Shares inSareum Holdings PLC (AIM:SAR) fell 21% on Friday after the Cambridge-based biotech halted a key toxicology study for its lead autoimmune treatment, SDC-1801, following unexpected safety findings.
The 16-week preclinical study, conducted by a third-party contractor, was terminated after animals in the control group, which received an inactive solution, exhibited a higher rate of adverse effects compared to those treated with the drug itself.
Sareum said this made it “highly unlikely” that the issues were linked to SDC-1801.
The study was designed to meet regulatory requirements ahead of phase II trials, expected to begin with psoriasis patients. Sareum said it is working with consultants and alternative providers to restart the programme and still expects to complete it using existing cash reserves.
A previous phase I trial in healthy volunteers showed no safety concerns and supported once-daily dosing.
Executive chairman Stephen Parker said the setback was “frustrating” but that early data suggested the findings were unrelated to the treatment.
The shares fell 4.22p to 15.68p.