3 firms get clinical trial approval for alternative Covid-19 drugs

Domestic players are working on multiple off-label therapies that may be useful for treating Covid-19. The drug regulator is evaluating several of these proposals that have come from firms such as Dr Reddy’s Laboratories (DRL), Piramal Pharma, and Cadila Healthcare, among others. 

Hyderabad-based DRL, for example, has been asked to conduct phase-3 clinical trial of a potential cancer drug (2-Deoxy-d-Glucose oral power, or 2-DG) to see if it works as a therapy for Covid-19 patients. 

The drug 2-DG stops glucose supply to the cells, which then start dying. It is a potential cancer drug as it works by preventing supply of glucose to cancerous cells. The drug 2-DG is not yet an approved drug, but there have been multiple studies across the globe for treatment of cancers. The idea is that along with other anti-virals, 2-DG can help prevent replication of the Sars-CoV-2 virus in inflammed lung cells of Covid-19 patients. 

The subject expert committee (SEC), which is advising the Central Drugs and Standards Organisation (CDSCO) on matters related to Covid-19 and evaluating proposals under the accelerated approval process during the pandemic, has asked DRL to submit a protocol for phase-3 clinical trial of this drug with an ‘adequate’ sample size. 

The SEC has noted after its meeting, held on October 13, that the phase-2 study results have shown efficacy with optimum dose of 90mg/kg. "However, the sample size was small in the phase-2 study for grant of market authorisation," it said. 

The SEC advices the Drug Controller General of India on applications that seek approval for clinical trials for drugs and vaccines. DRL has conducted the phase-2 trial of the drug 2-DG with the Institute of Nuclear Medicine & Allied Sciences, a Defence Research and Development Organisation arm. 

Mumbai-based Piramal Pharma, on the other hand, is working on herbal drug Sphaeranthus Indicus’ extract. This is a medicinal plant widely used in India’s traditional system of medicine for treating ailments like epilepsy, mental illness, jaundice, diabetes, leprosy, cough, hernia, and hemorrhoids, among other diseases. 

According to a review of the plant done by V J Galani, B G Patel, and D G Rana, methanol extracts of the plant showed inhibitory activity against a type of coronavirus that infects mice and the herpes simplex virus. The extract also exhibited antiviral properties. 

Piramal said the company did not wish to comment on the clinical trial plans as they were in their silent period before quarterly results. The firm had presented their proposal for protocol amendment before the SEC, and the committee approved the protocol after detailed deliberation. 

Ahmedabd-based Cadila Healthcare, which is also in the race to develop a vaccine against the novel coronavirus, got the SEC’s approval for their clinical trial protocol for tumour drug adalimumab for patients with Covid-19. 

Established anti-tumour necrosis factor therpaies like adalimumab have shown that they can decrease inflammation and works in diseases like rheumatoid arthritis and inflammatory bowel disease, and thus, they can also have potential treating effect on patients with Covid-19 who develop acute respiratory distress syndrome due to inflammation of the lung tissue. Cadila plans to conduct trials with pre-filled syringes of adalimumab on Covid-19 patients.