Our development pipeline

We are leaders in the search to find revolutionary treatments for  severe lung disorders and are rapidly progressing four drug development programs, VP01 (C21), VP02 (Thalidomide),VP03 (new AT2R agonists) and VP04 (Digital Therapeutics). At present, these are experimental unlicensed medicines and we are unable to offer the medicines outside any research setting until we have fully evaluated the benefits and risks.

The VP01 program

C21 (VP01 program) is a small molecule compound for oral administration, which is in clinical development for the treatment of IPF and COVID-19. The experimental programme will assess the potential of C21 for addressing fibrosis, inflammation and vasculopathy in a variety of diseases such as IPF.  

 

Preclinical studies

Preclinical studies carried out with C21 have shown encouraging results in terms of its effects on fibrosis and pulmonary hypertension (PH).

https://vicorepharma.com/wp-content/uploads/2021/03/experimental-pulmonary-fibrosis.jpg Treatment with C21 reverses fibrosis in bleomycin model (adapted from Rathinasabapathy et al. 2018)

Clinical studies

Phase II study in Idiopathic Pulmonary Fibrosis (AIR)  

The main purpose of this therapeutic exploratory study is to investigate the safety and efficacy of C21 in treatment-naïve patients with IPF and to provide a clear go/no go for confirmatory phase.

The AIR study was designed in collaboration with international clinical experts in IPF and is focused on the patient’s needs and preferences, e.g., all patients receive active treatment. It is an open-label, single-arm study in which C21 is given orally twice daily as monotherapy for 24 weeks with an option to continue treatment for another 12 weeks. Patients with IPF have a well-characterized decline in lung function. Effect of C21 on lung function, measured by change from baseline in forced vital capacity (FVC), will be investigated and interpreted in the light of the well-documented natural history of IPF.

The study has multiple centers with regulatory approvals obtained in the UK, India, Ukraine and Russia. The first patient was recruited in November 2020 and the study is estimated to read-out in Q4, 2022.

Phase II study in IPF (AIR)

Phase III study in COVID-19 (ATTRACT-3)

The main purpose of ATTRACT-3 in which C21 is tested for the treatment of COVID-19 with the objective of generating key efficacy and safety data for assessment by regulatory bodies, including the US FDA. The study is ongoing and the first patients where dosed in September. 

ATTRACT-3 is a randomized, double-blind, placebo-controlled, multinational, phase 3 trial which will include 600 adult patients hospitalized with COVID-19 requiring oxygen support but not mechanical ventilation. The primary objective is to evaluate the effect of C21 on recovery from COVID-19.

For more information about the study; ATTRACT-3 on Clinicaltrials.gov

Phase II study in COVID-19 (ATTRACT) and long-term follow-up (ATTRACT-2)   

The main purpose of this therapeutic exploratory study was to investigate if C21, through stimulation of AT2R, could improve the clinical outcome in patients hospitalized with COVID-19. The study included adult patients with confirmed SARS-CoV-2 infection and signs of acute respiratory infection, but not requiring invasive or non-invasive mechanical ventilation.

ATTRACT was a randomized, double-blind, placebo-controlled, parallel-group, multicenter study performed on top of standard-of-care. C21 was given orally, twice daily for 7 days and the patients were followed for 14 days. The study was initiated in July 2020 and completed in September 2020. The results were publicly shared in December 2020.

For more information about the background and the results from the ATTRACT study 

Phase II study in COVID-19 (ATTRACT)

 

Phase II mechanistic study in systemic sclerosis 

The main purpose of this mechanistic study was to examine the role of the AT2R in acute improvement of blood flow in fibrotic tissues and thus demonstrate proof-of-mechanism with regards to the proposed vasodilatory effects of C21. This effect may benefit patients with SSc-related pulmonary fibrosis as well as patients with other interstitial lung diseases such as IPF.

This was as a randomized, double-blind, placebo-controlled, single-dose study utilizing a cross-over design to control for inter-individual variability in response to cold challenge. The study was initiated in December 2019 and completed in December 2020. The results were publicly shared in March 2021.

