Norwegian firm SoftOx Options AS says it has acquired the ultimate report and evaluation of its part 1 research evaluating the security and tolerability of SoftOx Biofilm Eradicator (SBE-01).

SBE-01 is SoftOx’s antimicrobial answer for the remedy of power wounds. 

The research is a first-in-human investigation of the security, tolerability, and antimicrobial efficacy of single and a number of doses of SBE in sufferers with power leg wounds. The part 1 research was divided into two elements: a randomized, blinded, single ascending dose (SAD) part, adopted by an open label, a number of ascending dose (MAD) part, the place sufferers have been handled once-daily or twice-daily over 5 days.

Key findings 

The ultimate report reaffirms earlier findings that SBE is secure and well-tolerated by sufferers affected by power leg wounds. There have been no statistically vital variations within the analysis of ache throughout and after the wound cleansing process evaluating SBE with placebo. The research discovered that formulations of SBE constantly lowered the bacterial burden within the wound in contrast with pre-treatment. There was additionally proof of wound therapeutic with a discount in wound space of between 24 to 36% after simply 5 days’ remedy. 

Thomas Bjarnsholt, chief scientific officer at SoftOx, stated: “In line with the World Well being Group, antimicrobial resistance is without doubt one of the largest threats to human well being, which is why it’s crucial to develop new and revolutionary methods to deal with bacterial infections. 

“These outcomes clearly counsel that the SBE answer is secure and well-tolerated by sufferers and might considerably cut back the general bacterial burden in wounds, finally selling wound therapeutic. Taken along with earlier scientific research, these information are early proof-of-concept for the expertise as a possible remedy candidate for sufferers affected by power wounds worldwide.”

Subsequent steps

Having demonstrated early proof-of-concept for the SBE challenge and in accordance with the corporate’s company technique, SoftOx will search a strategic accomplice to additional develop and advance its wound care phase inside acute and power indications.

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