TD-0148A

In a nutshell: TD-0148A is a non-regulated, non-scheduled, and non-hallucinogenic psychedelic compound that BetterLife is developing to treat major depressive disorders and cluster headaches.

More explanation:

TD-0148A is a second-generation Lysergic Acid Diethylamide (“LSD”) derivative molecule that mimics the projected therapeutic potential of LSD. Due to its non-regulated & non-scheduled status, it will be cheaper to develop than LSD. In addition, due to its non-hallucinogenic nature, more people will want to use it and makes it possible for patients to self-administer the treatment in the comfort of their own home without supervision by a trained therapist, thereby making it cheaper to consume than other psychedelic options that require the presence of at least one trained individual. We believe that all of these factors significantly lower the price point meaning insurers will be more likely to cover the treatment.


BetterLife’s synthesis patent for TD-0148A eliminates regulatory hurdles and its pending patent for method of use covers treatment of major depression, cluster headaches and neuro-psychiatric and neurological disorders.


TD-0148A is currently in preclinical pharmacology and other IND-enabling studies and, in 2022, BetterLife will file its IND and start Phase 1 human clinical trials. The initial target indications are projected to be major depressive disorder and cluster headaches.

Market value:

The global depression drugs market reached US$12.41 billion in 2019 and it is projected to reach near US$25 billion by 2030. According to the WHO, depression is one of the leading causes of disability, impacting approximately 265 million people in the world.

DISCOVERY PRE-CLINICAL

IND

Phase 1

Phase 2

Phase 3

TD-010

In a nutshell: TD-010 is a treatment BetterLife is developing to treat benzodiazepine dependency and anxiety.

More explanation:

TD-010 is based on Honokiol, the active anxiolytic ingredient of magnolia bark. honokiol has been used for centuries to treat anxiety. BetterLife is developing TD-010, a derivative of honokiol that has 20x more anxiolytic activity. In addition, animal studies have shown TD-010 to not have the side effects of benzodiazepines nor be addictive like benzodiazepines.


In 2021, BetterLife developed and filed a US provisional patent on use for treatment of neuro-psychiatric disorders such as benzodiazepine dependency, anxiety and insomnia In 2022 BetterLife plans to conduct IND-enabling studies to be followed by IND and initiation of Phase 1 clinical trials. The initial target indication is projected to be benzodiazepine dependent patients.

Market value:

The global benzodiazepines market is expected to grow to US$4.15 billion in 2017 (from $3.48 billion in 2019) at a CAGR of 2.25%.

DISCOVERY PRE-CLINICAL

IND

PHASE 1

PHASE 2

PHASE 3

AP-003

In a nutshell: AP-003 is a potential treatment for COVID-19 that BetterLife has been developing and is in the process of seeking strategic partnerships for further development.

More explanation:

The inhalation of AP-003 goes directly to the lungs and studies so far have shown it may enable infected cells to halt viral replication and restore the initial immune response to COVID-19. This would lead to a lower hospitalisation and death rate for those who are not vaccinated. The active component of AP-003 is the protein interferon alpha 2b (IFNa2b). IFNa2b is known to have broad acting anti-viral properties. IFNa2b has been studied by University of Texas, showing a 10,000-fold reduction in the quantity of COVID-19 and it has been used to treat COVID-19 in a human trial in China.


It is believed that treatment with early in disease onset (within 5 days of diagnosis or onset of symptoms) be effective in controlling the severity of the disease and its sequelae. There is also the potential for AP-003 to be used as prophylaxis/prevention.


BetterLife’s AP-003 patent application covers potential treatment of and also describes potential prevention/prophylaxis against COVID-19 (and other respiratory tract viral infections). In 2021, BetterLife entered into a clinical research agreement with the Pontificia Universidad Católica de Chile to conduct a randomized placebo-controlled trial in COVID-19 patients. BetterLife has also entered into a research agreement with Western University, Ontario, Canada to test the efficacy of AP-003 against COVID-19 variants in vitro. To date, we have received positive in vitro results on COVID-19 and variants. AP-003 IND filing is projected for H2 2022,

Market value:

There is a considerably large market for COVID-19 treatments. Estimates range from $1.0 bllion to $2.0 billion market for COVID-19 therapies (Eli Liily Press release, Dec 2020)

There is also the potential for AP-003 to be used as prophylaxis/prevention, thereby expanding the market opportunity further.

DISCOVERY PRE-CLINICAL

IND

Phase 1

Phase 2

Phase 3

SEE HOWAP-003
Works

WHY AP-003

SARS CoV 2 coronavirus causes COVID 19. SARS CoV viruses block interferon production in infected cells, allowing the virus to continue replicating unabated ¹.

Treatment with interferon may overcome that block, potentially restoring cells normal anti viral activity.

Interferon alpha 2b (IFNa2b) is a potential treatment for COVID 19 ².

IFNa2b (inhaled) has been used in China on COVID 19 patients.

AP-003 may be given by inhalation at the first signs of COVID 19 with following projected outcomes according to Altum Clin Protocol ALT 003 COV 01 2020 05 04 rationale:

  • AP-003 inhalation applies INFa2b directly to the lungs which may enable infected cells to halt viral replication.
  • AP-003 inhalation may help to restore the initial immune response to COVID 19.
  • AP-003 inhalation 1st proposed target indication: people at higher risk to develop severe COVID 19 disease
  • Potential Result: Reduction of the overall hospitalization rate, long term tissue damage and death by reducing the severity of the disease
  • Potential prevention of long term damage to the lung, heart, kidney and the brain

The Cost Of Poor Mental Health

Mental health challenges and disorders can happen to anyone.

Worldwide, almost 1 billion people suffer from a mental disorder. The global economic cost of mental illness is expected to be more than US$16 trillion over the next 20 years, which is more than the cost of any other non-communicable disease.

Depression

According to the WHO, depression is one of the leading causes of disability and is currently prevalent in nearly 265 million people across the globe (with an estimate that only about 35% cases are reported).

The global depression drugs market reached US$ 12.41 billion in 2019. And the global depression market is projected to reach near US$ 25 billion by 2030.