Our development pipeline

We are leaders in the search to find revolutionary treatments for  rare lung disorders and are rapidly progressing two drug development programmes, VP01 and VP02. 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 programme

VP01 is a small molecule compound for oral administration, which is in clinical development for the treatment of interstitial lung diseases (ILDs). The experimental programme will assess the potential of VP01 for treatment of idiopathic pulmonary fibrosis (IPF) and in systemic sclerosis (SSc) where fibrosis/vasculopathy is a significant aspect of the disease process.

Immunomodulatory drugs reduce fibrosis and stop disease progression.

Preclinical studies (including animal models)

Preclinical studies carried out with VP01 have shown encouraging results in terms of its effects on fibrosis and pulmonary hypertension (PH).

Clinical studies

The phase II clinical study with C21 in patients with SSc started to recruit patients in December 2019, and Vicore expects the study to be completed within a year from the start. The study is designed to study the effect of C21 on cold-induced vasoconstriction in patients with SSc. It will shed light on the AT2 receptor’s role in improving blood flow in diseased tissues, an effect that may benefit patients with SSc related pulmonary fibrosis as well as patients with IPF

Vicore have submitted the clinical trial application for a phase II study in IPF. This study will collect information on the safety and efficacy outcomes of VP01 in these patients. The study design has been modified in order to maximize the statistical power to detect a treatment effect, as well as reduce the number of patients needed, hence potentially shortening the time to read-out.

In addition, Vicore has submitted a Letter of Intent (LoI) for a phase II study with C21 in COVID-19. There is a good scientific rationale for studying C21 as a potential treatment of COVID-19. It has recently been shown that the SARS CoV-2 virus utilizes the enzyme ACE2, which is part of RAS, for entry into the cell. This inactivates the ACE2 enzyme, creating an imbalance in the local RAS, leading to acute lung injury. Given that ACE2 generates the natural ligands for AT2R, Vicore Pharma believes that, by acting directly on the AT2R, C21 may suppress inflammatory mediators and bypass the way by which the virus incapacitates the system.

Orphan drug designation

VP01 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.

VP01: summary

  • Can be taken orally
  • In development for the treatment of IPF, pulmonary fibrosis in SSc and COVID-19
  • Could be targeted for many disorders, given the dual vascular and anti-fibrotic potential benefits
  • Has been granted orphan drug designation in IPF

The VP02 programme

VP02 focuses on an experimental novel formulation and delivery route for an existing pharmaceutically-active compound to provide a new treatment option for patients with IPF. VP02 is being investigated for pulmonary sarcoidosis in tandem with studies in IPF

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. This is a unique feature, which Vicore believes will likely have a pronounced effect on IPF patients’ quality of life.

The VP02 development process.

Part of the VP02 programme 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
  • Active compound has shown early clinical evidence against the severe, persistent dry cough of IPF
  • Could have a positive effect on quality of life