AntiCovir (interferon a2b inhalation) / BetterLife Pharma - LARVOL DELTA

IN2COVID: Inhaled Interferon α2b for the Treatment of Coronavirus Disease 19 (COVID-19) (clinicaltrials.gov) - P1/2 | N=173 | Completed | Sponsor: Pontificia Universidad Catolica de Chile | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6

IN2COVID: Inhaled Interferon α2b for the Treatment of Coronavirus Disease 19 (COVID-19) (clinicaltrials.gov) - P1/2 | N=173 | Active, not recruiting | Sponsor: Pontificia Universidad Catolica de Chile | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6

IN2COVID: Inhaled Interferon α2b for the Treatment of Coronavirus Disease 19 (COVID-19) (clinicaltrials.gov) - P1/2; N=168; Recruiting; Sponsor: Pontificia Universidad Catolica de Chile; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6 • PCR

IN2COVID: Inhaled Interferon α2b for the Treatment of Coronavirus Disease 19 (COVID-19) (clinicaltrials.gov) - P1/2; N=168; Not yet recruiting; Sponsor: Pontificia Universidad Catolica de Chile

New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6 • PCR

Early Results of BetterLife Preclinical Study Showing AP-003 (rhIFNa2b) has Similar Potent Efficacy Against Different Variants of COVID-19 (GlobeNewswire) - "Early data show potent and similar anti-viral activity against the COVID-19 Wuhan reference strain (EC50=0.51), Alpha (B.1.1.7, UK, EC50=1.26) and Beta (B.1.351, South Africa, EC50=0.25) variants. Further studies are ongoing to validate these early results and to test AP-003 activity against Gamma (Brazil), Delta (India) and Lambda (Peru) variants....An exploratory study in Wuhan, China, in COVID-19 patients, showed that patients treated with inhaled rhIFN⍺2b had a more rapid rate of viral clearance than patients in the comparator arm who did not receive inhaled rhIFN⍺2b....BetterLife has entered into a clinical research agreement with the Pontificia Universidad Católica de Chile to conduct a randomized placebo-controlled trial in COVID-19 patients to test the Company’s proprietary inhaled AP-003."

Licensing / partnership • Preclinical • Infectious Disease • Novel Coronavirus Disease

BetterLife Selects CRO to Conduct Clinical Trials for AP-003 in COVID-19 Cases in Indonesia (GlobeNewswire) - "BetterLife Pharma Inc....has engaged Equilab International to manage the upcoming clinical trials for its proprietary formulation of Interferon alpha2b (AP-003) in mild to moderate cases of COVID-19....BetterLife and Equilab will conduct the placebo-controlled blinded trials in COVID-19 patients at Equilab’s own 75 bed clinical facility."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

BetterLife Provides Shareholder Update and 2021 Product Development Roadmap (GlobeNewswire) - "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...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."

IND • New trial • Preclinical • Infectious Disease • Novel Coronavirus Disease

Pre-IND Discussion with U.S. FDA Helps BetterLife Set Up AP-003 Clinical Trials in Australia (GlobeNewswire) - "BetterLife Pharma Inc....today announced a clinical and regulatory update for its AP-003 COVID-19 clinical trials following discussions with the U.S Food and Drug Administration (FDA)....'The FDA identified and suggested one additional nonclinical study, which is scheduled to begin in the next months'....'BetterLife plans an additional pre-IND interaction with FDA prior to submitting the IND in the U.S. to discuss the data from the nonclinical study'....The AP-003 trial [sic] is a multicenter randomized placebo-controlled trial that will enroll 150 patients with COVID-19 with mild to moderate symptoms....The trial will be conducted in 10 sites in Australia....The primary endpoints will be improvement in patient function over 14 days and improvement in blood oxygenation."

FDA event • New trial • Preclinical • Infectious Disease • Novel Coronavirus Disease

BetterLife CEO Highlights Crucial Difference Between the Company’s Interferon Alpha 2b and Other Treatements (GlobeNewswire) - "The Chief Executive Officer for BetterLife Pharma Inc...discuss the key differences between the interferon inhalation formula used by BetterLife against that used successfully by Synairgen PLC....While both AP-003 and interferon beta are hypothesized to bypass the COVID-19 induced interferon production blockade, BetterLife believe that their proprietary inhaled alpha 2b...could be much more effective against the severity and duration of COVID-19 than interferon beta....He also discusses: The recent merger between BetterLife and Altum; Why the Company has chosen Australia to kick off its 150 patient clinical trial; How using virtual monitoring technology will help BetterLife with patient recruitment."

