Pilot study of BioLexa Platform on diabetic skin ulcers achieves positive results


Hoth Therapeutics, a biopharmaceutical company focused on targeted therapeutics for patients suffering from indications such as dermatological and chronic wound disorders, has announced the initial results of its pilot study on the application of the BioLexa Platform on diabetic skin ulcers.

According to a statement, this trial was designed to establish foundational protocols for assessing the effectiveness of the BioLexa Platform—a therapeutic compound—for accelerating and improving wound healing in the context of acute and chronic diabetic ulcers, using an animal model of impaired wound healing developed at Massachusetts General Hospital (MGH), USA.

Specific objectives of the study included optimising the method of application of the therapeutic compound (BioLexa) on diabetic skin wounds in mouse models of acute and chronic diabetic wound healing established at MGH’s Vaccine and Immunotherapy Centre (VIC).

In addition to this, the trial aimed to optimise the staphylococcus aureus inoculation dose to achieve biofilm growth in the infected diabetic wound model.

An animal protocol amendment was submitted to and approved by the MGH Institutional Animal Care and Use Committee (IACUC) to allow the application of the BioLexa compound on wounds in the established mouse model.

A full biosafety protocol was also submitted to and approved by the Partners Institutional Biosafety Committee (IBC), allowing the use of pathogens such as s. aureus, and all work was performed in compliance with these institutionally approved protocols.

After 22 days post-injury, the animals were euthanized and the dressings on the wounds were removed to reveal the wounds and collect tissue biopsies.

Upon removal of the wound dressings and the obscuring cream, Dr. Ruxandra Sirbulescu, who designed and conducted the pilot study at MGH, observed that the majority of the wounds, treated with either BioLexa or the carrier base control of BioLexa, were fully closed and re-epithelialized.

While the present pilot study did not include wounds treated with saline solution, previous studies in this model have shown that wounds treated with control solutions, such as saline, remain fully open ulcers at 22 days post-injury.

Preliminary data suggests a benefit of BioLexa treatment over placebo in certain categories, although a larger, well-controlled study is required before any clear conclusion can be drawn on treatment efficacy.

Dr. Sirbulescu remarked: “We observed complete closure in all treated wounds, which is not typical for this experimental model. Moreover, several parameters associated with the quality of tissue regeneration were significantly improved after treatment of the open ulcers with BioLexa, including better collagen deposition and increased angiogenesis.

“Our next studies will aim to confirm the observed regenerative effects of the BioLexa platform in the context of chronic diabetic ulcers, with and without substantial bacterial burden.”

Robb Knie, CEO of Hoth Therapeutics, also commented: “Preliminary results indicated that, as a wound care product, Biolexa performed extremely well in a mouse model of diabetic ulcers. Hoth is excited about the next phase of our pilot program and look forward to sharing results upon the completion of the next module.”


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