Sun Pharma Asked to Resubmit Revised Phase III Protocol for Delafloxacin CABP Trial
New Delhi: In a significant regulatory decision, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) directed Sun Pharma Laboratories Limited to submit a revised Phase-III clinical trial protocol for its antibacterial agents Delafloxacin Tablets 450 mg and Delafloxacin for Injection 300 mg/vial.
The committee concluded that the trial can proceed only after Sun Pharma incorporates mandatory protocol modifications and resubmits the updated Phase-III study design.
During the meeting, the committee evaluated File Nos. ND/MA/25/000118 and ND/MA/25/000117, along with the study protocol ICR/25/010 (Version 1.0 dated 14 July 2025) submitted for the proposed Phase-III clinical trial in Community Acquired Bacterial Pneumonia (CABP). The firm had proposed a prospective, multicenter, randomized, open-label, active-controlled Phase-III study comparing Delafloxacin (in both injection and tablet forms) with Levofloxacin injection and tablets in adult CABP patients. The trial aimed to evaluate the efficacy and safety of Delafloxacin as an emerging antibacterial option for community-acquired respiratory infections, especially where rising resistance patterns restrict treatment choices.
The SEC highlighted that the study population must reflect a clinically relevant subset—patients with severe CABP who possess risk factors for Multi-Drug Resistant (MDR) organisms. Given that Delafloxacin is a broad-spectrum fluoroquinolone, the committee further noted that the protocol should incorporate stringent safety oversight due to class-effect risks, including cardiac and neurological adverse effects commonly associated with fluoroquinolone antibiotics.
Accordingly, the committee mandated two critical modifications that must be included in the revised protocol:
Enrollment should be limited to patients with severe CABP who have MDR risk factors, ensuring a high-risk population suitable for evaluating Delafloxacin’s clinical benefit.
The protocol must incorporate monitoring for QT interval prolongation and neuropathy, both identified as key safety parameters linked to fluoroquinolone therapy.
Delafloxacin, recognised globally for its dual activity against gram-positive pathogens including MRSA and gram-negative respiratory bacteria, is positioned as an advanced fluoroquinolone candidate for difficult-to-treat pneumonia cases. Sun Pharma plans to introduce both oral and injectable formulations in India following completion of the required clinical development pathway.
The SEC concluded that Sun Pharma must submit the revised Phase-III protocol to CDSCO for thorough scientific review before any trial initiation can be permitted.
