CFRX: Initiates Phase 1 Trial for Exebacase in Chronic Prosthetic Joint Infection…
NASDAQ:CFRX
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Business Update
Clinical Trial Initiated for Exebacase in Chronic Knee Prosthetic Joint Infections
On April 3, 2023, ContraFect Corp. (NASDAQ:CFRX) announced the initiation of a Phase 1b/2 clinical trial of exebacase in the setting of a minimally-invasive arthroscopic debridement, antibiotics, irrigation, and retention (DAIR) procedure in patients with chronic prosthetic joint infection (PJI) of the knee due to Staphylococcus aureus or Coagulase-Negative Staphylococci (CoNS).
The trial will be a randomized, double blind, placebo controlled two-part study of exebacase to assess its safety and efficacy. Part I of the study will evaluate the safety, pharmacokinetics (PK), clinical outcomes, and microbiologic response in patients through Day 42. The study allows for up to two doses of intra-articularly administered exebacase in addition to systemic antibiotics in up to two patient cohorts. Part II of the trial will be a long-term follow-up study of safety and efficacy parameters in patients who complete Part 1 of the trial. The follow-up assessments will be performed on Days 90, 180, 360, and 720.
In September 2022, ContraFect announced a presentation by Dr. Tristan Ferry at the 40th Annual Meeting of the European Bone and Joint Infection Society on data from a single center, exploratory, open label prospective study using a minimally invasive LysinDAIR procedure in patients with chronic knee PJIs.
The presentation included data from two cohorts, with each cohort consisting of four patients with chronic PJIs that received the LysinDAIR procedure (arthroscopic debridement with retention of the implant, followed by intra-articular administration of exebacase and systemic antibiotic therapy).
Cohort one consisted of patients experiencing their first episode of chronic knee PJI. Patients received three months of clindamycin and levofloxacin following the LysinDAIR procedure. Results showed that exebacase was well tolerated by all patients with no local or systemic serious adverse events related to exebacase treatment. Through a period of 36 months of follow up the patients have experienced no relapse of infection, no recurrence of joint effusion, and no loosening of the prostheses.
Cohort two included patients suffering from multi-drug resistant knee PJI. These patients received three months of systemic antibiotics plus additional suppressive antimicrobial therapy following the LysinDAIR procedure. Results for this cohort showed that exebacase was again well tolerated by all patients and no local or systemic events related to exebacase treatment were reported. Two patients experienced no relapse of infection through a follow up periods of up to 12 months. One patient experienced a relapse of infection of Staphylococcus caprae after six months. One patient died from an unrelated COVID-19 infection.
In October 2022, ContraFect presented a poster that included new clinical data for the LysinDAIR procedure in patients with chronic prosthetic hip infection (Ferry et al., 2022). Three patients were included in the study and all had previous iterative hip prosthesis exchange, a high total number of surgeries (6-10), and recent persistent or intermittent fistula. At two years follow up, all patients had resolution of fistula and no clinical signs of infection on suppressive antimicrobial therapy.
A recent editorial in the Journal of Bone and Joint Infections discussed the potential for lysins (exebacase and CF-296) as treatments for bone and joint infections (BJIs) due to their activity against coagulase-negative staphylococci, the bacteria most frequently involved in implant-associated BJIs, and their potential for both local and systemic anti-biofilm activity (Sendi et al., 2022). Current antibiotic treatments are often unable to resolve these infections, thus the authors postulated that the use of lysins could help to potentiate antibiotic activity and make these types of infections more easily treated.
Another recent publication highlighted the in vitro activity of exebacase against biofilms formed by Staphylococcus epidermidis isolated from PJIs (Souche et al., 2022). Results showed that exebacase displayed significant anti-biomass activity, significant bactericidal activity on biofilms, and worked synergistically with rifampicin, vancomycin, or daptomycin. The authors concluded that exebacase was a promising therapy that should be investigated further for its use in the treatment of PJIs alongside the aforementioned antibiotics.
Financial Update
On March 31, 2022, ContraFect announced financial results for the fourth quarter and full year 2022. As expected, the company did not report any revenues for the fourth quarter or full year 2022. Net loss for the fourth quarter of 2022 was $9.8 million, or $16.14 per share, compared to a net loss of $4.4 million, or $8.95 per share, for the fourth quarter of 2021. R&D expenses in the fourth quarter of 2022 were $4.4 million compared to $11.0 million in the fourth quarter of 2021. The decrease was primarily due to significantly reduced expenditures on CMC activities for exebacase, the continued closure of the Phase 3 DISRUPT trial, and decreased headcount and personnel costs following the restructuring of the company’s workforce in the third quarter of 2022. G&A expenses in the fourth quarter of 2022 were $2.3 million compared to $3.0 million in the fourth quarter of 2021. The decrease was primarily due to decreased headcount and related personnel costs after the restructuring of the company’s workforce in the third quarter of 2022.
For 2022, the company reported a net loss of $65.2 million, or $124.97 per share, compared to a net loss of $20.3 million, or $44.12 per share, for 2021. The net loss for the current year includes $4.8 million, or $9.23 per share, of non-cash charges related to the of the warrants issued in connection with the company’s December 2022 offering. Those charges were offset by a $4.2 million, or $8.03 per share, non-cash gain from the change in the fair value of the company’s warrant liabilities. In the prior year period, the net loss included an $26.9 million, or $58.46, non-cash gain from the change in the fair value of the company’s warrant liabilities. R&D expenses in 2022 were $44.7 million compared to $35.5 million for 2021. The increase was primarily due to the increase in spending on clinical activities related to the Phase 3 DISRUPT trial and on manufacturing costs for both exebacase and CF-370. G&A expenses in 2022 were $12.2 million compared to $11.8 million in 2021. The increase was primarily due to increases in legal expenses.
As of December 31, 2022, ContraFect had approximately $13.7 million in cash and cash equivalents. In March 2023, ContraFect completed a direct offering of common stock and warrants for net proceeds of $9.2 million. As of March 24, 2023, the company had approximately 1.6 million shares outstanding and, when factoring in stock options and warrants, a fully diluted share count of approximately 11.0 million.
Conclusion
We’re excited to see that the Phase 1b/2 trial of exebacase in PJI is underway. This is a great opportunity for the company to test the efficacy of exebacase in a new indication and one for which there are limited treatment options. We look forward to updates from the company regarding the trial throughout the year. In addition, we look forward to the IND filing for CF-370 so that a clinical trial can be initiated later this year. We have adjusted our model due to the two recent financings and the 1-for-80 reverse split and our valuation now stands at $7 per share.
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