As Covid-related challenges weigh on patient recruitment, biotech scraps PhIIb/III Parkinson's program
More than two years after little Swiss biotech Addex Therapeutics postponed a Phase IIb/III trial indefinitely due to the then-nascent Covid-19 pandemic, it’s throwing in the towel.
As with two years ago, Covid was to blame.
“We took this decision because it was not feasible to continue the study at such a slow recruitment rate in the current environment. I’d like to emphasize that it was not dipraglurant related and we continue to believe in the potential of this compound as a treatment for PD-LID,” CEO Tim Dyer said in a statement.
Addex shares $ADXN on Nasdaq sunk about 47.5% in pre-market trading Friday.
The company had hoped to test dipraglurant, a negative allosteric modulator of mGlu5, as a potential treatment for the uncontrolled, involuntary movement associated with levodopa use in Parkinson’s patients. But these patients were also at high risk for Covid-19, which led to concerns about participation in clinical studies, according to Addex.
Coupled with staffing shortages and turnover within study sites, the company said patient recruitment took a big hit.
A clinicaltrials.gov posting noted an actual study start date last August, with a target enrollment of 140 patients and estimated completion in August 2023.
Founded in 2002, Addex is focused on orally available small molecule drugs that allosterically modulate targets for neurological disorders. While the dipraglurant program in Parkinson’s had been among its most advanced, it’s also developing a mGlu2 positive allosteric modulator to treat epilepsy in partnership with J&J’s Janssen, while Indivior licensed its GABAB positive allosteric modulator for substance use disorder.
“We now plan to focus on advancing our preclinical portfolio towards the clinic and pursuing strategic collaborations for selected programs, while we concurrently focus on delivering under our strategic partnership with Indivior,” Dyer added. “Our strategic partner, Janssen is also expected to deliver data from the Phase 2 study of ADX71149 in epilepsy patients in the fourth quarter of this year.”
