CFRX: IND Application for CF-370 Submitted to FDA…
NASDAQ:CFRX
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Business Update
IND Application for CF-370 Submitted to FDA
On September 18, 2023, ContraFect Corp. (NASDAQ:CFRX) announced that it had submitted an Investigational New Drug (IND) application to the U.S. FDA on September 15, 2023 for CF-370 for the treatment of hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). The FDA has 30 days to respond if additional information is required, however if the agency does not have comments or concerns then after 30 days ContraFect is eligible to begin a clinical trial. A first-in-human trial could begin as early as the fourth quarter of 2023, assuming the FDA doesn’t require any additional information for the IND.
The following slide gives an overview of the planned early stage clinical trials for CF-370. The Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of CF-370 in healthy adult subjects through both a single ascending dose (SAD) and multiple ascending dose (MAD) trial. There will also be an evaluation of the lung concentration of CF-370 through bronchoalveolar lavage.
HABP/VABP are serious and potentially life-threatening infections that have a high mortality rate. They are currently the most common type of hospital-acquired infections in acute care hospitals and are a significant issue for patients in the intensive care unit (CDC). A recent study of 17,819 patients across 253 acute care hospitals showed that the mortality rates for ventilated hospital-acquired pneumonia, ventilator-associated pneumonia, and non-ventilated hospital-acquired pneumonia were 29%, 21%, and 12%, respectively (Zilberberg et al., 2022). The most commonly implicated Gram-negative pathogens in HABP/VABP are Pseudomonas aeruginosa, Acinetobacter species, Klebsiella species, Escherichia coli, and Enterobacter cloacae. Many of these species are multi-drug resistant (MDR) or extensively-drug resistant (XDR), making the infections all the more difficult to treat while resulting in a heavy economic burden. The estimated median total hospital cost for ventilator-associated pneumonia patients is $77,657.
Conclusion
The IND submission for CF-370 is a great milestone for ContraFect as the company continues to execute on its business plan. We look forward to additional updates regarding the upcoming Phase 1 study of CF-370, which we currently estimate could begin in the fourth quarter of 2023, assuming the FDA does not request any additional information for the IND submission. With no changes to our model our valuation remains at $7.00 per share.
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