Gesynta Pharma initiates clinical phase I study with GS-248 for the treatment of microvascular disease

Solna, Sweden - July 9th, 2019 - Gesynta Pharma AB ("Gesynta") announces that the first clinical study with GS-248 has been initiated and that the first healthy volunteers have been dosed. The purpose of the phase I study is to study safety, tolerability and pharmacokinetic properties of GS-248 as well as its effect on relevant biomarkers.

Gesynta's lead candidate drug, GS-248, is a potent and selective inhibitor of microsomal prostaglandin E synthase-1 (mPGES-1). GS-248 elicits its effect through a mechanism that provides combined anti-inflammatory, vasodilatory and platelet inhibitory effects. This enables evaluation for the treatment of several cardiovascular diseases. GS-248 is initially being developed for treatment of microvascular diseases in chronic inflammatory conditions.
The study with GS-248 has a randomized, double-blind design and will be conducted in multiple parts. The first part includes administration of GS-248 in single escalating doses to groups of healthy volunteers. In a second part, multiple doses of GS-248 will be administered for 10 days to new groups of subjects. After dosing to each group is completed, a safety assessment is conducted before continuing with subsequent group.
Clinical Trial Consultants (CTC) in Uppsala, a company with extensive experience in clinical development focusing on early trials, has been contracted to perform this study.

"The start of a phase I study with our first clinical candidate, GS-248, represents an important milestone for Gesynta Pharma and our ambition to develop new effective treatments for microvascular disease where there still exist large unmet medical needs." says Patric Stenberg, CEO of Gesynta Pharma.

For further information, please contact:
Gesynta Pharma AB Patric Stenberg, CEO Tel: + 46 (0)733 836670 E-mail: [email protected]

About Gesynta Pharma AB
Based on research from Karolinska Institutet, Gesynta leverages expertise in arachidonic acid research to explore the use of mPGES-1 inhibition in cardiovascular diseases and cancer. The clinical candidate, GS-248, is an oral small molecule being developed for the treatment of microvascular disease in chronic inflammatory conditions. When strategically optimal, Gesynta will seek pharma partners to efficiently make the new therapies available to patients and to achieve the full commercial potential of its products. Gesynta is a privately held Swedish company located in Stockholm operating with a team of experts in the fields of mPGES-1 medical research, drug discovery and clinical and business development.

Gesynta is located in the Karolinska Institutet Science Park, Sweden and has received support from Karolinska Institutet Innovations AB, NovoNordisk Foundation, Swelife and Vinnova.

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