Vicore Pharma Holding Ab · OMXSTO:VICO
Vicore Pharma Holding Ab — ATTRACT webinar, 8 December 2020
27 slides from Vicore Pharma Holding Ab's conference presentation, Dec 8, 2020
Slide 1: Vicore Pharma AB: C21 in COVID-19, December 2020
VICORE PHARMA AB C21 in COVID 19, December 2020
Slide 2: Forward looking statement
Forward looking statement This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Vicore Pharma’s business, financial
Slide 3: C21 COVID-19 Study: Top line data
C21 COVID-19 STUDY Top line Adata first in class drug, stimulating the body's repair system, reducing tissue damage and promoting healing 3
Slide 4: Study design
STUDY DESIGN A randomized, double-blind, placebo-controlled trial investigating the safety and efficacy of C21 in COVID-19 C21 100 mg BID + SoC for 7 days n=51 Follow-up Screening Randomization Placebo BID + SoC for 7 days 7-10 days n=55 • Key inclusion criteria were hospitalization and severe infla
Slide 5: Top line data - I
TOP LINE DATA - I Demographics • The treatment groups were well balanced regarding age and sex • The treatment groups were well balanced regarding oxygen treatment at baseline • The vast majority of patients (>100/106) patients received corticosteroid treatment The demographics suggest balanced stud
Slide 6: Top line data - II
TOP LINE DATA - II Reduced need of oxygen at the end of the treatment period • In the C21 group, 14/51 patients received oxygen therapy at the end of the treatment period compared to 25/55 in the placebo group • This corresponds to a reduced risk of needing oxygen by 40%, which is statistically sign
Slide 7: Reduced need of oxygen
REDUCED NEED OF OXYGEN Risk of being on oxygen at day 7 50 40 45 40% reduced 30 risk with C21 p=0.057 20 27 10 Placebo C21 The risk of needing oxygen at the end of treatment is reduced by 40% 7
Slide 8: Statistics
STATISTICS In a phase II proof of concept study with 80% power the definition of statistical significance is a p-value < 0.1 False True p=0.1 ATTRACT p=0.05 The data in favor of C21 is statistically significant, well within the 10%-level as predefined in the Statistical Analysis Plan The reduced nee
Slide 9: Top line data - III
TOP LINE DATA - III CRP, TNFα, IL-6 were similar in both groups, which is expected due to the corticosteroid use • Corticosteroids became standard of care in July, just when we started to enroll patients • Corticosteroids are well known to reduce CRP, TNF and IL-6 induced by infection C21 was well t
Slide 10: COVID-19
COVID-19 A first A pandemic in class with drug, stimulating a different profile the body's repair system, reducing tissue damage and promoting healing 10
Slide 11: COVID-19
COVID-19 COVID-19 is a SARS-CoV-2 respiratory infection • It primarily affects the upper airways • Dry cough and fever are the main initial symptoms • After a few days, some patients deteriorate rapidly – the tipping point • The disease changes from an upper respiratory tract infection to involve th
Slide 12: COVID-19 - The disease
COVID-19 - THE DISEASE Upper airways URTI Common cold Alveolar infection Tipping Alveolar type II cells Large surface area point Impaired oxygenation Systemic disease ARDS Intravascular coagulopathy Multiorgan failure SARS-COV-2 in the alveoli results in the impairment in oxygen saturation 12
Slide 13: SARS-CoV-2 pneumonia
SARS-CoV-2 PNEUMONIA The larger surface area involved in the SARS-CoV-2 infection compared to broncho-pneumonia (bacterial or influenza) is due to the specific engagement of alveolar pneumocytes type II Diffuse alveolar disease in coronavirus Bronchopneumonia The large surface area explains the rapi
Slide 14: Pulmonary intravascular coagulopathy
PULMONARY INTRAVASCULAR COAGULOPATHY Scheme showing extensive COVID-19 lung involvement with large anatomical interface between infected type II pneumocytes, leading to extrinsic inflammation with immunothrombosis The diffuse alveolar infection triggers the intravascular coagulopathy 14
Slide 15: Summary
SUMMARY The infection of alveolar pneumocytes type II is what makes COVID-19 a fatal disease and differentiates it from an ordinary coronavirus infection The diffuse alveolar infection results in impaired gas exchange A sudden engagement of a large surface area is the background for the clinical “ti
Slide 16: RAS in COVID-19: AT2R in COVID-19
RAS IN COVID-19 A first in class drug, stimulating the body's repair AT2R in COVID-19 system, reducing tissue damage and promoting healing 16
Slide 17: AT2R & ACE2 cellular expression in human lung
AT2R & ACE2 CELLULAR EXPRESSION IN HUMAN LUNG AT2R ACE2 AT2R, but not ACE2, is specifically expressed in type II pneumocytes 17
Slide 18: Clinical development
CLINICAL DEVELOPMENT ProgressAtofirst in class pivotal drug,2/3 phase stimulating trial the body's repair system, reducing tissue damage and promoting healing 18
Slide 19: Clinical development plan in COVID-19
CLINICAL DEVELOPMENT PLAN IN COVID-19 Proof-of-Concept in patients hospitalized due to COVID-19 gives possibility to: Phase 2 trial Follow-up • Progress to pivotal study in moderate to Hospital use severe disease • Study C21 in outpatient use Phase 2/3 trial Hospital use • Follow-up of patients part
Slide 20: COVID-19 phase 2 follow-up
COVID-19 PHASE 2 FOLLOW-UP Non-interventional, retrospective study evaluating the effect of C21 on lung fibrosis in subjects enrolled in the VP-C21-006 trial COVID-19 Extended follow-up Phase 2 trial 24 weeks • Lung pathology will be assessed by high-resolution computed tomography (HRCT) which was p
Slide 21: COVID-19 phase 2/3 study design
COVID-19 PHASE 2/3 STUDY DESIGN A randomized, double-blind, placebo-controlled trial investigating the safety and efficacy of C21 in COVID-19 C21 100 mg BID + SoC for 14 days n=350-500 Follow-up Screening Randomization Placebo BID + SoC for 14 days 14 days n=350-500 • Key inclusion criteria: hospita
Slide 22: Competitors
COMPETITORS A firstand Competitors in class datadrug, stimulating the body's repair system, reducing tissue damage and promoting healing 22
Slide 23: Competitors
COMPETITORS MoA Route of Results Comments administration LY-CoV555 Neutralizing i.v. infusion Trend for slightly lower FED buys for Lilly antibody severity. $812M Trend for reduced viral ($1250-3120 load. per dose) SNG001 IFN1β Nebulized daily Increased recovery. Synairgen inhalation Saccovid CD24Fc
Slide 24: Market: Place in therapy
MARKET Place in A first in class drug, stimulating the body's repair therapy system, reducing tissue damage and promoting healing 24
Slide 25: Positioning
POSITIONING “Outpatient treatments for COVID-19, coupled with an effective vaccine, would have significant implications for the ability to end this pandemic.” Kim, Read, Fauci, JAMA, December 1, 2020 C21 is an oral treatment which is well tolerated and with a favorable safety profile, that in an out
Slide 26: Summary: C21 and AT2R in disease
SUMMARY C21 and AAT2R first in in class drug, stimulating the body's repair disease system, reducing tissue damage and promoting healing 26
Slide 27: Summary
SUMMARY C21 demonstrates significant clinical efficacy without safety concerns in a phase II pilot study in COVID-19 • The result merits further development with a pivotal trial This is the first time an AT2R agonist shows benefit in human disease • Strengthening the rationale for C21 in IPF Vicore