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Synartro prepares for first clinical trial of lead compound SYN321 for treatment of symptomatic knee osteoarthritis

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Synartro announced today that the company has submitted a clinical trial application to the Swedish Medical Products Agency and the Swedish Ethical Review Authority, for a phase 1/2a first-in-human clinical study of investigational drug candidate SYN321.

The objective of the clinical study is to evaluate safety and tolerability, systemic exposure and preliminary efficacy of SYN321 in patients with symptomatic knee osteoarthritis (OA). The phase 1/2a study will be conducted by Clinical Trial Consultants AB in Uppsala and is planned to start during 2023.

The lead candidate SYN321 is a joint injection treatment targeting knee OA. The compound combines diclofenac and hyaluronan, two widely used substances for treatment of OA. The unique binding enables a slow release of the two substances, resulting in prolonged reduction of inflammation and pain relief. Local administration means systemic side effects are reduced.​

SYN321 is addressing a huge unmet medical need and a broad patient population, targeting both the large group of OA patients today not receiving adequate pain relief and patients already in treatment with problems of systemic side-effects, thereby targeting a broad patient population.​

"We are excited to announce that our first clinical trial application has been submitted. This is a milestone for Synartro and for the development of SYN321 as treatment for symptomatic knee OA, and the result of the Synartro team’s hard work and commitment. Now we are awaiting feedback from the authorities in order to initiate the clinical trial." says Håkan Wickholm, CEO (acting).

For further information, please contact:

Synartro AB, Håkan Wickholm, CEO (acting). Tel: +46 (0)72 7172526. E-mail: hakan.wickholm@synartro.com

About Synartro AB

Synartro is a Swedish life science company developing local injection treatments to provide superior and sustained efficacy without systemic side-effects. This is achieved by combining our novel delivery technology with existing proven drugs. Our lead program focuses on a novel therapy using our compound SYN321 for the treatment of osteoarthritis (OA). This disease leaves up to 50% of patients without adequate pain relief.

In addition to the founders, major shareholders include life science investment company Linc AB.