Behavioural disorders like Attention Deficit Hyperactivity Disorder (ADHD) affects children and adults and impacts negatively across all aspects of their life, from schooling to work to relationships. The US Center for Disease Control and Prevention (CDC) says that 11% of American children between the ages of four to 11 have some form of ADHD. Moreover, those figures look set to rise.
Treatment options are important and can significantly affect the quality of life for children and adults affected by this condition. This dilemma is why a company like NLS matters.
NLS is a Swiss-based clinical-stage biotechnology company focused on developing innovative, more effective and safe treatments for ADHD. We talked to their inspirational co-founder and CEO Alex Zwyer about NLS, their innovations in ADHD treatment and their plans for the future.
Why is ADHD an important condition to manage?
Patients with ADHD suffer from difficulty with inattention, hyperactivity or impulsivity, often in multiple settings. The condition negatively affects patient’s success in school, at work and in their personal relationships and inhibits a patient’s ability to realise his/her full potential.
We at NLS feel that it is absolutely critical that more effective and safe treatment options be available for those with the condition, to improve quality of life for themselves and their family and friends. Good treatment can make a huge difference, and there is no reason why people with ADHD can’t live a relatively normal life.
What made you and your company want to specialise in the treatment of ADHD?
ADHD is a disorder with significant unmet medical need. We believe treatment rates and patient outcomes could be improved with a new treatment that is as effective as currently available stimulants, while also having an improved safety profile. This drug is called mazindol.
Dr Eric Konofal, Chief Scientific Officer and co-founder of NLS Pharma, discovered the robust effect of mazindol on the symptoms of ADHD while treating his patients for other disorders.
Mazindol CR is unique because it is a serotonin–norepinephrine–dopamine reuptake inhibitor (SNDRI). None of the currently approved pharmacological treatments are considered to be SNDRIs. They do not promote a regulatory effect on 5-HT1A, 5-HT7, or the hypothalamic orexin system. Why does that matter?
Orexin fibres are dense brain regions crucial for wakefulness and arousal – particularly the locus coeruleus that contains adrenergic, noradrenergic, histaminergic, and serotonergic neurons. Orexin neuropeptides are known to play important modulatory roles in sleep regulation, motivation, reward and emotional and attentional regulation.
Dr Konofal executed a pilot study that documented the effectiveness of mazindol for the treatment of children with ADHD. Upon reviewing the results, we concluded that mazindol held significant potential as a game-changing treatment for patients with ADHD.
We immediately began designing a well-controlled, multi-centre phase II study within the adult population to confirm the pediatric findings. Those results exceeded our expectations, and we are currently designing our pivotal trial program.
What are the problems with the way ADHD is managed right now?
Current stimulant treatments are effective at improving the symptoms of ADHD but have significant risk associated with their undesirable safety profile.
All methylphenidate and amphetamine/lisdexamfetamine products are designated as Schedule II medications by the U.S. Drug Enforcement Agency (DEA), meaning they come with a high potential for abuse and dependence. It is the same classification as many narcotic painkillers (for example, Percocet and OxyCotin), fentanyl, methamphetamine, methadone, to name a few.
Non-stimulants treatment options, such as atomoxetine, are not as effective as stimulants and carry significant warnings and precautions such as thoughts of suicide, severe liver injury and serious cardiovascular event risk.
With these kinds of side-effects, it is evident we need to work hard to create safer alternatives, particularly as this is a condition that also implicates children.
What have been your core pharmaceutical breakthroughs in the treatment of ADHD?
Our research shows that mazindol has an effect on dopamine and norepinephrine, two validated neurotransmitter targets of ADHD.
We believe one of our core breakthroughs in the treatment of ADHD is our deepening understanding of mazindol’s effect on two novel neurotransmitters (serotonin and orexin 2) that are not currently targeted by any other ADHD treatment.
This novel MOA has the potential to explain our unprecedented efficacy and safety profile.
Obviously, innovation is at the centre of what any medically-focused company should be interested in, but to what do you attribute your success as a company?
We attribute our success to our patient-centred culture. We put the patient at the heart of everything we do, hence our focus on finding better and safer treatment options.
It is also about our staff. We have assembled an all-star team of research, drug development and commercial leaders that are unified by our commitment to patients with ADHD around the globe.
What is your ultimate ambition in the treatment of ADHD?
We intend to revolutionise the treatment of ADHD with our principal asset, Mazindol CR.
For years physicians and parents of children with ADHD have been asking for a treatment that is as effective as current CII stimulants but with an improved safety profile.
We expect that our phase III trials will confirm our profile as a potentially game-changing ADHD treatment that is as effective as currently available stimulants. Moreover, we expect significantly less potential for abuse, misuse and diversion.
The whole process of patient management will be easier for parents and prescribers too because prescriptions could be re-filled and called-in to the pharmacy.
So, in the near future, our ambition is to establish Mazindol CR as a viable treatment option.
However, also, we expect to continue to work on other treatment options. Like anyone committed to their work, we will not rest until we have an effective way of managing ADHD, which we believe will change the way the condition is viewed and understood.