EnZen Invests in Thirona to Help Develop Topical Fibrosis Therapy

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by Marta Figueiredo PhD |

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Thirona Bio has partnered with EnZen Therapeutics to accelerate the development of its experimental topical therapy FBM5712 for scleroderma and other conditions associated with scarring (fibrosis).

EnZen’s investment in Thirona, part of a convertible promissory note arrangement, may be converted into equity in the long run.

The companies will also discuss a potential agreement whereby EnZen’s parent company, Encube Ethicals, would manufacture FBM5712 in a current good manufacturing practice (cGMP) facility on behalf of Thirona to support future clinical trials.

The cGMP certification indicates compliance with the U.S. Food and Drug Administration’s regulations regarding the methods, facilities, and controls used in manufacturing, processing, and packing of a treatment.

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“EnZen’s investment will support and accelerate Thirona’s development of FBM5712,” Gordon Foulkes, PhD, Thirona’s co-founder and CEO, said in a press release.

“Our team has enjoyed a close collaboration with scientists in the Encube Ethicals group, and we look forward to deepening the relationship through the current transaction,” he added.

Scleroderma, also known as systemic sclerosis, is characterized by blood vessel abnormalities, inflammation, and tissue fibrosis. As the disease progresses, the skin becomes progressively thicker and internal organs may become increasingly scarred, affecting their function.

FBM5712 is a small molecule that works by blocking the activity of activin receptor-like kinase 5 (ALK5), the receptor protein of a key player in fibrotic diseases called transforming growth factor beta (TGF-beta).

Previous studies showed that suppressing ALK5 can reduce tissue fibrosis in organs, including the lungs, kidneys, and liver.

As such, FBM5712, given as a topical treatment, is expected to block TGF-beta signaling locally, thereby lessening fibrosis while minimizing the potential safety issues associated with systemic TGF-beta suppression.

In addition to scleroderma, Thirona is developing the experimental therapy for other fibrotic conditions, such as keloid scars and certain cancers where there are currently no effective therapies.

“We believe that FBM5712 is a promising preclinical asset,” said Dominic King-Smith, PhD, EnZen’s CEO.

“Inhibition of [TGF-beta] is a well validated target and Thirona’s focus on local treatments for scleroderma, keloids and cancer is closely aligned with EnZen’s focus on development of topical therapies for less common dermatology conditions,” he said.

Added Mehul Shah, founder and managing director of Encube, and chairman of EnZen’s board of directors: “This collaboration with Thirona broadens our horizon and creates new opportunities to touch the lives of patients.”

“We look forward to executing EnZen’s strategy and driving innovation to improve the quality of life for those burdened with diseases,” Shah said.

In June, Thirona also joined forces with MannKind Corporation to develop and test a new, dry-powder formulation of FBM5712 so that it can be delivered directly to the lungs to treat fibrotic disorders.