BetterLife Pharma meets with FDA as it seeks potential approval of AP-003 COVID-19 clinical trials

BetterLife Pharma Inc (CSE:BETR) (OTCQB:BETRF) (FRA:NPAT) announced Tuesday a clinical and regulatory update for its AP-003 COVID-19 clinical trials following discussions with the US Food and Drug Administration.  "Due to the critical unmet medical need and rapid nature of COVID-19 development programs, we pursued an early partnering meeting with FDA to identify a mutually agreeable non-clinical and clinical path that could ultimately lead to a pivotal trial,” said CEO Ahmad Doroudian in a statement.  “We are pleased with the outcome of our recent interaction with the FDA, as they provided clear guidance that would result in a successful IND filing and subsequent initiation of clinical trials in the United States following our Australia trials.” READ: BetterLife Pharma to conduct telemedicine coronavirus trials of AP-003 to ease access for patients Doroudian said the agency provided some inputs on the proposed Australia trial, which the company has implemented. “Our aim as a company is FDA approval with or without Emergency Use authorization for our treatment as soon as possible following completion of the trials in Australia,” he said.   BetterLife said the FDA identified and suggested one additional non-clinical study, which is scheduled to begin in the next months, to strengthen the available nonclinical information to highlight the unique pharmacology of AP-003, the formulation of which is exclusive to BetterLife and to which no other company in the world has access. “BetterLife plans an additional pre-IND interaction with FDA prior to submitting the IND in the US to discuss the data from the non-clinical study, clinical trial data from Australia, and to outline the remaining path to a timely application for marketing approval,” Doroudian said. While AP-003 will be initially investigated for efficacy against COVID-19, the company said it believes AP-003 has other potential clinical targets such as prevention and prophylaxis of other viral infections, such as Ebola and those caused by other coronaviruses, which BetterLife intends to consider as supplementary development programs. Furthermore, since interferon treatment is hypothesized to work by ‘awakening’ the immune system and circumventing the interferon resistance of SARS-CoV-2 (the virus which causes COVID-19), the company said it also believes that its AP-003 treatment could be effective in potential SARS-CoV-2 mutations, such as mutations of the spike proteins. Planned clinical study design BetterLife said the AP-003 trial is a multicenter randomized placebo-controlled trial that will enroll 150 patients with COVID-19 with mild to moderate symptoms to hasten recovery and thus prevent disease progression. Inhaled dosing allows the delivery of AP-003 directly to the lung tissue most at risk from the coronavirus. The trial will be conducted at 10 sites in Australia. Patients will be randomized to receive inhaled AP-003 plus standard of care or placebo plus standard of care. The primary endpoints will be an improvement in patient function over 14 days and an improvement in blood oxygenation. Secondary endpoints will include clinical deterioration and hospitalizations, changes in vital signs including blood oxygenation as measured by pulse oximetry, changes in COVID symptoms such as dyspnea, and changes in levels of cytokines. Contact the author: patrick@proactiveinvestors.com Follow him on Twitter @PatrickMGraham