BetterLife Pharma has a promising pipeline of psychedelic products, a coronavirus nebulizer and AP-001 cream

• Three compelling and differentiated assets
• Potential coronavirus treatment AP-003’s Phase 2 trial to start in 2Q 2021
• Management team led by veteran entrepreneur CEO Dr Ahmad Doroudian

What BetterLife Pharma does:

BetterLife Pharma Inc (CSE:BETR) (OTCQB:BETRF) (FRA:NPAU) is a life sciences company engaged in the development of next-generation psychedelic products for the treatment of mental disorders.

Additionally, by utilizing drug delivery platform technologies, BetterLife is also refining and developing drug candidates from a broad set of complementary interferon-based technologies, which have the potential to engage the immune system to fight virus infections, such as the coronavirus disease (COVID-19) and human papillomavirus (HPV) and directly inhibit tumours to treat specific types of cancer.

The Vancouver, British Columbia-based company was formerly known as Pivot Pharmaceuticals Inc and changed its name to BetterLife Pharma in December 2019.

The company has at least three compelling and differentiated assets. The firm is aggressively developing psychedelic products, such as TD-0148A, to become a leader in an emerging market.

The biotech firm is also developing AP-003 for the treatment of pandemic respiratory viral infections and AP-001, a cream formulation for the treatment of humanpapilloma virus (HPV).

A serial entrepreneur, BetterLife Pharma CEO Dr Ahmad Doroudian is the founder of several companies including Merus Labs International, PanGeo and Altum Pharmaceuticals. Significantly, BetterLife completed a “merger of equals” with Altum Pharma and is advancing Altum’s pipeline, especially AP-003 and its potential as a COVID-19 treatment.

How is it doing:

BetterLife Pharma has had a busy 2021 so far with a product development roadmap for its products.

On March 23, the company said it had signed an agreement with the laboratory of Dr Adam L. Halberstadt at the University of California San Diego (UCSD) for pre-clinical behavioral pharmacology studies of TD-0148A, which is a second-generation lysergic acid diethylamide (LSD) derivative that the company believes will mimic the therapeutic potential of LSD without producing hallucinogenic effects or other psychoactive side-effects.

As part of the research agreement, BetterLife said it will work with Halberstadt’s team to test TD-0148A in various preclinical models that are established in their lab and use their expertise in understanding how psychedelics and related compounds interact with the serotonergic system and how those molecules could be developed to treat psychiatric and neurodevelopmental disorders.

Earlier in March, BetterLife had said it was partnering up with Carleton University in Ottawa to study TD-0148A to treat depression. The company reckons the therapy will mimic the projected therapeutic potential of LSD without causing undesirable psychoactive dissociative side effects. 

The university’s head of neuroscience Dr Argel Aguilar-Valles and his team will work with BetterLife to test TD-0148A in both in vitro and in vivo models in the lab in a bid to understand the molecular mechanisms that underlie psychiatric and neurodevelopmental disorders.

And in the same month, BetterLife revealed that it had signed an agreement with Eurofins CDMO (contract development and manufacturing organization) Alphora Inc for the manufacturing of TD-0148A. Eurofins CDMO will conduct process development, scale-up and GMP (good manufacturing practice) manufacturing of TD-0148A at its plant facility in Mississauga, Ontario. The manufacturing will be based on BetterLife’s proprietary process that does not involve any controlled substances, the company said

On the coronavirus front, also in March, BetterLife announced that its wholly-owned subsidiary Altum Pharmaceuticals had entered into a Letter of Intent with Pontificia Universidad Católica de Chile to conduct a randomized, placebo-controlled trial in COVID-19 patients testing Altum’s proprietary inhaled interferon alpha-2b product AP-003. 

The IN2COVID trial is projected to start in the second quarter of this year and be completed by the end of 3Q. Interferon alpha-2b (IFN-a2b), a Type I interferon, is a naturally occurring protein integral to the body’s first line of anti-viral defenses. BetterLife said there is evidence that coronaviruses, such as SARS-CoV-2, have mechanisms that suppress IFN-a2b production, allowing the virus to evade the innate immune system.  

BetterLife said the goal of the IN2COVID trial is to confirm the benefit of inhaled IFN-a2b in early-stage COVID-19 patients.

On the personnel front, in April, the company announced the appointment of a former Food and Drug Administration (FDA) Psychiatry Division director, Thomas Laughren as a regulatory advisor. 

Laughren led the Division of Psychiatry Products and the Center for Drug Evaluation and Research at the FDA. He oversaw the review of all psychiatric drug development activities conducted under investigational new drugs (INDs) and the review of all new drug applications (NDAs) and supplements for new psychiatric drug claims, the company said. 

The company also named The Conscience Fund’s founder Henri Sant-Cassia to its board of directors. The US$60 million fund is one of the most active venture funds in psychedelic medicine. He has helped create over $200 million in company valuations within the psychedelic sector.

And in a boost for its shares at the end of March, BetterLife revealed that its stock has been added to the high-profile Horizons Psychedelic Stock Index ETF after its first quarterly rebalance of holdings. The world’s first exchange-traded fund (ETF) offers exposure to North American securities that have significant exposure to the rapidly-growing psychedelics industry. The proprietary index is operated by Horizons ETFs, and Solactive AG is the independent calculation agent for the index.

In May and June, the company raised more than $9 million in capital to fund its operations. 

Inflection points:

• Completion of the AP-003 Phase 2 coronavirus trial, and approval under emergency use authorization
• Advancing AP-001 as potentially the first treatment to prevent/halt HPV
• Progressing second-generation psychedelic compounds to address unmet needs in mental health

What the broker says:

On June 28, Research Capital Corporation said investors should give BetterLife a look as it advances the development of its two promising therapeutics — TD-0148A and interferon (IFNα2b)

In its Enterprise publication, which provides valuable insight into companies that have distinguished themselves, the firm also noted BetterLife’s experienced management team led by CEO Ahmad Doroudian who was previously the founder and former CEO of specialty pharma company Merus Labs International, which Norgine acquired for C$342 million in 2017. Also, BetterLife CFO Moira Ong was the former CFO of Merus Labs.

As BetterLife moves ahead with TD-1048A, Research Capital noted that the candidate stands out from rival psychedelic medicine compounds. 

“What is unique about TD-0148A is it does not have any hallucinogenic side effects (thus patients would not need to be treated in clinics) and more importantly due to its very clean safety profile it is a non-scheduled drug,” the firm said. “This neurological program for major depressive disorder can be viewed as a potential out of the money call option – it could provide considerable upside to the stock if the results for TD-0148A pan out well.”

Meanwhile, Research Capital noted a recent Chinese study showed that Interferon significantly reduced the duration of detectable viruses in the upper respiratory tracts of COVID-19 patients. 

“Investors should also take note that a UK biotech company called Synairgen PLC soared over 300% after the company released its COVID-19 trial results using its nebulized form of interferon β-1a (IFNβ1a) (known as SNG001),” the firm said.

Research Capital also pointed to BetterLife’s two ongoing studies of the therapy in Chile and Australia, underscoring the product’s advancement. 

What the boss says:

In a June statement, CEO Ahmad Doroudian called TD-0148A “a potential novel new therapy to treat debilitating psychiatric disorders with high unmet need,” including treatment-resistant severe depression and post-traumatic stress disorder.

“BetterLife’s goal is to bring this treatment to Investigational New Drug (IND) application and the clinic as soon as possible, and the scientific expertise of Carleton University’s team headed by Dr. Argel Aguilar-Valles at the Department of Neuroscience, is an ideal partner to help us realize our vision,” Doroudian said.

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Story by ProactiveInvestors