BrainStorm Cell Therapeutics, a leading biotechnology company focused on developing innovative treatments for patients with neurodegenerative diseases, has announced a significant restructuring plan. The company will be laying off approximately 30% of its workforce in order to realign its resources for a new clinical trial for their promising ALS (Amyotrophic lateral sclerosis) drug, NurOwn.
With a current staff count of 44 employees as of June 30, BrainStorm’s decision to reduce its workforce was driven by a desire to allocate more resources towards the development and execution of a redesigned trial for NurOwn. The biotech company aims to optimize the trial design to meet the rigorous standards set by the Food and Drug Administration (FDA).
This announcement follows closely on the heels of BrainStorm’s recent application for approval of NurOwn, despite receiving a refusal-to-file letter from the FDA. The agency highlighted concerns about the drug’s effectiveness based on a previous study. In an effort to address these concerns and move forward, an advisory committee hearing was organized. During the hearing, panelists voted 17-1 that NurOwn did not demonstrate substantial evidence of effectiveness in the aforementioned study.
Brian Henley, BrainStorm’s Chief Executive Officer, expressed his optimism about the company’s ability to address the FDA’s concerns. “We remain committed to advancing treatment options for patients with ALS,” said Henley. “We believe that the restructuring and the planned clinical trial redesign will enable us to generate the robust data needed to demonstrate the efficacy and safety of NurOwn.”
BrainStorm’s decision to invest in a redesigned clinical trial highlights the company’s dedication to finding a viable treatment for ALS patients. ALS, also known as Lou Gehrig’s disease, is a devastating neurodegenerative disorder that affects nerve cells in the brain and spinal cord, leading to muscle weakness and impairment. Currently, there are limited treatment options available for this debilitating disease.
As BrainStorm Cell Therapeutics navigates through this transformative period, the company aims to emerge stronger, armed with a more robust trial design for NurOwn. Through their unwavering commitment to advancing ALS research and development, BrainStorm remains hopeful that their groundbreaking therapy will ultimately bring much-needed relief to those affected by this devastating disease.
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