New Delhi: As biologic drug Itolizumab failed to impress the national Covid-19 task force for inclusion in clinical management protocols for treating coronavirus patients, its Bangalore-based manufacturer, Biocon, is now preparing to present ‘more data’ for consideration.
Itolizumab is a ‘humanised monoclonal antibody’, developed by Biocon in collaboration with the Centre for Molecular Immunology (CIM) in Cuba.
While Itolizumab is an already approved drug used for treating skin ailment psoriasis, it was approved for “restricted emergency use” in the treatment of coronavirus by the Drugs Controller General of India (DCGI) on 12 July.
However, the taskforce has decided against its inclusion in clinical management protocols — guidelines that set the standard treatment regimen for Covid-19 — despite the DCGI approval.
“The issue of including the drug in the clinical protocols was discussed in a meeting held on Friday. A majority of the members of the task force opined that there was not enough evidence currently to get the drug included in the clinical management protocols for Covid-19,” an official source told news agency PTI.
To check the efficacy of the drug on Covid, the company has so far done a phase 2 study on 30 Covid-19 patients.
Based on the media reports about the rejection of the drug, the company has now decided to share more data as “evidence”, which it has derived from off-label use of the drug on 1,000 patients. Off-label means doctors have prescribed the drug after taking the consent of the patient on compassionate grounds.
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“The national Covid-19 task force needs to see more evidence and we will provide them a large sample of real world data to enable the committee to reconsider its decision on inclusion of Itolizumab in the clinical management protocol,” a company spokesperson told ThePrint.
“The drug has been used on nearly 1,000 patients across the country and generated good outcome data.”
The company also claimed that “Cuba has authorised the use of Itolizumab in cases of Covid-19 after concluding the introduction of the drug had a significant impact in reducing the mortality of these patients post a rigorous evaluation of data submitted by Biocon’s Cuban partner, Centre of Molecular Immunology, and various institutions of the Cuban health system.”
“This authorisation was also based on the results from the controlled trial carried out by Biocon in India, which confirmed the data obtained in Cuba on Itolizumab’s potential to reduce mortality.”
Phase 4 trials to check adverse events planned
The company said it has “also announced plans for a 200-patient, pan-India Phase 4 trial to be conducted across 10-15 hospitals”.
“The study protocol has been submitted to the DCGI and we will commence the trial soon. The results from the Phase 4 will create a larger body of evidence for efficacy of Itolizumab in Covid-19 complications,” added the spokesperson.
The DCGI had approved the drug without the mandatory Phase III clinical trials, a move which raised eyebrows among public health experts. Phase III is deemed important as it is a large study involving several patients, which helps in estimating the therapeutic efficacy of an experimental drug better along with observing its risks and adverse reactions before the drug enters the market.
Phase 4, which Biocon has now applied for, is done as “post marketing surveillance” and is also known as “confirmatory trial”. Under this phase, the data on serious adverse reactions (SAEs) of the drug are noted and reported to the regulator.
‘No Phase 3 trial as drug’s safety profile already established’
According to the company’s spokesperson, the drug has been in the market since the last seven years where its safety profile has already been established.
“Itolizumab, a repurposed drug, received DCGI approval in 2013 after a comprehensive clinical study, including a large Phase 3 trial for psoriasis, which is an autoimmune condition,” the spokesperson said.
The safety of the drug has already been established seven years ago, the company emphasised adding that “Itolizumab has a seven-year proven track record of safety as doctors in India have been prescribing this biologic therapy to treat acute psoriasis”.
Itolizumab, according to the findings by the company, works through its immuno-modulating mechanism of action on Covid-19 patients when they experience a Cytokine Release Syndrome (CRS) or are at the verge of getting into the CRS stage.
As the body enters the stage, its own immune cells start to attack healthy tissues, which may lead to organ failure and death.
Moreover, it added, “Based on the encouraging study results of the pivotal Phase 2 conducted by Biocon in India, our US-based partner, Equilllium, is planning to conduct a global randomised controlled clinical trial of Itolizumab in Covid-19 patients for which it will file a US investigational new drug application (IND) soon.”
Disclaimer: Biocon’s chairperson and managing director Kiran Mazumdar-Shaw is among the distinguished founder-investors of ThePrint. Please click here for details on investors.
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