BODY TEMPERATURE NORMALIZATION
The median time to normalization of body temperature (<37 degrees of Celcius) was 2 days on AVIFAVIR and 4 days on Standard of Care (p = 0.007).
The median time to normalization of body temperature (<37 degrees of Celcius) was 2 days on AVIFAVIR and 4 days on Standard of Care (p = 0.007).
Avifavir® is the first effective drug for COVID-19
treatment registered in Russia
AVIGAN (Favipiravir) Tablets 200mg
ORIGINALLY DEVELOPED by Toyama Chemical Co., Ltd. (FUJIFILM Corporation)
REGISTERED in Japan in 2014 for treating resistant strains of influenza novel or re -emerging influenza virus infections
February 2020: Preliminary APPROVED IN CHINA for treatment of patients with COVID -19 in critical condition
May 2020: APPROVED IN RUSSIA for treatment of patients with moderate to severe COVID -19
June 2020: Preliminary APPROVED IN INDIA for treatment of patients with mild to moderate COVID -19
ORIGINALLY DEVELOPED by Toyama Chemical Co., Ltd. (FUJIFILM Corporation)
REGISTERED in Japan in 2014 for treating resistant strains of influenza novel or re -emerging influenza virus infections
February 2020: Preliminary APPROVED IN CHINA for treatment of patients with COVID -19 in critical condition
May 2020: APPROVED IN RUSSIA for treatment of patients with moderate to severe COVID -19
June 2020: Preliminary APPROVED IN INDIA for treatment of patients with mild to moderate COVID -19
RDIF and ChemRar Group launch JV for production of antiviral drug AVIFAVIR®
Press release, 26.03.2020
The drug has been used successfully in China to cure coronavirus patients
Moscow, March 26, 2020: The Supervisory Board of the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, has approved the creation of a Joint Venture (JV) withChemRar Group aimed at the production of Avifavir and other related innovative antiviral medicines.
On March17th Zhang Xinmin, head of China’s National Center for Biotechnology Development,told the media of Favipiravir’s effectiveness against coronavirus, as provedby clinical studies held in Wuhan and Shenzhen .
Patients treated with Favipiravir tested negative for coronavirus in four days, whereas for those not receiving the drug it took 11 days to do so.
Zhang updated reporters that in 91% of the treated group the conditions of their lungs improved, compared with 62% of those in the control group.
Favipiravir is an antiviral drug created in Japan that was approved for marketing in 2014.
The drug has been used successfully in China to cure coronavirus patients
Moscow, March 26, 2020: The Supervisory Board of the Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, has approved the creation of a Joint Venture (JV) withChemRar Group aimed at the production of Avifavir and other related innovative antiviral medicines.
On March17th Zhang Xinmin, head of China’s National Center for Biotechnology Development,told the media of Favipiravir’s effectiveness against coronavirus, as provedby clinical studies held in Wuhan and Shenzhen .
Patients treated with Favipiravir tested negative for coronavirus in four days, whereas for those not receiving the drug it took 11 days to do so.
Zhang updated reporters that in 91% of the treated group the conditions of their lungs improved, compared with 62% of those in the control group.
Favipiravir is an antiviral drug created in Japan that was approved for marketing in 2014.
