VANCOUVER, Jan. 11, 2021 — VANCOUVER, January 12, 2021 – BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU), an emerging biotech focused on the development and commercialization of cutting-edge treatments in mental disorders and viral infections, is pleased to provide an overview of the Company’s primary plans for this calendar year to develop 3 novel therapeutic products, each addressing significant unmet needs with multi-billion dollar market potential.
“The last 6 months of 2020 have been a very transformational time period for BetterLife, filled with milestones, an appreciating stock price and the development of a future roadmap to increased growth and shareholder value. 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. We are also seeing great progress in our development of AP-003 for the treatment of pandemic respiratory viral infections and AP-001, a cream formulation for the treatment of humanpapilloma virus (HPV). We are very much looking forward to our meeting with the USFDA in early March. Today, I am proud and excited to share this roadmap for 2021 and beyond with the past, present and future shareholders of our emerging company,” said Ahmad Doroudian, CEO of BetterLife.
TD-0148A (2-bromo-lysergic acid diethylamide; 2-bromo-LSD) is an orally administered non-hallucinogenic analog of LSD. BetterLife plans to develop TD-0148A for the treatment of mental disorders such as severe depression, post-traumatic stress disorder and substance dependencies. The Company’s initial clinical focus will be on treatment-resistant depression.
BetterLife is planning to have a pre-IND meeting with the USFDA in Q2 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 authorities’ approvals, the Company is also planning independent investigator studies in parallel with the IND filing to begin in Q1-Q2 2021.
TD-0148A’s patented process allows for cost effective manufacturing of TD-0148A, does not use LSD as a starting point nor generates LSD at any stage in the process. The Company will conduct process development, scale-up and GMP manufacturing of TD-0148A during this calendar year, leading up to the IND. The Company will also conduct the necessary IND-enabling preclinical studies in the same time frame.
AP-003 is a BetterLife patent protected interferon alpha-2b (IFN-a2b) inhalation formulation. The Company is developing AP-003 for the treatment of pandemic respiratory viral infections, with the initial focus being on early stage COVID-19. AP-003 can be self-administered by the patient at home via a nebulizer. Based on guidance received from the USFDA, the Company has initiated the necessary preclinical IND-enabling studies, with the goal to file the IND by Q3 2021.
Subject to health regulatory authorities’ approvals, the Company is also considering conduct of AP-003 trials in COVID-19 patients in Q1-Q2 2021 in ex-North American territories, using previously manufactured AP-003.
The Company is quite advanced in its process development and scale-up of its proprietary IFN-a2b manufacturing, which it aims to complete by end of Q1 2021. If these studies are executed, 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. The Company hopes to be able to initiate a registration directed study in the US following the IND.
AP-001 is a BetterLife patent-protected IFN-a2b cream formulation. The Company is developing AP-001 for the treatment of human papillomavirus (HPV) induced high-grade cervical intra-epithelial neoplasia, the precursor to cervical cancer. Current treatments for this indication are all invasive with risk of side effects requiring professional health care intervention.
AP-001 is being developed as a patient self-administered (once-daily) intra-vaginal cream as a 6-week treatment. By Q3 of 2021, the Company plans to have completed process development and scale-up of the AP-001 cream and initiate GMP manufacturing. The Company plans to have a pre-IND meeting with the USFDA in Q3 2021 and initiate the IND-enabling studies shortly thereafter, with the goal to file an IND by Q1 2022.
About BetterLife Pharma Inc.
BetterLife Pharma Inc. is an emerging biotechnology company engaged in the development and commercialization of next generation psychedelic products for the treatment of mental disorders. Utilizing drug delivery platform technologies BetterLife is 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).
For further information please visit www.abetterlifepharma.com.
Ahmad Doroudian, Chief Executive Officer
Email: [email protected]
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