As Pfizer plans to lean in on producing its COVID-19 antiviral this year—boosting the number of available Paxlovid treatments by 50% to more than 3.6 billion doses by the end of 2022—the drugmaker is looking to pick up the developer of a diagnostic smartphone app, which could help get tablets into patients’ hands faster.
The Australia-based ResApp Health uses machine learning algorithms to analyze recordings of a person’s coughs and breathing sounds to determine the extent of a wide range of respiratory diseases including pneumonia, asthma, bronchitis and chronic obstructive pulmonary disease, or COPD.
Pfizer, through its Australian subsidiary, has proposed a deal to acquire the company for about A$100 million, or about $74.2 million U.S. in cash—in addition to signing a separate agreement to work with ResApp to develop its app to catch cases of COVID-19.
That non-exclusive R&D collaboration carries a A$3 million upfront fee for Pfizer to license ResApp’s technology, plus up to A$1 million in milestones based on future recruitment of patients into clinical trials to test out the app. The question of proceeding with the acquisition in full will be voted on by ResApp shareholders in mid-June, the company said in a release (PDF).
ResApp’s program, dubbed ResAppDx, has received a CE Mark for use in Europe and has been approved by Australia’s Therapeutic Goods Administration. The company says it can gather clearer data from a cough, which is a result of air moving from the lungs up the airway into the open, compared to what a doctor can gather from listening with a stethoscope, which can be muffled by the bones and muscles in the chest.
In late March, the company announced that its smartphone-based method could detect cases of COVID-19 with a false-negative rate of about 8%.
A pilot study of 741 patients in the U.S. and India, including 446 who tested positive for COVID-19, showed the app could screen people with an accuracy that rivals rapid antigen tests, according to ResApp. The company also tested the new algorithm against cough recordings collected prior to the pandemic, resulting in a false-positive rate of less than 10%.
“The sheer scale of this global pandemic and the likely evolution to an endemic disease means we need more scalable diagnostic tools that can balance our current over-reliance on rapid antigen and PCR tests,” said Catherine Bennett, chair of epidemiology at Australia’s Deakin University and a member of ResApp’s COVID-19 scientific advisory board.
ResApp currently has three clinical trials recruiting patients in the U.S. and India to collect cough sounds, symptoms and PCR test results. The studies are also comparing measures of viral load to evaluate the algorithm’s sensitivity among different cases.
Pfizer, meanwhile, received a provisional TGA approval (PDF) in Australia for its Paxlovid tablet in January, after collecting an emergency green light from the FDA the month before. The oral antiviral includes nirmatrelvir, designed to disrupt the coronavirus’ ability to replicate and spread. In Australia and the U.S., it can be prescribed in the days after symptoms appear to help patients avoid severe illness.
Also at the top of the year, during the J.P. Morgan Healthcare Conference, Pfizer CEO Albert Bourla outlined plans to significantly expand the company’s capacity to produce Paxlovid.
After first projecting last November that it would produce about 50 million courses of the treatment this year, that number grew to 80 million. But then Bourla announced in January that Pfizer would shoot for 120 million treatments by the end of 2022, with 90 million coming in the latter half of the year alone.
At the same time, the company aims to further expand its production for the years ahead, as Paxlovid tablets are easier to produce than liquid vaccine doses. The drug also has a shelf life of about three years, and several countries have shown interest in stockpiling the treatment, Bourla said.
In the U.S., the Biden administration earlier this year outlined a plan to launch “test and treat” locations that pair rapid test results with immediate antiviral treatments—in settings such as pharmacy clinics, community healthcare centers, long-term care facilities and veterans’ health centers—after inking a massive $5.3 billion supply deal for Pfizer’s Paxlovid last November.