AVIFAVIR®, CURRENT PROJECT STATUS
CLINICAL STUDY DESIGN
COVID -FPR-01 « An adaptive, multicenter, randomized, open-label, comparative clinical trial to assess efficacy and safety of AVIFAVIR in patients hospitalized with COVID-19»
Arm 1
AVIFAVIR
AVIFAVIR
1 600mg BID (day 1)
600mg BID (days 2 -14)
600mg BID (days 2 -14)
Arm 2
AVIFAVIR
AVIFAVIR
1 800mg BID (day 1)
800mg BID (days 2 -14)
800mg BID (days 2 -14)
Arm 3
Standard of Care
Standard of Care
Treatment based on Russian regulatory recommendations and PI’s decision
Dose selection
IDMC
IDMC
Interim analysis at Stage 1
- Proportion of patients with viral clearance on Day 10 and Day 5
Study primary objectives at Stage 2
- Time to viral clearance
- Time to clinical improvement based on WHO Ordinal scale
Study assessments:
- PCR at baseline and on Days 3, 5, 7, 9, 11, and 15
- Vital signs and SpO2 daily
- CT at baseline and on Day 15, Day 22, and Day 29
- CRP, safety labs, and ECG at baseline and on Day 5 and Day 15
- Survival follow -up on Day 29
- Proportion of patients with viral clearance on Day 10 and Day 5
Study primary objectives at Stage 2
- Time to viral clearance
- Time to clinical improvement based on WHO Ordinal scale
Study assessments:
- PCR at baseline and on Days 3, 5, 7, 9, 11, and 15
- Vital signs and SpO2 daily
- CT at baseline and on Day 15, Day 22, and Day 29
- CRP, safety labs, and ECG at baseline and on Day 5 and Day 15
- Survival follow -up on Day 29
CLINICAL STUDY POPULATION
Main inclusion criteria
- Hospitalized patients with confirmed COVID-19 (PCR+)
- Moderate to severe condition (Grade 3-4 on WHO scale)
Main exclusion criteria
- Acute respiratory distress (SpO 2 < 90%, RR > 35 per minute, etc.)
- Previous ethiotropic treatment (HCQ, LPR/r, etc.)
- Terminal stages of liver and renal diseases, HIV
- Unable to take study drug per os
- Hospitalized patients with confirmed COVID-19 (PCR+)
- Moderate to severe condition (Grade 3-4 on WHO scale)
Main exclusion criteria
- Acute respiratory distress (SpO 2 < 90%, RR > 35 per minute, etc.)
- Previous ethiotropic treatment (HCQ, LPR/r, etc.)
- Terminal stages of liver and renal diseases, HIV
- Unable to take study drug per os
PROOF OF CONCEPT
0 1 2 3 4 5 6 7 8 9 10
0
25
50
75
100
TIME TO NORMAL BODY TEMPERATURE (<37 degrees of Celcius)
PROPOTION OF PATIENCES (%)
AFIVAVIR (N=40)
SOC (N=20)
VIRAL RNA ELIMINATION (PCR TEST)
Confirmed PCR( -) result 4 days after the treatment initiation was obtained in 25/40 (62.5%) patients on AVIFAVIR and in 6/20 (30.0%) patients on Standard of Care (p=0.018)
Confirmed PCR( -) result 4 days after the treatment initiation was obtained in 25/40 (62.5%) patients on AVIFAVIR and in 6/20 (30.0%) patients on Standard of Care (p=0.018)
PROPOTION OF PATIENCES (%)
100
75
50
25
0
Day 5
Day 10
ELIMINATION OF SARS-CoV-2 BY STUDY DAY
p-value = 0.018
p-value = 0.021
62.5%
30%
90%
80%
Part I
IDMC Conclusions:
- Proof -of-concept confirmed
- Rapid antiviral response within 4 days in 62.5% patients on AVIFAVIR vs. 30% patients on Standard of care (p=0.018)
- Dose selected (three dose ranges based on weight)
- Treatment duration up to 10 days (or till confirmed PCR-)
- The drug was well tolerated and had no safety issues. Mild to moderate adverse drug reactions were reported in 7/40
(17.5%) patients, including diarrhea, nausea, vomiting, chest pain and an increased ALT and AST
- AVIFAVIR® approved by Russian regulatory authorities
Part II
Study ongoing
Final CSR is expected EO Q4 2020
IDMC Conclusions:
- Proof -of-concept confirmed
- Rapid antiviral response within 4 days in 62.5% patients on AVIFAVIR vs. 30% patients on Standard of care (p=0.018)
- Dose selected (three dose ranges based on weight)
- Treatment duration up to 10 days (or till confirmed PCR-)
- The drug was well tolerated and had no safety issues. Mild to moderate adverse drug reactions were reported in 7/40
(17.5%) patients, including diarrhea, nausea, vomiting, chest pain and an increased ALT and AST
- AVIFAVIR® approved by Russian regulatory authorities
Part II
