Addex Therapeutics has seen its shares down 15% on the news that it has had to delay a registrational study of its Parkinson’s disease candidate.
The trial, known as study 301, was of dipraglurant to treat levodopa-induced dyskinesia associated with Parkinson’s disease (PD-LID). The company says it has “been postponed” with no timelines in place for its restart because of the continued spread of COVID-19 in Europe and the U.S. (where the trials are being conducted).
It’s also pushing back its financials and conference call until April 8. This comes as its native Switzerland has seen cases shoot past 1,000 over the past few days, with the country closing schools and banning large crowds in an effort to stop the spread, which has widened dramatically over the past week.
Given that many of the patients for this trial are in a high-risk group for COVID-19, the biotech said it was simply the only choice to make given new government guidance.
“Sites are temporarily suspending on-site visits for monitors, vendors, and all other non-patient visitors and several sites have cancelled all non-essential patient visits,” said Roger Mills, M.D., chief medical officer of Addex.
“Priority is now rightly being placed on how to manage regular care for patients in the light of the increasing COVID-19 containment requirements. We care about the well-being of all PD patients and do not wish to have them make the additional visits to doctors’ offices that are required in a clinical study, putting them at increased risk of contracting COVID-19.”
Addex is conducting its trials with a CRO and said it will now work with it “to continue preparations to start the study as soon as it is appropriate to do so.”
This comes a day after Provention Bio said it was delaying a phase 3 trial in diabetes “out of an abundance of caution to protect patients, caregivers, clinical site staff, company employees and contractors.”