Belgium – 28th September 2020 – Syndesi Therapeutics SA, a clinical stage biotechnology company developing novel modulators of the synaptic vesicle protein SV2A for the treatment of cognitive impairment, provides an update on the clinical development of its lead molecule, SDI-118, and announces an extension of its series A financing.

Following successful completion of a first in human single ascending dose and PET occupancy study of SDI-118, dosing in two additional Phase I studies has been completed and the data are being analyzed:

• A multiple ascending dose study to examine the safety, tolerability, and pharmacokinetics of SDI-118, following 14 days of dosing in healthy young and healthy elderly subjects.

• A single dose cross-over study investigating the effects of SDI-118 on EEG (electroencephalogram) recordings of brain activity

Results from both these studies are expected before the end of 2020.

Based on the promising progress to date, all Syndesi's existing investors - Novo Holdings, Fountain Healthcare, Johnson & Johnson Innovation – JJDC, Inc., SRIW, V-Bio Ventures and Vives Fund, together with UCB Ventures - have committed to an additional tranche of Series A financing to conduct a second clinical proof-of-principle study. This study will focus on remitted depressed subjects who report a perceived deficit in cognition. Concurrently a study in elderly subjects reporting memory problems will also be run. These studies are planned to commence during H1 2021.

Commenting on the progress made with SDI-118 development and the extended financing Jonathan Savidge, CEO of Syndesi, said “We continue to be encouraged by the profile of SDI-118 as a potential treatment for a number of CNS disorders with cognitive impairment. The additional financing demonstrates the commitment from our existing investors, and allows the company to conduct a second clinical proof of principle study to more fully explore the potential benefits of SDI-118. We look forward to our next important milestones: receiving the full results from the further Phase I studies, and then commencement of two clinical proof of principle studies


About Syndesi Therapeutics

Syndesi Therapeutics was established to develop a series of novel, pro-cognitive small molecule SV2A modulators licensed from UCB. Syndesi is investigating the potential of these molecules to improve cognition in diseases such as Alzheimer’s Disease and other dementias, as well as other conditions such as major depression and cognitive impairment associated with schizophrenia. The lead molecule, SDI-118, has successfully completed a First-in-Human Phase I study which demonstrated target engagement with PET imaging. The Phase I program has been supported in part by funding from the Walloon Region. The company is financed by a top tier syndicate of international and Belgian investors: Novo, Fountain Healthcare, Johnson & Johnson Innovation – JJDC, Inc., SRIW (Société Régionale d’Investissement de Wallonie), V-Bio Ventures and Vives Fund, along with UCB Ventures. Syndesi’s financing from its extended Series A round together with non-dilutive funding from the Walloon Region totals in excess of €26 M.