Creating New Approaches to Treat Mental and Behavioral Health Disorders: NLS-1 Pharma AG

“People with mental health conditions deserve just as much support and compassion as people with physical health conditions.”

- HealthyPlace

As much as our physical strength shapes our existence, it is also our mental capabilities that define and shape our lives. And just like there are physical health disorders, there are many mental health disorders. Unfortunately, the causes of mental health disorders are often unclear, as it may be associated with particular regions or functions of the brain. Simply put, a mental health disorder or illness is basically a behavioral or mental pattern that causes significant distress or impairment of personal functioning.

Among the most common mental health disorders today are depression, bipolar disorder, schizophrenia, dementia and developmental disorders including autism, and Attention Deficit Hyperactivity Disorder (ADHD). ADHD affects children and adults and can impact negatively across all aspects of their life, from schooling to work to relationships.

ADHD is a common disorder that affects focus, self-control and other skills important in daily life. Our understanding of ADHD is evolving with new research, some suggesting that brains of patients with ADHD process data differently than their non-ADHD peers. The US Center for Disease Control and Prevention (CDC) says that 11% of American children between the ages of 4 to 11 have ADHD. Moreover, those figures look set to rise. The right treatment option can significantly improve the quality of life for children and adults affected by this condition.

Creating Possibilities

Patients with ADHD suffer from difficulty with inattention, hyper activity or impulsivity, often in multiple settings. This condition negatively affects the patient’s success in school, at work and in their personal relationships. Moreover, it may inhibit a patient’s ability to realize his/her full potential.

A Swiss-based clinical-stage biotechnology company called NLS-1 Pharma AG is making headway with a prime focus on developing its innovative treatment for ADHD that has many substantial advantages vs. the current standard of care. For many years, physicians and parents of children with ADHD have persistently looked for a treatment that is as effective as the present Schedule II stimulants, but with an improved safety profile. NLS-1 Pharma’s Mazindol CR could be that solution.

Mazindol is a Norepinephrine Reuptake Inhibitor that was previously approved by the FDA for the treatment of obesity. Noradrenergic and dopaminergic systems appear to be implicated in ADHD and an open-label trial of Mazindol demonstrated efficacy in improving the symptoms of ADHD in pediatric patients. NLS-1 Pharma confirmed the efficacy, tolerability, and safety of Mazindol CR among adult patients with ADHD in what is currently considered as the most successful phase II clinical trial in adults with ADHD.

Discovering Solutions

It all started when Eric Konofal, MD/PhD, the Chief Scientific Officer and co-founder of NLS-1 Pharma AG, discovered the robust effect of Mazindol on the symptoms of ADHD while treating his patients for other disorders. Eric Konofal invited Alex Zwyer – with whom he had worked previously on another project – to help him set-up and execute a business plan with the aim to bring Mazindol CR to the market. Thus, NLS-1 Pharma AG was established in the year 2015.

“We design affordable, safe and effective drugs to safeguard and empower the brain throughout all stages of life. Our aim is to improve quality of life and longevity. We are creating new approaches to treat mental and behavioral health disorders, and to enhance cognitive function in healthy people,” Alex Zwyer, CEO and Co-Founder of NLS-1 Pharma AG.

Making a Difference

At present, the stimulant treatments are effective at improving the symptoms of ADHD for some patients but they come with an inherent 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). This means that they all have a high potential for abuse and dependence.       

The methylphenidate and amphetamine/lisdexamfetamine medications carry the same classification as products like Percocet, OxyCotin, fentanyl, methamphetamine and methadone. “The current Opioid Epidemic in the U.S. has sensitized everyone to the destructive potential of abuse and dependence. We at NLS-1 Pharma feel that it is absolutely critical that more effective, safe treatment options be available for those with ADHD, to improve the quality of life for themselves and their family and friends,” explains Alex Zwyer.

Non-stimulants treatment options, such as atomoxetine, are generally less effective than stimulants. Moreover, they also carry significant warnings and precautions such as thoughts of suicide, severe liver injury and serious cardiovascular event risk. Given these substantial risks, it’s quite evident that there’s a dire need to work hard to create safer alternatives for children and adults suffering with ADHD. “An accurate diagnosis and the right treatment can greatly improve the lives of patients with ADHD,” he believes.

