Partners to Create Phone App to Improve Mental Health of Patients

Vicore Pharma and Alex Therapeutics are collaborating to develop a new phone app that could help improve the mental health of people with idiopathic pulmonary fibrosis (IPF).

Vicore will own all rights to the new clinical program, called VP04, in exchange for various payments and royalties to Alex.

Living with a chronic condition like IPF is often stressful, scary, and isolating. For this reason, many people with IPF experience clinically relevant anxiety, depression, and other mental health problems.

The overall goal of the new VP04 program is to create a digital therapeutic (i.e., a phone app) that can help people with IPF deal with these mental health challenges by delivering cognitive behavioral therapy (CBT). This is a kind of psychotherapy is designed to train the mind to break out of unhelpful patterns of thoughts or behavior — for example, focusing on things to be grateful for, rather than ruminating on things that cannot be changed.

Normally, CBT is performed during in-person consultations where patients talk with a therapist, psychologist, or similar professional. The aim of VP04 is to use artificial intelligence, rather than a human expert, to personalize the therapy. A notable benefit of this strategy, according to the companies, is that support will be available to patients 24/7.

“The mission, really, is to improve the lives of these patients,” John Drakenberg Renander, CEO of Alex Therapeutics, said in a webinar. “We will develop a fully autonomous and standalone digital therapeutic that can be prescribed by doctors to patients, and focus on the mental health conditions of these patients, for example like anxiety and depression.”

Once developed, the plan is to market VP04 as a certified medical device, meaning that rigorous processes will be needed to demonstrate its safety and effectiveness. The companies hope to secure regulatory approval to start clinical testing of the device next year, after designing the software and the trial to test it.

“The integration of digital therapeutics in healthcare is growing rapidly, and there are already clear regulatory pathways and commercial opportunities that bring validated benefits to patients,” Renander said in a press release.

VP04 expands Vicore’s existing therapeutic programs in IPF and other respiratory diseases, which include three other clinical programs focused on the development of new potential therapies for these disorders.

The most advanced one is assessing the potential of an investigational oral therapy, called VP01 (C21), for IPF and COVID-19. The therapy is in clinical testing, with the first IPF patient enrolled in a proof-of-concept Phase 2 trial (NCT04533022) last year.

“The VP04 program is part of Vicore’s goal of addressing the totality of unmet medical needs in IPF,” said Carl-Johan Dalsgaard, MD, PhD, Vicore’s CEO. “While our highly promising VP01 and VP02 programs target the underlying causes and major physical symptoms of the disease, VP04 will address the psychological impact patients diagnosed with IPF often experience.”