Pegihep (peginterferon-α-2b biosimilar) / Zydus Lifesci - LARVOL DELTA

Efficacy and Safety of Pegylated Interferon-α2b in Moderate COVID-19: A phase 3, randomized, comparator-controlled, open-label study. (PubMed, Int J Infect Dis) - "PEG IFN-α2b induced early viral clearance, improved the clinical status and decreased the duration of supplemental oxygen. It provides a viable treatment option and can limit the spread of virus."

Clinical • Journal • P3 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNA1

Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19) (clinicaltrials.gov) - P2; N=40; Active, not recruiting; Sponsor: Cadila Healthcare Limited; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CRP • IFNG • IL6 • TNFA

Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19) (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Cadila Healthcare Limited; Trial completion date: May 2021 ➔ Aug 2021; Trial primary completion date: Apr 2021 ➔ Jul 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CRP • IFNG • IL6 • TNFA

Cadila gets approval to repurpose Hepatitis C drug for COVID-19 (Reuters) - "India’s Cadila Healthcare Ltd has received restricted emergency use approval from local regulators to use a Hepatitis C drug as a treatment for moderate COVID-19 in adults...The approval follows promising results from a late-stage study of the drug...Cadila said patients given its therapy in clinical trials had shown lesser need for supplemental oxygen, which is given to seriously ill COVID-19 patients to increase its supply in the blood and lungs. About 91% of patients treated with the drug, branded Virafin, tested negative for COVID-19 in standard RT-PCR tests by day seven, compared to nearly 79% who were given the standard of care, the company said earlier this month."

Non-US regulatory • Infectious Disease • Novel Coronavirus Disease

Zydus Cadila seeks regulatory approval for Covid-19 drug (Hindustan Times) - P3, N=250; "...91.15% of patients treated with Pegylated Interferon Alpha 2b, PegiHepTM were reverse transcription polymerase chain reaction (RT-PCR) negative by day seven, as compared to 78.90% on the standard of care arm in its phase 3 trials....'Interim results indicate that PegIFN, when administered early on, could help patients recover faster avoiding much of the complications seen in the advanced stages of the disease'....'With these positive results, the company has applied for an approval for additional indication with the DCGI for the use of PegIFN in the treatment of Covid-19,' said the company."

Non-US regulatory • P3 data: top line • Infectious Disease • Novel Coronavirus Disease

Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19) (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Cadila Healthcare Limited; Trial completion date: Jan 2021 ➔ May 2021; Trial primary completion date: Dec 2020 ➔ Apr 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CRP • IFNG • IL6 • TNFA

Zydus Cadila gets DGCI nod to start phase 3 trials of Covid-19 vaccine on patients (Livemint) - "...Zydus Cadila has said that it has received the approval from the Drugs Controller General of India (DCGI) to start the phase 3 clinical trials of the indigenously-developed Covid-19 vaccine on coronavirus patients....Zydus Cadila will conduct the phase 3 clinical trials with its biological therapy 'PegiHep'....Zydus Cadila, in a regulatory filing...has said that it has received approval from the DCGI to start the phase 3 clinical trials in COVID-19 patients with its biological therapy Pegylated Interferon alpha-2b or PegiHep. The trials, which will commence in December, will be conducted on 250 patients across 20-25 centres in the country, according to the company filing....The firm further said that it is conducting a similar phase 2 trial in Mexico and is also working with the US Food and Drug Administration (USFDA) to open an Investigational New Drug (IND) application for PegiHep in order to initiate appropriate clinical trials in America."

New P3 trial • Trial status • Novel Coronavirus Disease

Zydus Cadila completes phase 2 clinical trial in Covid-19 patients with Hepatitis C biological therapy PegiHep (Hindustan Times) - "Drug firm Zydus Cadila on Thursday said it has successfully completed a phase 2 clinical trial In Covid-19 patients with its biological therapy, ‘PegiHep’....'Based upon the results from its Phase 2 study, Zydus Cadila now plans to conduct a phase 3 clinical trial in India'. Zydus Cadila, which is a part of the Cadila Healthcare group, said Pegylated Interferon alpha – 2b significantly increased viral reduction and reduced the need for supplemental oxygen in moderate Covid-19 patients."

Trial completion • Infectious Disease • Novel Coronavirus Disease

Expert committee denies emergency approval for Zydus Cadila's HepC drug as COVID-19 treatment (CNBC-TV18) - "Drug regulator's subject expert committee has rejected Zydus Cadila's application for emergency use authorisation for its biological therapy, Pegylated Interferon alpha-2b or 'PegiHepTM' as a treatment of moderate COVID-19 patients. The rejection has come based on limited data and the small size of Phase 2 clinical trials....'After detailed deliberation, the committee recommended that available data is not adequate for grant of permission for emergency use of the drug in COVID 19 patients.'"

Non-US regulatory • Infectious Disease • Novel Coronavirus Disease

Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19) (clinicaltrials.gov) - P2; N=40; Recruiting; Sponsor: Cadila Healthcare Limited; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • CRP • IFNG • IL6 • TNFA

Pegylated Interferon - α2b With SARSCoV- 2 (COVID-19) (clinicaltrials.gov) - P2; N=40; Not yet recruiting; Sponsor: Cadila Healthcare Limited

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • CRP • IFNG • IL6 • TNFA

Zydus receives Mexican regulatory approval to conduct clinical trials with Pegylated Interferon alpha-2b (Business Standard) - "Zydus Cadila announced that it had received approval from the Mexican regulatory authority COFEPRIS to conduct clinical trials with its biological therapy, Pegylated Interferon alpha-2b, 'PegiHepTM'....Clinical and regulatory development of Pegylated Interferon alpha-2b in COVID-19 is being executed in Mexico by Avant SantResearch Center S.A. de C.V....Zydus had earlier approached the DCGI to investigate the role of Pegylated Interferon alpha-2b for COVID 19 and the clinical trials are now underway. The Company is also working with USFDA to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b."

New trial • Infectious Disease • Novel Coronavirus Disease