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 for diffuse systemic sclerosis (dSSc)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

Vicore have finalized a 54-subject phase I dose-escalating study with VP01 which established that a 200 mg daily dose has a good safety profile and is the maximum tolerated dose. Vicore have filed an application with MHRA to perform a phase II study to evaluate the effect of a single dose on cold induced vasoconstriction with VP01 in SSc. In addition, an application will be filed in 2019 for a double-blind, placebo-controlled phase II study in IPF. This study will collect information on the safety and efficacy outcomes of VP01 in these patients.

 

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 and dSSc
  • 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