Denali-Sanofi’s ALS Candidate Falls Short in Mid-Stage Study

Denali and Sanofi have been working together since 2018, when they reached an agreement to collaborate on the development of medications for the treatment of neurological and autoimmune illnesses. Small compounds that target a protein known as RIPK1 were the primary focus of the deal, which required Denali to pay an upfront payment of $125 million.

As a consequence of that study, the drug for amyotrophic lateral sclerosis (ALS), also known as SAR443820 or DNL788, was developed. 

ALS is a rare neurological condition that can cause neurons in the brain and spinal cord linked to muscular action to degenerate, ultimately resulting in gradual paralysis and death.

Sanofi’s most recent earnings report revealed that the pharmaceutical company has designated the medicine for progression into Phase 3 research later this year. This decision was made contingent on the success of the Phase 2 research, the findings of which were only recently announced.

These plans are currently under scrutiny, despite the fact that Jefferies analyst Michael Yee stated in a letter to investors on Friday that prospects didn’t seem too bright.

The only thing that Denali mentioned was that Sanofi will release the study’s effectiveness and safety data at a “future scientific forum.” Denali did not specify whether or not the research and development of ALS technology would be terminated.

Despite the failure, Sanofi is still working to determine whether or not the medicine is effective in treating multiple sclerosis, another illness of the neurological system that involves nerve damage.

Denali is also conducting clinical trials for a different medication to treat ALS. In order to inhibit what is referred to as the “integrated stress response,” this candidate, which has been given the name DNL343, operates by stimulating a protein known as eIF2B. This reaction is said to be involved in the death of nerve cells, according to Denali.

Not only does this development deal a blow to Denali and Sanofi, but it also has a bearing on other endeavors that are now being carried out within the pharmaceutical sector. For example, the gene treatment developed by Sarepta Therapeutics for a condition that causes muscular atrophy was unsuccessful in achieving the primary objective of a confirmatory study. 

Similarly, the activist hedge fund MKT Capital did not succeed in attracting binding proposals for Aurinia Pharmaceuticals. Because of this, the corporation is currently reverting to the practice of share buybacks and cutting costs.

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