Denali Therapeutics Inc (NASDAQ:DNLI) was informed via e-mail communication from the U.S. Food and Drug Administration that DNL919 (ATV:TREM2) Investigational New Drug (IND) application was placed on clinical hold.
Denali has now received a formal clinical hold letter and is moving forward to address the FDA's observations related to the preclinical toxicology assessment.
The Company will also provide the information requested to initiate clinical studies, including proposed changes to the clinical trial protocol, the informed consent form, and the investigator brochure.
Denali intends to update once a clear path forward has been established.
Said Chief Medical Officer Carole Ho, "The longer-term Phase 1/2 data, now up to approximately one year for Cohort A and six months for Cohort B, support DNL310 as a differentiated enzyme replacement therapy that rapidly normalizes CSF heparan sulfate and maintains improvement in CSF biomarkers of lysosomal function with weekly intravenous dosing."
"With additional patient data now available, we are also encouraged that we continue to see improvements in exploratory clinical outcomes in the majority of individuals as assessed after six months of open label DNL310 treatment.
"These data continue to support initiation of a potentially registrational Phase 2/3 study of DNL310 in the first half of 2022. We look forward to continued collaboration with the MPS II community to advance research and DNL310 as a potential treatment for affected individuals and their families."
DNLI shares are down two cents to $34.83 soon after Monday's opening.
