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Thursday, July 7, 2022

Alterity Commences Mid-Stage Neurodegenerative Disorder Study

Alterity Therapeutics 

 doses first subject in its Phase 2 clinical trial of lead candidate ATH434 in Multiple System Atrophy (MSA), a rare and highly debilitating Parkinsonian disorder.

The Phase 2 clinical trial is designed to investigate ATH434 in patients with early-stage Multiple System Atrophy (MSA).

The mid-stage study is expected to enroll approximately 60 adult patients to receive one of two doses of ATH434 or placebo.

David Stamler, M.D., Chief Executive Officer, said, "This is just the first step as we expect to expand enrolment in multiple regions over the second half of this year. We are grateful to the entire clinical team at the New Zealand Brain Research Institute whose efficiency and dedication to their patients supported this accomplishment."

Multiple System Atrophy (MSA) is a rare, neurodegenerative disease characterized by failure of the autonomic nervous system and impaired movement. The disease is similar to Parkinson's disease, MSA progresses more rapidly and causes profound disability.

https://www.benzinga.com/general/biotech/22/07/27973355/alterity-commences-mid-stage-neurodegenerative-disorder-study

Wainwright Believes Ayala's Initial Cancer Data Is Encouraging

 

  • Ayala Pharmaceuticals Inc 
    AYALA
     reported data from Part A of its Phase 2 (RINGSIDE) trial evaluating AL102 in patients with desmoid tumors on Tuesday. 
  • At 16 weeks, one of 13 patients treated with AL102 demonstrated an unconfirmed partial response, which HC Wainwright believes signals encouraging initial activity. 
  • HC Wainwright reiterated the Buy rating on the stock with a price target of $18.
  • The analyst says that Ayala's initial data is encouraging in the context of the clinical development landscape. 
  • Competitor SpringWorks Therapeutics Inc's  nirogacestat hadn't yet shown any responses during the 16-week timeframe. 
  • HC Wainwright awaits data on 
    • Disease control rate (DCR), as nirogacestat has shown 100% DCR in the Phase 2 trial on desmoid tumors.
    • Longer-term data for AL102 benchmarked to the 29% (5/17) responses observed by approximately 28 months in SpringWorks' Phase 2 trial.
    • Median progression-free survival as SpringWorks Phase 3 trial demonstrated a 71% reduction in the risk of progression vs. placebo.
    • Breakdown in patients treated by each of three dose levels could add context to Ayala's unconfirmed response.