Processa Enters Agreement to Develop HT-100 as Possible Fibrotic Disease Treatment

Processa Pharmaceuticals  announced it has entered into a global licensing agreement with Akashi Therapeutics to possibly develop and market HT-100, Akashi’s candidate to treat diseases associated with tissue fibrosis (scarring) and inflammation, including scleroderma.

HT-100 is an experimental, oral small molecule reported to have strong anti-inflammatory and anti-fibrotic properties. It has also been shown to stimulate the regeneration of muscle fibers.

The medication had been designated an orphan drug by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) as a potential treatment for Duchenne muscular dystrophy (DMD), a genetic disease in which muscle fibers gradually deteriorate and die.

A trial assessing HT-100 in improving muscle strength in children with DMD was placed on a clinical hold after one patient died during the study. The hold was lifted by the FDA in 2017, but the trial was subsequently terminated.

Based on the agreement, Processa is planning to start developing HT-100 as a potential treatment for adults with rare fibrotic diseases with limited therapeutic options. These include scleroderma, focal segmental glomerulosclerosis, and idiopathic pulmonary fibrosis.

“Processa needs to learn more about the safety and dose response of HT-100 while we determine the best way to clinically manage patients on this anti-fibrotic drug,” Sian Bigora, PhD, chief development officer at Processa, said in press release.

“In early 2020 we hope to begin to define, in collaboration with the FDA, an efficient way to develop HT-100 for all those patients who would benefit from this drug,” Bigora added.

Processa also plans to revisit potential pediatric indications for HT-100, including in DMD, at a later time.

“The Processa strategy is to add drugs to our portfolio which already have some clinical evidence of efficacy. This enables our team to efficiently develop these drugs for patients with a high unmet medical need condition, while the risk of failure associated with the clinical trials is decreased,” David Young, chief executive officer at Processa, said.

“This strategy… will now be implemented for HT-100. Since the quality of life for these patients is so often impaired given the lack of treatment options, the more efficiently we can develop these products, the sooner patients will experience the positive impact of these drugs on their lives,” Young concluded.