Press release from Companies

Published: 2020-12-15 14:03:03

Double Bond Pharmaceutical International AB: DBP International AB: Pharmacokinetic study of SI-053 in animals is completed

Double Bond Pharmaceutical International AB (publ) ("DBP", "Double Bond" or "Double Bond Pharmaceutical") announces positive results from its SI-053 in vivo pharmacokinetic study in rats.

SI-053 is Double Bond’s front-line product for local therapy of primary malignancies in the brain. In accordance with the recommendations from the European Agency of Medicines (EMA), DBP has evaluated the local and systemic distribution of temozolomide (TMZ) in the brain, cerebrospinal fluid (CSF) and plasma, and its metabolites after intracerebral injection of SI-053 in rats.

The results showed that after a single dose of SI-053:

•           Since SI-053 is applied locally in the brain, the availability of TMZ is increased, intracerebrally. Compared to the oral equivalent, TMZ in SI-053 does not need to pass the Blood Brain Barrier (BBB) to reach the site of action.

•           TMZ in SI-053 penetrates the brain tissue which allows the product to not only work at the application site, but also in the adjacent tissues.

•           Limited distribution from the brain to plasma/CSF indicates that SI-053 mainly acts locally which limits unnecessary systemic exposure to TMZ.

"We are delighted to have this study finalized. These PK results are very important as they confirm our expectations for local therapy, which will also help to predict the therapeutic outcomes’’ – comments Dr. Lili Li, Product Development Specialist at Double Bond Pharmaceutical.

"This is the fourth crucial milestone which not only supports the therapeutic concept of SI-053, but also supports the importance of moving into clinical trials to eventually benefit the patients. ’’- comments Igor Lokot, CEO of Double Bond Pharmaceutical.

10 communicated milestones between Q3 2020 to Q1 2021https://mb.cision.com/Main/12720/3191146/1304323.pdf
Milestone Comments Status
Preclinical: Efficacy of SI-053 in subcutaneous tumor in mice Finalized  Done
Preclinical: Biodistribution of SI053 after intracerebral administration in rats Finalized  Done
Preclinical: Toxicity studies of SI-053 after intracerebral administration in rats Waiting for finalization in Q1 2021
Clinical: Key Opinion Leader (KOL) meeting, an important milestone for SI-053 Phase 1 clinical study Finalized  Done
Clinical: Feasibility studies for clinical site selection for Phase 1 SI-053 clinical study Ongoing, to be finalized in Q4 2020
CMC: Sterilization of SI-053 will be validated Ongoing, to be finalized in Q4 2020
CMC: Stability study for SI-053 has been started Finalized  Done
CMC: The IMPD is completed Ongoing, to be finalized in Q1 2021
Regulatory: Clinical trial application (CTA) for Phase 1 SI-053 clinical study Q1 2021
Financing phase 1 Q4 2020

More about Temodex/SI-053: Temodex, which is a locally acting formulation of temozolomide developed by RI PCP in Minsk, Belarus, is registered for marketing as the first-line treatment of glioblastoma within Belarus since 2014. Temodex was acquired by DBP in autumn 2015 and is now being prepared under the name SI-053 to pass through all the tests and trials required for registration within the EU and globally. Video presentation: https://youtu.be/iweOQPq316o

Information about Double Bond Pharmaceutical International AB:

DBP is a pharmaceutical company with the primary focus on development of therapies against cancer based on the company’s own developed drug delivery technology BeloGal®. The company was granted Orphan Drug Designation status by European Medicines Agency (EMA) in June 2015 for its first product, SA-033, for treatment of hepatoblastoma. Double Bond Pharmaceutical acquired rights to Temodex, a drug registered in Belarus for treatment of brain tumours, in October 2015, and was granted Orphan Drug Designation status by EMA for in July 2016 for this formulation of temozolomide for the treatment of glioma. The formulation is now being further developed for registration in EU and globally and has a working name SI-053 in DBP pipeline.

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Full Company Name:   Double Bond Pharmaceutical International AB (publ)

Corporate identity:       556991-6082

Stock short name:       DBP B

Share ISIN code:          SE0007185525

For more info, contact

Igor Lokot, CEO

Homepage: http://www.doublebp.com/

E-mail: info@doublebp.com

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