Study ongoing
Final CSR is expected EO Q4 2020
0.0
0.2
0.5
0.7
0.9
PROPOTION OF PATIENCES (%)
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
STANDARD
AFIVAVIR
CLINICAL STUDY: PART 2 - VIRAL ELIMINATION
INTERIM RESULTS
Population: MITT population. Patients without respiratory failure (WHO Category 3, no oxygen therapy)
Population: MITT population. Patients without respiratory failure (WHO Category 3, no oxygen therapy)
Time to SARS-CoV-2 RNA elimination
DAYS
Statistically significant advantage (4.5 vs 6.5 days) in time to viral elimination in Avifavir® cohort
Higher efficacy comparing standard in mild to moderate COVID-19 infected patient
Higher efficacy comparing standard in mild to moderate COVID-19 infected patient
COHORT |
N |
AUC |
MEDIAN |
RANGE |
p-VALUE |
AFIVAVIR |
71 |
5,7 |
4,5 |
3,5 - 8,0 |
0,03 |
STANDARD |
58 |
7,3 |
6,5 |
4,0 - 10,0 |
|
CLINICAL STUDY: PART 2 - FEVER NORMALIZATION
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
0.0
0.2
0.5
0.7
0.9
PERCENT OF
DAYS
STANDARD
AFIVAVIR
COHORT |
N |
AUC |
MEDIAN |
RANGE |
p-VALUE |
AFIVAVIR |
55 |
2,5 |
2,0 |
1,0 - 3,5 |
0,01 |
STANDARD |
42 |
3,6 |
3,5 |
1,0 - 5,0 |
|
INTERIM RESULTS
Population: MITT population. Patients without respiratory failure (WHO Category 3, no oxygen therapy)
Population: MITT population. Patients without respiratory failure (WHO Category 3, no oxygen therapy)
Time to body temperature normalization (<37oC / <98.6F)
Statistically significant advantage (2 vs 3.5 days) in time to body temperature normalization
Higher efficacy comparing standard in mild to moderate COVID-19 infected patient
Higher efficacy comparing standard in mild to moderate COVID-19 infected patient
AVIFAVIR® : RECOMMENDED DOSING REGIMEN
Dosing regimen selected by IDMC and recommended by MoHof Russia*
For patients weighing less than 75 kg: 1 600 mg BID on Day 1 and 600 mg BID on Days 2-10
For patients weighing 75 - 90 kg (inclusive): 2 000 mg BID on Day 1 and 800 mg BID on Days 2-10
For patients weighing more than 90 kg: 2 400 mg BID on Day 1 and 1000 mg BID on Days 2-10
*excerpt from Temporary recommendations for prophylaxis, treatment and diagnostics of novel COVID-19 infection v.7 issued by Ministry of Health of Russia
For patients weighing less than 75 kg: 1 600 mg BID on Day 1 and 600 mg BID on Days 2-10
For patients weighing 75 - 90 kg (inclusive): 2 000 mg BID on Day 1 and 800 mg BID on Days 2-10
For patients weighing more than 90 kg: 2 400 mg BID on Day 1 and 1000 mg BID on Days 2-10
*excerpt from Temporary recommendations for prophylaxis, treatment and diagnostics of novel COVID-19 infection v.7 issued by Ministry of Health of Russia
BE INFORMED,
Areplivir (Ministry of Health)
Areplivir Registration Certificate
Favirapir Review A'
Areplivir Conclusion to Interim Report
Favirapir Review B'
Favirapir and COVID-19 / Part 1
Favirapir and COVID-19 / Part 2
Favirapir Global Studies
Coronavir (Ministry of Health)
Afiravir (Ministry of Health)
Avifavir Registration Certificate
Avifavir (Treatment)
Coronavir Registration Certificate
Coronavir Interim Results Summary
AREPLIVIR treatment for COVID-19. NEW generation cure for CORONA VIRUS, developed by Russian Company Promomed.
The quality of the product meets international standards. The benefit is a lower cost compared to analogues.
After four days taking cure Patients were completely cured. In 9 out of 10 cases, after treatment, the coronavirus was completely absent from the body.
The drug blocks the reproduction of the virus, stopping the spread of infection in the body.
Contact us for distribution information
The quality of the product meets international standards. The benefit is a lower cost compared to analogues.
After four days taking cure Patients were completely cured. In 9 out of 10 cases, after treatment, the coronavirus was completely absent from the body.
The drug blocks the reproduction of the virus, stopping the spread of infection in the body.
Contact us for distribution information
Approved by the Ministry of health of the Russian Federation
