Hello everyone. Greetings of the day. My name is Karthik Akinnapelli and I hope you're all doing well. Today I'll be presenting a phase 3 study findings which revolutionized UTI treatment. Here in this study, solopenum was compared to suprafloxacin for treating uncomplicated urinary tract infections. This study tackled the critical issue of raising antibiotic resistance and offered innovative strategies for managing complex infections. The results provide valuable evidence to guide treatment decisions in the evolving landscape of UTI resistance. Now, moving on to study design, this phase 3 trial was a double blind multicenter study conducted across 142 sites in 4 countries. It directly compared oral sulopenem to suprafloxacin, focusing on real world clinical outcomes in diverse healthcare settings. In terms of enrollment, the study included a total of 1671 women with symptomatic uncomplicated urinary tract infections. transcriptions, representing the primary demographic most affected by these infections. This study addresses a critical healthcare challenge, particularly in the US, where UUTIs account for approximately 30 million antibiotic prescriptions annually, making it one of the most common infections requiring antibiotic treatment. Now in ciprofloxacin non susceptible pathogens, sulopenum clearly demonstrated superiority. with 62. 6 percent success rate compared to ciprofloxacin's 26. 6%, with a highly significant p value. Now approximately 27 percent of urinary pathogens in the study were found to be resistant to ciprofloxacin, highlighting a significant challenge in current treatment options. This underscores the crucial role of sulopenum in bridging this gap by providing clinicians with an essential alternative, particularly for patients at a risk of treatment failure and disease progression. Now, not only did sulopenum address ciprofloxacin resistant infections. But it also demonstrated exceptional efficacy, achieving an 80 percent clinical and microbiological cure rate in patients with extensively drug resistant pathogens. Those that are resistant to either beta lactams, fluoroquinolones, or Bacrim, etc. This highlights solopenem's potential as a critical treatment option for patients with limited or no treatment alternatives. Its ability to overcome multiple resistance mechanisms presents a valuable oral treatment option. Potentially preventing hospitalizations and reducing reliance on last resort option which is intravenous antibiotics. This makes solopenem a crucial treatment option in managing resistant infections while improving patient outcomes and healthcare resource utilization. Now diving deep into antibiotic resistance. The analysis revealed that 32 percent of isolates were resistant to trimethoprim sulfamethoxazole, which is Pactrim, whereas 18 percent showed resistance to nitrofuranto, and this is across all pathogen species. This highlights a crucial evolution in bacterial defense mechanisms, representing a concerning shift in antimicrobial susceptibility patterns. These findings emphasize the urgent need for novel therapeutic strategies to combat emerging resistant trends and ensure effective treatment options remain available for managing uncomplicated UTIs. Now, beyond baseline resistance, the study also revealed that 41 percent of isolates that were initially susceptible to ciprofloxacin developed resistance post treatment, marking a significant shift in susceptibility patterns. This alarming rate of acquired resistance not only jeopardizes future treatment options for individual patients, but also amplifies the broader public healthcare crisis. of antibacterial resistance. These findings reinforce the urgent need for alternative treatment strategies and enhanced antimicrobial stewardship protocols to mitigate the accelerating threat of resistance. Now, in the overall study population, soloperium demonstrated statistical non inferiority to ciprofloxacin. overall study population includes both susceptible and non susceptible pathogens to ciprofloxacin with a clinical cure rate of 65. 6 percent for cilopenem compared to 67. 9 percent for ciprofloxacin. Additionally, a secondary analysis revealed that 18 percent of patients developed asymptomatic bacteria post treatment. with no significant difference between treatment groups. This finding suggests that routine follow up urine cultures in asymptomatic patients may not be clinically significant, potentially helping to reduce unnecessary antibiotic exposure and promote better antimicrobial stewardship. Now, sulopenum demonstrated a favorable safety and tolerability profile, with mild and transient diarrhea as the only notable adverse event, occurring in about 12. 4 percent of patients in sulopenum compared to 2. 5 percent in ciprofloxacin. Very importantly, no serious adverse events were attributed to the drug, and discontinuation rates remained below 3%. This exceptional safety profile positions solipenum as a strong first line treatment option for UDTIs, particularly in diverse, patient populations including elderly patients and those with comorbidities. Additionally, its minimum drug interaction profile and lack of QT prolongation further reinforces its suitability for widespread clinical use. Now, sulopenum offers significant therapeutic potential for the 63 percent of patients with beta lactamase non susceptible infections. A population that was previously had limited treatment options due to antimicrobial resistance. The results are particularly promising for the 13. 5 percent of patients with extended spectrum beta lactamase positive infections. As sulopenum provides a novel therapeutic approach that effectively overcomes traditional resistance mechanisms. This could play a crucial role in reducing dependence on last resort antibiotics, ultimately improving treatment outcomes and antimicrobial stewardship. Coming to future directions, further research is essential to explore personalized treatment approaches, gain deeper insights into resistance mechanisms. and refined clinical guidelines for UTI management. Additionally, conducting broader studies in diverse populations will be crucial to optimize treatment strategies in the face of rising antibiotic resistance, ensuring more effective and targeted therapeutic interventions. Now, finally, the key takeaways is that Celebenum has shown strong efficacy as an alternative to ciprofloxacin. particularly in drug resistant UTIs with over 90 percent, supports its role as a, sorry, with over a 90 percent success rates in ciprofloxacin non susceptible infections. It's excellent safety profile, with minimal adverse events and low discontinuation rates, supports its role as a first line treatment option. Moving forward, key priorities include integrating these findings into clinical guidelines, ongoing resistance surveillance, and developing targeted treatment protocols based on patient specific factors and pathogen susceptibility. These efforts are essential for enhancing antimicrobial stewardship and ensuring effective patient care amid rising antibiotic resistance. Thank you so much for giving me this opportunity.