Stockholm, Sweden, 12 July 2022 –
Gesynta Pharma AB today announces that all patients have
been recruited for the company’s clinical Phase II study with the drug candidate GS-248, which is
being evaluated as a treatment for the rare disorder systemic sclerosis. The study is intended to
demonstrate proof-of-concept and to evaluate the safety profile of GS-248. Top-line data is
expected in the fall of 2022.
Systemic sclerosis (also known as scleroderma) is a chronic, autoimmune disease that leads to
serious damage to the microvessels. Already in the first stages of the disease, patients are affected
by episodes of reduced blood flow in fingers and toes. The episodes, known as Raynaud’s
phenomenon, are often followed by very painful and difficult-to-heal digital ulcers (ulcers of the
fingers and toes). Current pharmaceutical treatments are often ineffective and may have safety and
The randomized, placebo-controlled, double-blind Phase II study investigates the safety of GS-248
and its efficacy on Raynaud’s phenomenon and peripheral vascular blood flow in patients with
systemic sclerosis. In total, 69 patients have been recruited to the study. Patients receive GS-248, or
placebo, orally once daily for four weeks.
Professor Ariane Herrick, Division of Musculoskeletal and Dermatological Sciences, The University of
Manchester, is Coordinating Investigator for the study, which is conducted at clinical sites in four
European countries. The study results will constitute an important basis and milestone in the
planning of the continued development program in systemic sclerosis and will also provide valuable
information on further opportunities for GS-248 in other inflammatory diseases.
“Through a strong effort by our clinical team and dedicated investigators, all patients needed to
complete the study have now been included in the Phase II study of GS-248 even though recruitment
was initiated in the midst of the covid-19 pandemic. We are looking forward to obtaining the results
from the study and to the continued development of our candidate drug, GS-248, in a disease area
where there is a large unmet medical need currently lacking adequate treatment”, comments
Gesynta Pharma’s CEO, Patric Stenberg.
GS-248 has a unique and promising mode of action which could bring relief to patients with systemic
sclerosis, as well as to patients with other chronic inflammatory diseases, by reducing inflammation
and increasing blood flow in the microvessels. This is achieved through potent and selective
inhibition of the microsomal prostaglandin E synthase-1 enzyme (mPGES-1). In April 2022, Gesynta
Pharma announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug
Designation to GS-248 for the treatment of systemic sclerosis.
For more information, please contact:
Patric Stenberg, CEO
Gesynta Pharma AB
Tel: + 46 (0)733 83 66 70
E-mail: [email protected]