NLS-1 Pharma’s research shows that Mazindol has an effect on dopamine and norepinephrine, two validated neurotransmitter targets of ADHD. One of the core breakthroughs achieved by NLS-1 Pharma came when it deepened its understanding of Mazindol’s effect on two novel neurotransmitters (serotonin and orexin 2). These neurotransmitters are currently not targeted by any other ADHD treatment. “This novel MOA has the potential to explain our unprecedented combination of efficacy and safety.”

Research and Development

R&D Strategy

Successful companies of tomorrow will go beyond delivering products, they’ll provide real solutions and services for the serious challenges faced by patients and prescribers. At NLS -1 Pharma, Research & Development is our cornerstone and the company promotes ingenuity through an effective intellectual property policy. The advancements in science and technology have paved the way for our promise of better targeted, more cost-effective treatments. NLS-1 Pharma is ready to take on this challenge. “Our innovative R&D is centered on patients’ needs and delivering affordable, safe and effective solutions,” says the CEO. Not only does it enable the company to improve access to quality healthcare and meet unmet needs, but it will also deliver the sustainable growth required to continue investing in innovative research & development.

R&D Focus

NLS-1 Pharma is active in the field of cognitive enhancement and neurosomatic therapies in particular. These disorders remain largely under-diagnosed and current therapies lack in safety and effectiveness. They are:

• Attentional Disorders (ADHD, ADD, Deficit of alertness)

• Excessive Daytime Sleepiness (Narcolepsy, Hypersomnias)

• Pervasive Developmental Disorders (ASD, Oligophrenia)

• Iron Cerebral Insufficiency (Neuro-Anemia Syndrome, RLS)

• Cognitive Impairments (MCI, AD)

• Synucleopathies (PD, LB)

• Primary Insomnia (SOI)

Bringing it Together

It is clear that ADHD is a disorder with significant unmet medical need. NLS-1 Pharma is working to meet these needs and improve the lives of patients. The organization strongly believes that treatment rates and patient outcomes could be improved with its new treatment, Mazindol CR, which promises to be just as effective as the currently available stimulants while having an improved safety profile.

In the three years since its founding, NLS-1 Pharma is certain of its success to develop better treatment options for patients suffering from ADHD. In the coming year the company is preparing for an end of phase II meeting with the US-FDA in order to start phase III testing of Mazindol CR. The company also extended Leadership Team at the Kick-Off Meeting in New York recently.

Accolades

• Winner of the 2016 Healthcare & Life Sciences Award by the Corporate Livewire

• In 2017, winner of the Innovation Award in Paris awarded by Universal Biotech

• 2018 awarded “Best Quality of Life Improvement Pharmaceuticals Company – Central Europe” by Global Health & Pharma Magazine

• 2018, also named in “The 50 Best Companies to Watch 2018” by Insight Success

• 2018, “Leader in Cognitive Function Enhancing Drug Development” by CV Magazine

• 2018, NLS-1 Pharma’s CEO Alex Zwyer was recognized as “The 10 Best Performing Leaders to Watch, 2018” by Insights Success Business Magazine

Meet the CEO

Alex Zwyer, is the CEO, Co-Founder, and member of the board of directors of NLS-1 Pharma AG. Alex started his career as a marketing assistant in a mid-size pharma company and within 15 years made it to the very top of that firm. Some of the key positions he held were the regional director LATAM, global head marketing & sales, executive VP global markets (responsible for marketing, sales, regulatory affairs and medical affairs globally).

Alex has been described by others as a natural leader and strategist with a track record of producing extraordinary results for more than 25 years. As a co-founder of NLS-1 Pharma, Alex single-handedly fundraised 15 million USD and oversaw a successful execution of what is currently considered as the most successful phase II clinical trials in the ADHD space. Creative and entrepreneurial personality, highly oriented to results, performance and excellence, expertise in strategic planning, alliance development and partnerships, strong ability to influence thinking, and build lasting relationships are his strongholds.

"We intend to revolutionize the treatment of ADHD with Mazindol CR,” says the CEO and co-founder,

Alex Zwyer. “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 with significantly less potential for abuse, misuse, and diversion and the added convenience of prescriptions that can be written with refill and called-in to the pharmacy."

"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 with significantly less potential for abuse, misuse, and diversion."