Shots:

• The P-I clinical study evaluates the safety- PK- and PD of single & multiple ascending doses of DNL343 in 95 healthy volunteers with ALS & other P-I studies assess SAR443820 for the same indication
• The results showed that DNL343 was generally well tolerated for ~14 days of dosing- dose-related increases in CNS distribution & PK profile support qd dosing- changes in biomarkers of the ISR were identified. SAR443820 demonstrated the robust target engagement at doses that were generally well tolerated
• SAR443820 has received FTD from the US FDA for ALS. The company plans to start the patients dosing in the P-Ib study of DNL343 for ALS in Q3’21 & launch the P-II HIMALAYA trial of SAR443820 in Q1’22

  | Ref: Denali Therapeutics | Image: PR Newswire