The US Patent and Trademark Office (USPTO) has recently approved the third patent application submitted by the biotech company Tissue Repair (ASX: TRP), which focuses on developing wound-healing agents. This patent—titled “BIOLOGICAL POLYSACCHARIDE COMPOUND” ]—includes claims that extend to the Glucoprime® compound and its molecule, allowing for various applications. 

Glucoprime and its derivatives serve as the foundational technology for Tissue Repair’s primary drug candidate, TR987, designed for treating Venous Leg Ulcers (VLUs) and its cosmetic product TR Pro+TM. 

VLUs are chronic wounds on the lower legs, usually caused by impaired blood circulation in the veins, often due to venous insufficiency. This leads to elevated pressure in the veins, causing damage to surrounding tissues.

The technology exhibits wide-ranging applications in animal and human settings, addressing wounds topically and/or internally.

Tissue Repair’s co-founder Tony Charara said, “The patent protection across the three allowed patents now in force is robust. We have delivered on our prospectus objectives of securing solid IP protection at a critical point as we explore the next stage of commercialisation for TR Pro+TM and the planned Phase 3 Clinical Trial commencement for our lead drug candidate TR987®.”

In the September 2023 quarter, the advanced biotech company reported operating outflows of over $1 million, primarily attributed to expenses associated with the development of TR987® and the commercialisation of TR Pro+TM offset by interest income. Tissue Repair has spent about $5 million on the chronic wound repair drug and $360k on the upcoming Phase 3 trials.

The newly granted patent protects a range of additional applications to advance Tissue Repair’s fundamental technology platform commercially. Crucially, it offers enhanced protection for commercialising its TR Pro+TM cosmeceutical product. TR Pro+TM, a cutting-edge post-procedure topical, was recently introduced in a pilot program in NSW and has demonstrated strong monthly sales in approximately 90 clinics.

The Company has received consistently positive and substantial feedback from both patients and clinicians during the pilot program, confirming its superior effectiveness compared to existing products. It actively explores discussions with potential partners for additional overseas distribution agreements in specific regions.

The recent approval of the third patent builds upon the prior approval of Tissue Repair’s second patent. This patent includes claims for utilising the Company’s Active Pharmaceutical Ingredient (API), Glucoprime®, in topically applied methods for treating various skin conditions. 

The Company had secured its first patent approval in April 2022, outlining the method of manufacturing Glucoprime®. At present, there are no known alternative processes for producing this exclusive biological polysaccharide molecule.

Currently, Tissue Repair is the only advanced biotechnology company worldwide aiming to initiate a Phase 3 drug program for VLUs in 2024. Successful trials for its primary drug candidate, TR987, would mark the first approval of a drug for VLUs in more than 25 years.