely prescribed under different names as a treatment for epilepsy and other forms of seizure.

Although there have been warnings for years that the drug should not be given to pregnant women, complainants in France say this was never adequately communicated.

As a result thousands of children were born with physical or psychological problems because of the increased risk of birth defects or autism in their babies.

It is unclear whether the matter will go to trial, the BBC reported.

A spokesperson for Sanofi said: “As part of the investigation on Depakine opened at the Court of Justice of Paris for nearly four years, Sanofi Aventis France was indicted for aggravated deception, involuntary injuries and recently for manslaughter.

“The pharma company has referred the matter to the Chamber of Inquiry in order to challenge that indictment.

“All these elements prejudice in no way the responsibility of the pharma company.

“Sanofi Aventis France has complied with its disclosure obligations and is challenging the merits of these lawsuits.”

In 2018, the European Medicines Agency’s safety committee recommended new measures to avoid unborn babies becoming exposed to valproate.

The Pharmacovigilance Risk Assessment Committee (PRAC) made recommendations including a visual warning about the risks in pregnancy, possibly including a symbol or pictogram to be adapted at national level.

In migraine or bipolar disorder the PRAC said valproate must not be used during pregnancy, and not in women who are thinking of having babies.

In epilepsy the PRAC said it must not be used unless it is impossible to discontinue treatment.

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