DS Biopharma, a privately held Dublin-based company with a proprietary bioactive lipid technology platform, has launched Afimmune, a spin-off focused on approaches to treating fibrosis and fibrotic conditions. These includenon-alcoholic steatohepatitis (NASH) and atopic dermatitis, as well as other inflammatory and pulmonary disorders such as chronic obstructive pulmonary disease (COPD), and idiopathic pulmonary fibrosis (IPF).
Afimmune will continue to develop DS102, an anti-fibrotic and anti-inflammatory compound, which the company plans to evaluate in patients with NASH and certain other pulmonary disorders. Recent preclinical data suggests that DS102 is significantly sequestered in lung tissue and has bronchodilatory, anti-inflammatory, and anti-fibrotic properties after oral administration.
Afimmune also has a number of other compounds in pre-clinical development.
“By spinning out DS102 into a new company, DS Biopharma can direct its full attention to developing products for inflammatory skin conditions, whereas Afimmune will focus on fibrotic conditions and pulmonary disorders,” Dr. John Climax, executive chairman of DS Biopharma, said in a press release.
DS Biopharma will be solely focused on the clinical development of DS107, an anti-inflammatory compound for atopic dermatitis and pruritus, and DS109 for other inflammatory skin disorders, such as acne.
Later this year, Afimmune expects to begin a Phase 2a clinical trial of DS102 in patients with NASH. The company is also planning to begin a Phase 2a study in patients with COPD following positive pre-clinical results.
A randomized and placebo-controlled, single-ascending and multiple-dose Phase 1 clinical trial assessed the safety, pharmacokinetics, and effect of oral DS102 administered over 28 days to 56 healthy volunteers. Results confirmed that DS102 was safe and well-tolerated, meeting the study’s primary safety objective.
Pulmonary fibrosis occurs when lung tissue becomes damaged and scarred. This thickened, stiff tissue makes it more difficult for the lungs to work properly, and as pulmonary fibrosis worsens, patients become progressively more short of breath. The lung damage caused by pulmonary fibrosis can’t be repaired, and for some, a lung transplant is the most appropriate option. New medications and therapies are needed to ease patients’ symptoms and improve their quality of life.