CinnaGen Biosimilar Shows Promise in Treating COVID-19

A new study from Iran demonstrated that biosimilar interferon beta-1a (IFN-β-1a, ReciGen) is effective in helping to reduce symptoms and achieve virological clearance in patients suffering from the coronavirus disease 2019 (COVID-19).

“In the absence of specific treatment for COVID-19, there is an immediate need to find alternative treatments to manage this pandemic,” investigators wrote.

They found that biosimilar IFN-β-1a in combination with conventional therapy including hydroxychloroquine and lopinavir/ritonavir helped resolve COVID-19—related fever in all 20 patients included in the study after 8 days, whereas, other symptoms decreased gradually. However, symptoms such as cough, dyspnea, myalgia, and malaise persisted at the end of the study.

No deaths or significant adverse drug reactions were reported at the end of the 14-day study. ReciGen is produced by CinnaGen of Alborz, Iran.

More on the Study

The 20 patients included in the prospective noncontrolled study were on average 59 years of age and had COVID-19 infections confirmed by a throat swab test, an onset of symptoms for an average of fewer than 7 days, and severe disease.

All patients had their symptoms monitored daily for 14 days during hospital stays in March 2020. The mean amount of time each patient spent hospitalized was roughly 17 days.

At the time of hospital admission, all patients had COVID-19—confirmed samples, which were taken to assess the amount COVID-19 RNA in patients’ systems. After 10 days of treatment, 90% of patients had achieved virological clearance.

Additionally, the mean standard deviation (SD) of white blood cell count increased from roughly 5.10 at admission to 8.32 on day 7. The mean SD of lymphocyte count also increased from roughly 1126.86 at admission to 1303.44 by day 14.

Investigators analyzed lung computed tomography scans and chest x-rays that were taken on the day of admission and on day 14. The images showed diseased lung state and bilateral lung infiltration at admission and recovery from these conditions after 2 weeks.

Three patients (15%) received noninvasive mechanical ventilation for low oxygen saturation but were weaned from this after 5 to 19 days.

This was the first published study to evaluate the therapeutic efficacy of IFN molecules on COVID-19; however, previous studies have demonstrated efficacy in treating other coronaviruses, such as SARS-CoV and MERS-CoV.

Study Limitations

The study had several limitations, including use of a small sample, lack of a control group, and testing only ReciGen in conjunction with other medications. Investigators said they decided not to use a control group, because they had ethical concerns about depriving patients of effective treatments.

Additionally, investigators were unable to observe the effects of ReciGen alone because all patients received hydroxychloroquine and lopinavir/ritonavir in accordance with the national Iranian guideline on COVID-19 treatment.

“Considering the mentioned limitations, the results of this study should be interpreted cautiously, and further large trials are needed to show the therapeutic effects of IFN-β-1a in COVID-19,” wrote the investigators.

They also suggested that future trials should consider testing the therapeutic effects of other types of interferon molecules, including IFN-α.

For more about CinnaGen's biosimilar efforts, click here.

Reference

Dastan F, Nadji SA, Saffaei A, et al. Subcutaneous administration of interferon beta-1a for COVID-19: a non-controlled prospective trial. Int Immunopharmacol. Published online June 7, 2020. doi:10.1016/j.intimp.2020.106688