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 a busy 2021 product development roadmap for its psychedelic products, AP-003 coronavirus nebulizer and AP-001 cream. CEO Dr Doroudian told investors recently that the company is seeing “great progress” in its development of AP-003, an interferon alpha-2b (IFN-a2b) inhalation formulation and AP-001, a cream formulation for the treatment of humanpapilloma virus (HPV) induced high-grade cervical intra-epithelial neoplasia, the precursor to cervical cancer.

Dr Doroudian said the company is looking forward to its Investigational New Drug Application (IND) meeting with the US Food and Drug Administration (FDA) in early March.

Subject to health regulatory approvals, BetterLife said it is also considering AP-003 trials in COVID-19 patients in “1Q-2Q of 2021 in ex-North American territories, using previously manufactured AP-003.”

BetterLife is scaling up its proprietary IFN-a2b manufacturing, which it aims to complete by the first quarter of this year. A bridging clinical trial between the old and new manufactured AP-003 will also be conducted to enable use of the ex-North American data as supportive for the US IND application. The firm hopes to be able to initiate a registration directed study in the US following the IND.

BetterLife has chosen Jakarta-based Equilab International as the contract research organization (CRO) to manage upcoming clinical trials of its proprietary formulation of Interferon alpha2b (AP-003) in mild to moderate cases of the coronavirus.

In January, Betterlife confirmed the stability of its inhalable interferon COVID-19 treatment through six months of real-time cold-temperature testing. The testing was conducted at -20°C (-4°F) and +2-8°C (36-46°F), which represents standard freezer and refrigerator temperatures, and the interferon met all established stability testing criteria.

Meanwhile, AP-001 is being developed as a patient self-administered (once-daily) intra-vaginal cream as a six-week treatment. By the third quarter, the firm plans to complete process development, scale-up of the AP-001 cream and initiate manufacturing. BetterLife plans to have a pre-IND meeting with the FDA in 3Q 2021, and initiate the IND-enabling studies with the goal to file an IND by the first quarter of 2022.

In January, BetterLife applied for patent protection for its new 2-Bromo-LSD (TD-0148A) formulations to treat severe depression, post-traumatic stress disorder (PTSD) and substance dependencies. The initial clinical focus will be on treatment-resistant depression. 2-Bromo-LSD is a nontoxic second-generation LSD-derived molecule that mimics the therapeutic potential of LSD, without the psychedelic effects or hallucinations.

BetterLife is planning to have a pre-IND meeting with the FDA in 2Q 2021, with the goal to file an IND and initiate a Phase 1 clinical trial in healthy volunteers in this calendar year. Subject to health regulatory approvals, the firm is planning independent investigator studies in parallel with the IND filing to begin in the first or second quarter of 2021.

In January, the Canadian company said Eurofins Discovery will be conducting the IND-enabling in-vitro preclinical primary pharmacology and safety pharmacology studies on TD-0148A at its facilities at Eurofins Cerep, DiscoverX and Panlabs.

BetterLife’s recent C$10 million acquisition of the assets of Transcend Biodynamics makes it the only company able to synthesize 2-Bromo-LSD utilizing a patented process which obviates the need to first synthesize LSD-25 – eliminating the regulatory barriers of working with a Schedule 1 substance. In January, the company said that Health Canada had confirmed that LSD derivative 2-Bromo-LSD is not classified as a controlled substance.

BetterLife said it will conduct process development, and manufacturing of TD-0148A during this calendar year, leading up to the IND. It will also carry out the IND-enabling preclinical studies in the same time frame.

In February, BetterLife Pharma revealed that it has filed patent protection for the newest compound to enter its pipeline - dihydrohonokiol-B (TD-010). Specifically, the company said the patent protection concerns the use of TD-010 as a treatment for sedative, hypnotic, or anxiolytic-use disorder.

Inflection points:

• Completion of the AP-003 Phase 2 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 boss says:

“The last six months of 2020 have been very transformational for BetterLife, filled with milestones, an appreciating stock price and the development of a future roadmap to increase growth and shareholder value,” BetterLife CEO Ahmad Doroudian has said in recent corporate update.

“We are aggressively developing cutting edge next generation psychedelic products, such as TD-0148A, to become a leader in an emerging market with a projected $6.85 billion value by 2027 alone.”

Contact the author Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive

Story by ProactiveInvestors