Interim report January - March 2020

Gothenburg, May 5, 2020 - Vicore Pharma Holding AB (publ) publishes the interim report for the first quarter 2020. 

 Important events during the first quarter

• In January, Vicore issued 243,525 shares to the warrant holders in the incentive programme LTIP 2016.
• In the beginning of 2020, the phase II study with C21 in patients with systemic sclerosis (SSc) and Raynaud's phenomenon dosed its first patients.
• In March, Vicore submitted a Clinical Trial Application (CTA) to the UK regulatory agency MHRA, for a phase II study with C21 in patients with IPF. The study has been re-designed and extended to six months, compared to the earlier planned three months, in order to increase the probability of documenting a treatment effect. This will be enabled by comparing the development of the patients' lung function with the well documented disease progression in untreated patients. In addition, patients will be given the opportunity to continue treatment for another three months. The study will not include a placebo group.
• In March, Vicore submitted a Letter of Intent (LoI) to file a clinical trial application (CTA) to the UK regulatory agency MHRA, for a phase II study with VP01 in patients with COVID-19.

Important events after the period

• In April, Vicore gained approval from the UK regulatory agency MHRA, to start the phase II study on patients with COVID-19. The study will be a randomized, double blind, placebo controlled study in approximately 100 COVID-19 patients with a moderately severe disease, treated with basic respiratory care, but not on mechanical ventilation. The study will investigate the efficacy on respiratory failure and functional outcomes. The clinical part is estimated to take three months to finalize. Estimated read-out is during 2020.
• In May, Vicore received approval from the UK regulatory agency MHRA, to start the phase II study with VP01 in patients with IPF.

Financial overview for the period

January 1 - March 31, 2020

• Net sales amounted to 0.0 MSEK (0.0)
• The operating loss was -28.8 MSEK (-16.1)
• Loss for the period amounted to -28.4 MSEK (-16.0)
• Loss per share, before and after dilution, was -0.56 SEK (-0.40)

Financial summary of the group

1 There is no dilution effect for potential ordinary shares for periods where earnings have been negative.

CEO comments

During the first four months of 2020, we worked intensively with our three phase II studies within the VP01 project. In tandem, the VP02 project is running according to plan.

The clinical trial application (CTA) for the phase II study in patients with IPF was submitted to the UK regulatory agency, MHRA, at the end of March and the approval was received in May. The study has been designed to give us a strong statistical power. And as it is open label we will have good prerequisites for recruitment since patients are certain to be treated with the active substance. The study will include approximately 60 patients and the observed treatment effect of VP01 for six months will be compared with the well-documented linear decline of lung function in untreated patients. Depending on the COVID-19 situation, we anticipate that patient recruitment can start during the third quarter 2020.
On April 28, we announced approval of the clinical trial application (CTA) from the UK regulatory agency MHRA for a phase II study with VP01 in patients with COVID-19. Thanks to a dedicated in-house team and the efforts of our clinical research organization, Orphan Reach, we managed get the trial through to approval in record time, only four weeks.
 

The study, named ATTRACT (Angiotensin II Type Two Receptor Agonist Covid-19 Trial) is targeting hospitalized patients treated with basic respiratory care, but not on mechanical ventilation. These patients have a marked inflammatory drive which can lead to acute respiratory failure if it progresses.
 

Internal preclinical findings with VP01 suggest that it may have a role in the treatment of COVID-19. The RAS is understood to play a role in the development of COVID-19 as angiotensin II (ANG II) is upregulated and contributes to the inflammatory cascade. Furthermore, the protective arm of the RAS is disarmed by SARS-CoV-2, which binds to the enzyme ACE2 and thereby inhibits the conversion of ANG II to protective molecules stimulating the AT2R. Because VP01 directly stimulates the AT2R, the belief is that it could bypass the way by which a virus like SARS-CoV-2 is capable of incapacitating the RAS. 
 

In the ongoing phase II study in patients with SSc and Raynaud's phenomenon, we are studying if VP01 can increase blood flow in a cold challenge test. Effects on blood flow can be significant even in the lung manifestations in SSc as well as in IPF. The study has recruited patients faster than planned. However, the clinical trial work has been paused due to the situation with COVID-19. We plan to start again this fall, and with a similar recruitment pace the study can be finished before the end of the year, depending on how the pandemic develops.
 

The VP02 program, which concerns the local delivery of an IMiD to the lung for the treatment of IPF and IPF-related cough, is proceeding according to plan. A product candidate that shows promising separation between local and systemic exposure is now being further explored in toxicological studies. The regulatory application in connection with the first clinical study within the VP02 program is planned for late 2020.
 

In summary, we have entered 2020 at a very high pace in our drug development projects and although the COVID situation may slow us down a bit, it also generates new opportunities. Our focus is to create the best possible odds for our drug candidates to reach the market and thereby help severely suffering lung patients.

Carl-Johan Dalsgaard, CEO

For further information, please contact:

Carl-Johan Dalsgaard, VD, tel: +46 70 975 98 63, carl-johan.dalsgaard@vicorepharma.com  

Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com  

This information was submitted for publication on 5 May 2020 at 08:00 CET.