For more information about the background and the results from the SSc study

Phase II mechanistic study in SSc  

Orphan drug designation

C21 has been recognized as an orphan drug in IPF by the regulatory authorities in Europe and the USA. This means that it will have market exclusivity for 10 years in the EU after its authorization and 7 years in the USA. The regulatory authorities will also provide us with valuable scientific advice on the design of future clinical trials.

 

C21: summary

  • First-in-class orally administered angiotensin II type 2 receptor (AT2R) agonist
  • Potent and highly selective >5,000x differential affinity AT2R versus AT1R
  • Vascular and anti-fibrotic effects and no GI effects
  • In development for the treatment of IPF and COVID-19
  • Could be targeted for many disorders, given the dual vascular and healing potential benefits
  • Orphan drug designation in EU/US

 

The VP02 program

The VP02 program focuses on an experimental novel formulation and delivery route for Thalidomide, an existing immunomodolutary drug (IMiD), to provide a new treatment option for patients with IPF and IPF-related cough.  It is thought that the actions of Thalidomide suppress pathways involved in the cough reflex together with disease modifying antifibrotic effects. IMiDs have documented antifibrotic and anti-inflammatory properties and may therefore be well suited for treatment of a number of interstitial lung diseases. Vicore’s VP02 program aims to eliminate the negative aspects of systemic Thalidomide exposure by developing VP02 for local administration to the lungs.

Development of VP02

Preclinical antifibrosis studies have shown encouraging results. In animal studies, VP02 has been shown to inhibit the production of pro-inflammatory profibrotic cytokines, reduce angiogenesis, inhibit collagen deposition in the lung, reduce pathological changes in lung tissue, and decrease oxidative stress and inflammation.

In addition, the active ingredient has been shown in the clinic to reduce the severe, persistent dry cough that is associated with IPF (Horton et al, Ann Intern Med 157:398-406, 2012). This is a unique feature, which Vicore believes will likely have a pronounced effect on IPF patients’ quality of life.

Part of the VP02 program includes development of novel formulations designed to deliver active compound directly to the lung through inhalation. This method of delivery may help to maximize drug absorption while potentially minimizing any effects on the rest of the body.

 

VP02 summary

  • In development for treatment of IPF cough and IPF
  • Thalidomide has shown early clinical evidence against the severe, persistent dry cough of IPF
  • Expected to have a positive effect on quality of life
https://vicorepharma.com/wp-content/uploads/2021/01/vp02-improves-ipf-cough.png Oral thalidomide for 3 months significantly improves IPF cough and quality of life.

The VP03 programme

Within this program, Vicore develops new patentable chemical entities targeting the AT2R. The objective is to develop competitive pharmaceutical products also for broader indications where it is not possible to obtain orphan drug status.

In October, Vicore strengthened its portfolio of new chemical entities for the VP03 programme by acquiring intellectual property rights (IPR) of a series of novel AT2R agonists from HaLaCore Pharma.

The VP03 program, which is in the preclinical phase, has developed well. The development work is done in collaboration with Emeriti Bio and HaLaCore Pharma. The aim is to have a candidate drug by the end of 2021 and start a phase I study during the first half of 2022.

The VP04 programme

The VP04-programme develops a prescription digital therapeutic (DTx) based on cognitive behavioral therapy (CBT) to treat the depression and anxiety associated with IPF.

Development of VP04

Vicore collaborates with Alex Therapeutics, a medtech company specializing in designing and developing Software-as-a-Medical-Device (SaMD) with expertise in technology and psychology, for the technical development.

 

Digital Therapeutics

Digital therapeutics (DTx) refers to digital products which deliver an evidence-based clinical intervention. In recent years, interest in using software to treat various conditions has increased greatly, largely thanks to 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. Apart from its effectiveness, some major benefits of DTx are the scalability and targeted capabilities for personalizing,  making it simpler than ever to give the opportunity of improved health to a large number of people. As interest in DTx from the healthcare sector and patients has grown, EU authorities have responded by evolving assessment frameworks, ensuring that any DTx that makes it to market is safe and effective.