An H.C. Wainwright & Co. report discussed the implications of data indicating "overwhelming evidence of efficacy" for this company's nonantibiotic anti-infective for treatment of catheter-related bloodstream infections.
In a July 26 research note, analyst Ram Selvaraju reported that H.C. Wainwright & Co. raised its price target on Buy-rated CorMedix Inc. (CRMD:NYSE.MKT) to $3 per share from $2 following "best case scenario" news from the Data and Safety Monitoring Board (DSMB) regarding the LOCK-IT-100 Phase 3 trial. CorMedix's current share price is around $0.55.
The DSMB recommended the study be stopped "due to overwhelming evidence of efficacy seen in the predefined interim analysis," Selvaraju relayed.
In LOCK-IT-100, CorMedix's lead candidate Neutrolin, a nonantibiotic anti-infective, was being evaluated against a Heparin catheter lock-flush solution as treatment of catheter-related bloodstream infections. The interim analysis was performed after 28 such infections occurred among the study patients who had central venous catheters and were on hemodialysis. The primary endpoint was fewer catheter-related bloodstream infections.
The DSMB's conclusion is "particularly impressive given such a small number of events and leads us to believe that perhaps only one or two infections—or even none at all—occurred in the Neutrolin arm."
Selvaraju noted that interim analysis results will likely be sent to the FDA within the next few weeks. "We feel that the FDA could prove amenable to considering fast-tracked submission of Neutrolin for review and accelerated approval for the product in the U.S.," he added. This is due to the significant unmet need with respect to treatment for patients who develop catheter-related bloodstream infections and the potential severity of these infections, which lead to death in 20% or more of patients.
The analyst also indicated that with the LOCK-IT-100 pivotal trial being cut short, filing with the FDA could take place by the end of 2018, and FDA approval could happen by 2019. This is sooner than the initial target for a commercial release in the U.S., which was no earlier than 2020. The DSMB's determination of clear efficacy could accelerate commercial sales outside of the U.S. as well.
Further, were Neutrolin to be approved, CorMedix could choose to launch the product itself, could pursue a licensing or partnering arrangement with a more established firm to sell the product, or could seek an acquisition deal. "We believe that the strength of the LOCK-IT-100 data—even from an interim analysis readout—is such that Neutrolin should now be regarded as a valuable potential asset for any company seeking to develop or maintain a presence in the U.S. hospital-based products market," Selvaraju purported.
As for CorMedix's finances, Selvaraju wrote, "We consider the existing resources sufficient to fund operations near term."