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CFRX: New Clinical and Microbiological Data Presented on CF-301; New Financing To Fund Company Past Phase 2 Results for CF-301

07/27/2017
David Bautz, PhD

NASDAQ:CFRX

Business Update

New Clinical and Microbiological Data Presented on CF-301

ContraFect Corp (NASDAQ:CFRX) recently presented five posters at the American Society for Microbiology (ASM) Microbe 2017 conference. Initial data from the Phase 1 study of CF-301, which was released in late 2015, showed the compound to be well tolerated with no adverse safety signals. The new data further supports the safety profile of CF-301, including an absence of acute cardiovascular and inflammatory responses. In addition, the company presented data showing CF-301 has a low propensity to induce resistance and that very low concentrations of CF-301 may increase susceptibility to conventional antibiotics. 

Poster #1: Inflammatory Markers in a Phase 1 Placebo Controlled Dose Escalating Study of Intravenous Doses of CF-301 in Human Subjects

Since CF-301 is a nonhuman protein, it is conceivable that dosing could elicit an inflammatory response, thus a range of inflammatory markers were evaluated before and after dosing. ContraFect analyzed high-sensitivity C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR), and complement factors Bb, C3a, C5a, and CH50. IL-6 and TNF-α were only to be collected if a subject experienced infusion reaction symptoms, and since that did not occur those factors were not analyzed. 

The data showed that outside of one subject who received CF-301 having an increase in hsCRP on Day 8 following infusion (with no associated clinical symptoms), there was little to no change in hsCRP for those who received CF-301, with similar changes seen in the placebo group.

There were also no differences between placebo and CF-301 treated subjects for any of the other factors evaluated. The results suggest that there is a low propensity for a single dose of CF-301 to induce an inflammatory response. 

Poster #2: Low Propensity of Resistance Development In Vitro in Staphylococcus aureus with Lysin CF-301

ContraFect had previously performed a serial passage study using the methicillin-resistant Staphylococcus aureus (MRSA) strain MW2. Those results showed a 2-fold increase in the minimum inhibitory concentration (MIC), however this never increased beyond 2-fold. 

As a follow up, additional serial passage studies were performed using both MW2 and the methicillin-sensitive S. aureus (MSSA) strain ATCC 29213 in different types of media along with human serum. The following graphs show that the CF-301 MIC never increased more than 2-fold in any type of media or human serum, while comparator agents demonstrated high-level resistance (up to 128-fold; graph E)

Even with a 2-fold increase in MIC, those variants will remain susceptible to the clinical dose of 0.25 mg/kg based on exposure attainment studies and pharmacokinetic modeling. Importantly, these results suggest that the propensity for CF-301 resistance in S. aureus is low.

Poster #3: The Sub-MIC Effect of CF-301 on Staphylococcus aureus 


ContraFect had previously performed a serial passage study using the methicillin-resistant Staphylococcus aureus (MRSA) strain MW2. Those results showed a 2-fold increase in the minimum inhibitory concentration (MIC), however this never increased beyond 2-fold. 

As a follow up, additional serial passage studies were performed using both MW2 and the methicillin-sensitive S. aureus (MSSA) strain ATCC 29213 in different types of media along with human serum. The following graphs show that the CF-301 MIC never increased more than 2-fold in any type of media or human serum, while comparator agents demonstrated high-level resistance (up to 128-fold; graph E)

Phase 2 Trial of CF-301 in Bacteremia Underway

On May 25, 2017, ContraFect Corp. (CFRX) announced the initiation of a Phase 2 clinical trial to evaluate CF-301 as a potential treatment of bacteremia caused by both methicillin-resistant (MRSA) and methicillin-sensitive (MSSA) strains of Staphylococcus aureus.  

The study is an international, multicenter, randomized, double blind, placebo controlled trial with a superiority comparison between CF-301 combined with the standard of care antibiotics compared to placebo with the standard of care antibiotics. The trial will include 115 patients randomized 3:2 to receive a single dose of 0.25 mg/kg CF-301 administered via a two-hour infusion or placebo. The primary endpoint of the study will be early clinical response. Safety, tolerability, and pharmacokinetics will also be examined along with additional exploratory clinical and health economic endpoints. We anticipate that the Phase 2 trial will cost anywhere from $10 to $20 million to run and topline results should be available in the fourth quarter of 2018. The company is not planning to perform an interim analysis.

Financial Update

On July 20, 2017, ContraFect announced the pricing of a public offering of 32 million shares of common stock and related warrants to purchase 16 million shares of common stock with an exercise price of $1.55 per share. The purchase price for one share of common stock and related warrant was $1.25. The net proceeds from the offering will be approximately $36.9 million. Importantly, this money will provide sufficient capital to fund operations past the expected release of data from the Phase 2 trial of CF-301 in the fourth quarter of 2018. 

Conclusion and Valuation

The data recently presented by ContraFect helps to further establish the safety of CF-301 and its ability to increase susceptibility of S. aureus strains (including MRSA strains) to antibiotics. The company has initiated the Phase 2 study of CF-301 and we look forward to evaluating the results next year, which we anticipate in 4Q18. We have constructed a probability adjusted discounted cash flow model that takes into account potential future revenues from CF-301 and the company’s influenza treatment CF-404. Our valuation currently stands at $7 per share, and we believe that all investors interested in the anti-infective space should consider taking a close look at ContraFect.

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