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BetterLife Enrolls First Patient in Interferon alpha-2b COVID-19 Trial in Chile

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BetterLife Pharma has initiated the IN2COVID trial in collaboration with Pontificia Universidad Católica de Chile, enrolling the first patient. This Phase 1-2 trial will evaluate AP-003, an inhaled interferon alpha-2b product, in COVID-19 patients. The trial includes a randomized placebo-controlled Phase 1 and a Phase 2 segment for patients diagnosed within five days. Dr. Ahmad Doroudian, BetterLife's CEO, expressed enthusiasm for the collaboration, while experts emphasized the need for effective treatments given emerging variants and breakthrough infections.

Positive
  • First patient enrolled in the IN2COVID trial, indicating progress in COVID-19 treatment.
  • Collaboration with leading Chilean university enhances the trial's credibility.
  • AP-003 may address COVID-19 treatment gaps amid vaccine limitations.
Negative
  • None.

VANCOUVER, British Columbia, Sept. 22, 2021 (GLOBE NEWSWIRE) -- BetterLife Pharma Inc. (“BetterLife” or the “Company”) (CSE: BETR / OTCQB: BETRF / FRA: NPAU) today announced that its wholly owned subsidiary, Altum Pharmaceuticals Inc. (“Altum”), and Pontificia Universidad Católica de Chile have enrolled the first patient in the Phase 1 portion of the Phase 1-2 randomized placebo controlled (“IN2COVID”) in COVID-19 patients. The trial tests BetterLife’s proprietary inhaled interferon alpha-2b product, AP-003.

The IN2COVID trial (ClinicalTrials.gov Identifier: NCT04988217) consists of a randomized placebo Phase 1 portion in healthy subjects followed by a randomized placebo-controlled Phase 2 portion in early stage COVID-19 patients (<5 days of diagnosis of COVID-19). The IFN-α2b treatment arms will receive BetterLife’s proprietary inhaled IFN-α2b product, AP-003, administered via nebulizer, twice daily for 10 days.

"We are excited to be able to initiate this trial of AP-003 in COVID-19 patients in collaboration with the Escuela de Medicina (School of Medicine) at the Pontificia Universidad Católica de Chile,” said BetterLife’s Chief Executive Officer, Dr. Ahmad Doroudian. “The team, as well as the trial center, are the leaders in Chile in conducting COVID-19 trials.”

Dr. Arturo Borzutzky, Study Director of the IN2COVID trial and Associate Professor and Head of Pediatric Immunology, Allergy and Rheumatology at the School of Medicine of Pontificia Universidad Católica de Chile said, "We are pleased to be partnering with Altum to bring AP-003 to COVID-19 patients.” He added, “There are several reasons why there is a need for an effective, easy to administer, non-invasive treatment, such as AP-003, for COVID-19. These reasons include: emergence of SARS-CoV-2 variants, not knowing the duration of protection afforded by the current vaccines and the reality of breakthrough infections in vaccinated individuals.”

Dr. Eleanor Fish, one of the Principal Investigators of the trial, commented, “AP-003, being a Type I interferon, is a broad acting antiviral agent and, therefore, may be effective in all the scenarios described by my colleague Dr. Borzutzky.” Dr. Fish is a Professor in the Department of Immunology, University of Toronto, and Emerita Scientist at the Toronto General Hospital Research Institute, University Health Network. Dr. Fish is the principal author of the exploratory trial published in 2020 in Frontiers of Immunology titled "Interferon-α2b Treatment for COVID-19", which examined the outcome of treating a cohort of 77 individuals with confirmed COVID-19 admitted to Union Hospital, Wuhan, China, with inhaled interferon-α2b. The study revealed the therapeutic benefits of Interferon-α2b treatment in patients with early COVID-19. The authors concluded that a randomized clinical trial was warranted in moderate cases of COVID-19 and "treatment with IFN-α2β may benefit public health measures aimed at slowing the tide of this pandemic, in that this exploratory study demonstrated that duration of viral shedding was shortened, and lung abnormalities and systemic inflammation were significantly reduced." The current IN2COVID trial in Chile was designed to test these.

About BetterLife Pharma

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 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.

For further information, please visit www.abetterlifepharma.com.

About Pontificia Universidad Católica de Chile:

Founded in 1888, Pontificia Universidad Católica de Chile is currently one of the leading higher education institutions in Latin America, ranked first in the continent for three years in a row by the Times Higher Education Ranking. Universidad Católica aspires to achieve excellence in the creation and transfer of knowledge and in providing a Catholic-based educational experience that motivates both personal growth and the development of an inquisitive and critical mind. One of its objectives is to educate persons who are committed to the construction of a more just and prosperous society. The University is an important national center for research in social sciences, natural sciences, health, economics, agriculture, philosophy, theology, arts and literature. Located in a young and geographically distant country, the University believes that maintaining an active exchange program with foreign universities is crucial for academic development.

For further information, please visit https://www.uc.cl/en.

About University Health Network

University Health Network consists of Toronto General and Toronto Western Hospitals, the Princess Margaret Cancer Centre, Toronto Rehabilitation Institute, and The Michener Institute of Education at UHN. The scope of research and complexity of cases at University Health Network has made it a national and international source for discovery, education and patient care. It has the largest hospital-based research program in Canada, with major research in arthritis, cardiology, transplantation, neurosciences, oncology, surgical innovation, infectious diseases, genomic medicine and rehabilitation medicine. University Health Network is a research hospital affiliated with the University of Toronto.

For more information, visit: www.uhn.ca

Contact Information

BetterLife Pharma:

Ahmad Doroudian, Chief Executive Officer
Email: ahmad.doroudian@blifepharma.com
Phone: 604-221-0595

Media enquiries:

Buchanan
Henry Harrison-Topham / Jamie Hooper / Ariadna Peretz
Phone: +44 (0) 20 7466 5000
Email: betterlife@buchanan.uk.com
www.buchanan.uk.com

Pontificia Universidad Católica de Chile:

Camila Díaz, Journalist
School of Medicine Communications Department
Email: cdias@uc.cl
Phone: +569-72117700

Natalia de la Puente, Journalist
School of Medicine Communications Department
Email: ncdelapuente@uc.cl
Phone: +569-76950837

Cautionary Note Regarding Forward-Looking Statements

No securities exchange has reviewed nor accepts responsibility for the adequacy or accuracy of the content of this news release. This news release contains forward-looking statements relating to product development, licensing, commercialization and regulatory compliance issues and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include the failure to satisfy the conditions of the relevant securities exchange(s) and other risks detailed from time to time in the filings made by the Company with securities regulations. The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by applicable law.


FAQ

What is the BetterLife Pharma IN2COVID trial?

The IN2COVID trial is a Phase 1-2 randomized placebo-controlled study evaluating BetterLife Pharma's inhaled interferon alpha-2b product, AP-003, in COVID-19 patients.

Where is the IN2COVID trial being conducted?

The IN2COVID trial is being conducted in collaboration with Pontificia Universidad Católica de Chile.

What is the purpose of the AP-003 treatment in the trial?

The AP-003 treatment aims to determine its efficacy in treating COVID-19 patients, especially in those diagnosed early.

What are the phases of the IN2COVID trial?

The IN2COVID trial consists of a randomized placebo Phase 1 followed by a Phase 2 portion for early-stage COVID-19 patients.

When was the first patient enrolled in the IN2COVID trial?

The first patient in the IN2COVID trial was enrolled on September 22, 2021.

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