PGIMER Chandigarh Gets CDSCO Panel Nod to Study Bedaquiline

New Delhi: Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the academic trial of protocol titled, “A prospective, randomized study to evaluate the efficacy, safety, and pharmacokinetic-pharmacodynamics of Bedaquiline based regimen in multibacillary leprosy not responding to WHO-MDT”.

This came after the applicant presented the proposal for a grant of permission for the conduct of an academic trial which protocol titled, “A prospective, randomized study to evaluate the efficacy, safety and pharmacokinetic-pharmacodynamics of Bedaquiline based regimen in multibacillary leprosy not responding to WHO-MDT before the committee.”

Bedaquiline is a newly FDA-approved anti-TB drug, having a unique mechanism of action i.e. causes inhibition the proton pump activity of the ATP synthase in M. tuberculosis and targets the energy metabolism. It is found to be active within macrophages and is a promising agent in shortening the duration of anti-TB treatment. It has shown promising results in preclinical and clinical studies and it seems to be a good option for MDR and XDR-TB.

It acts by targeting subunit c of the ATP synthase of M. tuberculosis, leading to inhibition of the proton pump activity of the ATP synthase. Thus, the compound targets bacillary energy metabolism. ATP synthase is a critical enzyme in the synthesis of ATP for M. tuberculosis. The binding of bedaquiline to the oligomeric and proteolipic subunit c of mycobacterial ATP synthase leads to the inhibition of ATP synthesis. This leads to the death of mycobacteria.

At the recent SEC meeting for antimicrobial and antiviral held on 9th May 2024, the expert panel reviewed the proposal presented by PGIMER, Chandigarh for the grant to conduct the academic trial to evaluate the efficacy, safety, and pharmacokinetic-pharmacodynamics of Bedaquiline-based regimen in multibacillary leprosy not responding to WHO-MDT (WHO recommended multidrug therapy regimens).

After detailed deliberation, the committee recommended the conduct of an academic trial as per the protocol presented by the applicant.

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