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Synartro has been granted regulatory and ethical approval for the first clinical trial of lead compound SYN321 for treatment of symptomatic knee osteoarthritis

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Synartro announces that the company has been granted approval from the Swedish Medical Products Agency and the Swedish Ethical Review Authority to start the phase 1/2a first-in-human clinical study of the 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 turn of the year 2023/2024.

The lead candidate SYN321 is a joint injection treatment targeting knee OA. SYN321 is a new chemical entity (NCE) with a unique binding that enables a slow release of the active substance, with expectations of a prolonged reduction of inflammation and pain relief. Local administration means systemic side effects are reduced.​ SYN321 is partly built of diclofenac and hyaluronan, two widely used substances for treatment of OA.

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 we have obtained approval from the Swedish MPA and Swedish Ethical Review Authority to start the first clinical trial. This is a great milestone for Synartro and for the development of SYN321 as a treatment for symptomatic knee OA, and the result of the Synartro team’s hard work and commitment. The approval comes with condition to submit the general GMP manufacturer´s authorization for investigational medicinal products (IMP). Technical batches of SYN321 solution for injection have already been manufactured and stability data is currently available. The planned GMP production will be initiated shortly”, says Mia Brundin (CEO).

For further information, please contact:

Mia Brundin, CEO. Tel: +46 (0) 734 336 025. E-mail: mia.brundin@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 symptomatic 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.

Tags:

biotech osteoarthritis synartro SYN321

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