Vicore starts collaboration with Alex Therapeutics to develop new digital therapeutic for patients with IPF

2021-05-04 | Regulatory

The agreement with Alex Therapeutics marks the initiation of a new clinical program for Vicore (VP04) – the joint development and commercialization of a clinically validated digital therapeutic (DTx) will provide cognitive behavioral therapy (CBT) for patients suffering from IPF. Under the agreement, Vicore will own all rights to VP04 in exchange for an upfront payment to Alex Therapeutics of 8.1 MSEK (1 MUSD), plus potential milestone payments and royalties on sales.

VP04 expands Vicore’s existing therapeutic programs in IPF and other severe respiratory diseases. The digital therapeutic will be designed to provide CBT to IPF patients, in parallel to routine consultations with medical professionals, to help improve their quality of life and support them through the psychological impacts of disease and its diagnosis. Working closely with patient groups and healthcare providers, Vicore and Alex Therapeutics expect to begin the clinical trial of VP04 in 2022.

“The VP04 program is part of Vicore’s goal of addressing the totality of unmet medical needs in IPF,” said Carl-Johan Dalsgaard, CEO of Vicore. “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. We are very pleased to work with an experienced co-development partner like Alex Therapeutics to advance the clinical validation of VP04 and bring therapeutic solutions to IPF patients that address several dimensions of their disease.”

To drive the VP04 program, Vicore has recently recruited Jessica Shull as Head of Digital Therapeutics. She brings more than 20 years’ experience in the development and adoption of digital healthcare technologies and has provided expertise on digital health best practices and policy for the WHO and the Digital Therapeutics Alliance.

The partnership will utilize Alex Therapeutics’ validated AI-powered digital therapeutics platform “Alex DTx Platform”. The platform combines evidence-based methods such as CBT with AI and is used to develop personalized treatments to cover unmet needs among patients worldwide.

“Vicore’s deep expertise in IPF and other severe lung diseases is highly complementary to our experience and technology” said John Drakenberg Renander, CEO of Alex Therapeutics. “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.”

Webinar presentation
Vicore will host a webcast to present more about the VP04 program at 15.00 CET (9 am EST) today that can be accessed via the link: https://financialhearings.com/event/13868  

The presentation will be available before the webcast at: https://vicorepharma.com/investors/events-presentations/

For further information, please contact:

Vicore Pharma Holding AB
Carl-Johan Dalsgaard, CEO
Tel: +46 70 975 98 63
E: carl-johan.dalsgaard@vicorepharma.com  

Alex Therapeutics AB
John Drakenberg Renander, CEO
Tel: +46 70 883 00 35
E: john@alextherapeutics.com

This information is such that Vicore Pharma Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above on May 4, 2021 at 08:00 CEST.

About Vicore Pharma Holding AB (publ)

Vicore Pharma is a rare disease pharmaceutical company focused on fibrotic lung disease and related indications. The company currently has four development programs, VP01, VP02, VP03 and VP04. VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (IPF) and COVID-19. VP02 is based on a new formulation and delivery route of thalidomide and focuses on the underlying disease and the severe cough associated with IPF. VP03 includes the development of new AT2R agonists. VP04 develops a clinically validated digital therapeutic for IPF patients.?

The company's shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.

About Alex Therapeutics AB

Alex Therapeutics is a medtech company based in Stockholm which designs and develops Software-as-a-Medical-Device (SaMD). With the proven “Alex DTx Platform”, expertise in artificial intelligence and evidence-based psychology, Alex Therapeutics is uniquely positioned to deliver cutting-edge and reliable DTx products that demonstrably improve the health of patients. Alex Therapeutics has developed a prescription digital therapeutic for Nicotine Addiction and is trusted by big pharma partners. The company has served tens of thousands of patients, has experience in clinical validation, and positive patient testimonials.  For more information, see www.alextherapeutics.com.

About IPF

Patients diagnosed with IPF have a life expectancy of 3-5 years, during which their symptoms of severe shortness of breath, fatigue, and cough only worsen. Currently there are limited treatment options for IPF, even for symptomatic relief. The need to plan daily routines around the debilitating respiratory symptoms of IPF deepens anxiety and depression, particularly in patients experiencing a noticeable exacerbation in physical symptoms.

About Digital Therapeutics

Digital therapeutics (DTx) are clinically proven medical treatments delivered digitally to patients. In recent years, interest in using software to treat various conditions has increased greatly, with a growing body of scientific literature documenting the effectiveness of DTx. They can be used either as standalone treatments or together with medication or other devices, are highly scalable and readily personalized. As interest in DTx from pharmaceutical companies and medical professionals has grown, authorities in Europe and elsewhere have developed new assessment frameworks, requiring that digital therapeutics are shown to be clinically safe and effective before regulatory approval.