WOCKHARDT LIMITED

Wockhardt's Zaynich Demonstrates Superior Efficacy in Phase III cUTI Trial

5 months ago

• Wockhardt's Zaynich (zidebactam/cefepime) achieved superiority over meropenem in a Phase III trial for complicated urinary tract infections (cUTI). • The ENHANCE 1 study showed Zaynich had an 89.0% efficacy rate in combined clinical and microbiological cure, compared to 68.4% for meropenem. • Zaynich exhibited a 96.8% clinical cure rate and a safety profile comparable to meropenem in the multi-center trial across the US, Europe, and Asia. • Wockhardt plans to file a new drug application (NDA) with the USFDA and a marketing authorization application (MAA) with the EMA based on these results.

India's Nafithromycin Offers New Hope Against Drug-Resistant Pneumonia

6 months ago

• Nafithromycin, India's first indigenous antibiotic, targets drug-resistant community-acquired bacterial pneumonia (CABP) and offers a new treatment option. • Developed by BIRAC and Wockhardt, Nafithromycin boasts a three-day treatment regimen and is reportedly ten times more effective than azithromycin. • Clinical trials show a 96.7% cure rate with superior safety, minimal side effects, and broad-spectrum action against typical and atypical bacteria. • Awaiting final approval, Nafithromycin may be integrated into India's Ayushman Bharat scheme for increased accessibility and affordability.

Wockhardt's WCK 6777 Receives FDA Fast Track for Complicated UTIs and cIAIs After Phase I Success

8 months ago

• Wockhardt's WCK 6777 (Ertapenem/Zidebactam) received FDA Fast Track designation for complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). • A Phase I study of WCK 6777, conducted by the NIH, demonstrated a promising safety profile in 52 healthy volunteers with no serious adverse events. • WCK 6777 is a once-daily antibiotic designed for outpatient parenteral antimicrobial therapy (OPAT), targeting multi-drug resistant Gram-negative pathogens. • The drug aims to address the unmet need for outpatient management of MDR infections, potentially reducing hospital admissions and facilitating early discharge.