Denali Presented Results of DNL343 and SAR443820 in P-I Clinical Studies for the Treatment of Amyotrophic Lateral Sclerosis at NEALS 2021

October 7, 2021 Auto Bot amyotrophic lateral sclerosis, Clinical Study, Clinical Trials, Denali, P-I 0

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

Click here to read full press release/ article | Ref: Denali Therapeutics | Image: PR Newswire

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