Clinical • Infectious Disease • Novel Coronavirus Disease

BetterLife Pharma Signs eTMF Partner to Help Accelerate AP-003 Clinical Trial Operations (GlobeNewswire) - "BetterLife Pharma Inc....announced today that it has selected Florence Healthcare to provide its electronic Trial Master File (‘eTMF’) for the conduct of the AP-003 trial. The Florence platform will simplify and accelerate forthcoming clinical trial....Remote site access and connectivity is now a priority for companies looking to start trials....The Florence eTMF is connected to an existing network of 8,000 study sites in 27 countries using its Florence eBinders platform as their Electronic Investigator Site File and supports the rapid implementation of new study sites."

Licensing / partnership • Infectious Disease • Novel Coronavirus Disease

BetterLife Names CRO for COVID-19 Clinical Trial in Australia (GlobeNewswire) - "BetterLife Pharma Inc....is pleased to announce that it has engaged the Clinical Research Organisation ('CRO') Pharmaceutical Solutions Ltd. to manage its forthcoming clinical trial for AP-003 targeting mild to moderate cases of COVID-19 at research sites across Australia. The clinical trial, expected to start in late 2020, will compare AP-003, BetterLife’s inhaled recombinant human alpha 2b interferon ('IFN-α2b') to placebo in patients with mild to moderate symptoms of COVID-19....The trial will recruit 150 participants with mild to moderate symptoms of COVID-19."

Licensing / partnership • New trial • Infectious Disease • Novel Coronavirus Disease

BetterLife Announces Closing of Private Placement (GlobeNewswire) - "BetterLife will use the proceeds for working capital purposes and to advance on the AP-003 clinical trial programs of Altum Pharmaceuticals Inc....These trials are planned to begin in the next 6 to 10 weeks....Altum’s therapeutic pipeline consists of 3 products, including AP-003, a patent-pending interferon a2b (IFNa2b) inhalation formulation. Recent studies in China and the UK have provided data that suggest the therapeutic efficacy of interferon-based treatments for COVID-19."

New trial • Infectious Disease • Novel Coronavirus Disease

BetterLife Pharma Provides Update on Proposed Acquisition of Altum and its Regulatory Guidance and Updated Clinical Development Plan (PRNewswire) - "BetterLife Pharma Inc....is pleased to provide an update on the proposed acquisition of Altum Pharmaceuticals Inc. ('Altum') and its upcoming clinical programs....In a broad ranging interaction covering nonclinical, CMC and clinical aspects, the FDA has responded and provided clear and implementable guidance that can lead to a successful IND filing upon completion of one additional nonclinical study....'The FDA also encouraged further interactions as we near the IND filing.'"

Preclinical • Infectious Disease • Novel Coronavirus Disease

BetterLife CEO Discusses Merger, Planned Interferon Treatment Trials and Potential Subsequent FDA Emergency Use Authorization (GlobeNewswire) - "The Chief Executive Officer for BetterLife Pharma Inc....recently joined online portal Proactive for a Q&A which included...interferon inhalation treatment for COVID-19, what the upcoming trials means for BetterLife....In the online interview, Dr. Doroudian discusses: Why BetterLife plans to kick off its 150 patient Phase 2 clinical trials of the company’s COVID-19 therapeutic AP-003; The expectation that the AP-003 Phase 2 trials will be completed in the next three to six months, and subsequent US FDA Emergency Use Authorization."

Live event • New P2 trial • Trial status • Infectious Disease • Novel Coronavirus Disease

Interferon Treatment Trial 'a Major Breakthrough' Against the Pandemic (GlobeNewswire) - "BetterLife is planning to initiate its Phase II study later this summer with its proprietary IFN-a2b formula called AP-003....BetterLife hope that an inhaler...will deliver AP-003 directly to a patient’s lungs in the hope of stimulating immune response. The treatment is aimed at preventing infected patients deteriorating from requiring oxygen to being placed on a ventilator....The company is also aiming to develop a low dose version of AP-003 that may serve as a prophylaxis or prevention treatment....'We look forward to our proposed 150 patient clinical trials using AP-003...'"

New P2 trial • Infectious Disease • Novel Coronavirus Disease