Chromis published results of a multi-center open label post-marketing clinical study in 940 COVID-19 patients confirming efficacy of Avifavir at CROI2021

Chromis (Russia), a joint venture of the ChemRar Group and the Russian Direct Investment Fund (RDIF), and its partner Viriom Inc., a San Diego CA-based biotech reported a summary of the multicenter, open-labeled, efficacy and safety study of Avifavir (favipiravir) in patients with COVID-19 at the Conference on Retroviruses and Opportunistic Infections CROI2021.

Background:

Favipiravir as well as remdesivir are currently the leading directly acting antiviral drugs against COVID-19 globally. Avifavir received emergency use authorization from Russia’s Ministry of Health in May 2020 based on an interim report of an open label comparative Phase 2-3 clinical study in hospitalized medium severe and severely ill patients and became the world’s first favipiravir-based drug approved for the treatment of COVID-19. It obtained full market authorization in November 2020 and was included in the Russian standard of care as a first line treatment for ambulatory and hospitalized COVID-19 patients.

The efficacy and safety of Avifavir was statistically significantly demonstrated in two Phase 2 and Phase 3 clinical trials in 460 medium severe and severely ill COVID-19 patients conducted between April and October 2020. Multiple regional bridging studies have since been completed and others are ongoing in Latin America and Central and South East Asia and the Middle East.

In the last year, Avifavir has been delivered to over 1,000,000 patients in 17 countries.. Avifavir is being submitted for rolling review in EMA and a submission is planned with the US FDA.

Study Design and Demographics:

A multi-center, open label post registration study of efficacy of Avifavir was conducted  in medium severe   and severe ill hospitalized COVID-19 patients included 940 patients: 470 each on Avifavir  or Standard of Supportive Care (SOC). SOC included antiviral, antibiotics and medications for symptoms relief, i.e., antipyretics, anti-tussives, etc. The study targeted time to viral clearance and clinical improvement as primary outcomes and indicators of the drug’s effectiveness.

Patients data were obtained from the Unified national (Russian) healthcare information system.  The Avifavir cohort included 52.3%/47.7% females/males 18 years of age and older vs 56.4%/43.6% ratio of the same age group patients for SOC cohort.   The majority of patients (59.6% in Avifavir cohort and 60.4% in SOC) were moderately ill while 19.6% of patients in Avifavir cohort and 20.2% in SOC cohort were severely or extremely severely ill COVID-19 patients. Median duration from onset of symptoms was 4.9 days for Avifavir and 4.7 days for SOC patients.

Avifavir was dosed for 10 (median 9.2) days, using body weight as a cut-off: for patients with BW<75 kg: a dose of 1600 mg BID on Day 1, then 600 mg BID on Days 2 to 10 and for patients with BW> 75 kg: a dose of 1800 mg BID on Day 1, then 800 mg BID on Days 2 to 10.

Study Results and Conclusions:

The median time to virus elimination in the Avifavir and SOC groups was 8 and 12 days, respectively (p<0.001). The median time to clinical improvement in the Avifavir and SOC groups was 12 and 15 days, respectively (p <0.001) with statistically significantly greater number of patients with clinical improvement in Avifavir  vs. SOC group, at 7 days (p=0.0248) and 14 days (p<0.001) of treatment initiation.

Patients in the Avifavir arm demonstrated a reduced mortality rate 5.7% vs 8.3% in SOC cohort. Avifavir was well tolerated in this study with no new or unexpected AEs.

In conclusion, Avifavir has shown early and statistically significant differentiation compared to Standard of Supportive Care, with a 33% faster virological response, 20% shorter time to normalized clinical symptoms; and 31% lower mortality rate. Study results support the importance of an early initiation of direct antiviral therapies, such as Avifavir for the treatment of COVID-19 patients.

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ChemRar Group ChemRar is a unique group of biotech start up, R&D and pharmaceutical companies developing and commercializing innovative medicines for treatment of cardiometabolic and infectious diseases, oncology, and CNS pathologies in Russia and other countries. https://en.chemrar.ru

Russian Direct Investment Fund (RDIF) is Russia’s sovereign wealth fund established in 2011 to make equity co-investments, primarily in Russia, alongside reputable international financial and strategic investors. RDIF acts as a catalyst for direct investment in the Russian economy. RDIF’s management company is based in Moscow. Currently, RDIF has experience of the successful joint implementation of more than 80 projects with foreign partners totaling more than RUB1.9 tn and covering 95% of the regions of the Russian Federation. RDIF portfolio companies employ more than 800,000 people and generate revenues which equate to more than 6% of Russia’s GDP. RDIF has established joint strategic partnerships with leading international co-investors from more than 18 countries that total more than $40 bn. Further information can be found at www.rdif.ru

Viriom Inc. is advancing breakthrough medicines that are effective and affordable with the ultimate goal of curing HIV, chronic HBV and respiratory infections in both developing and developed countries. Viriom’s pipeline includes: Elpida® (elsulfavirine), the best-in-class NNRTI that obtained first market authorization in 2017; extended release weekly oral formulations; and long-acting injectable therapy and prophylaxis. Viriom combines its extended release and long-acting injectable compounds with partners’ therapies with curative potential. Viriom supports Chromis, RDIF and ChemRar with R&D and regulatory efforts in established pharmaceutical markets. www.viriom.com