Mallinckrodt stopped the risk of pneumonia in the middle of the Acthar trial

Mallinckrodt announced that it would permanently discontinue Acthar's Phase IIb study, which aims to assess the efficacy and safety of Acthar Gel as a research treatment for amyotrophic lateral sclerosis (ALS).
The company decided to discontinue the trial after careful consideration of the latest recommendations of the independent Data and Safety Monitoring Board (DSMB), which was created in line with industry best practices to ensure the safety of patients involved in clinical studies.

the discontinuation of the trial was a particular problem with pneumonia, with a higher risk of ALS patients receiving Acthar Gel than patients receiving a placebo; The committee also referred to other adverse events specific to the patient population.
The Safety Monitoring Committee noted that the proportion of patients who had completed week 36 (the main endpoint target) excluded certainty as to the effectiveness of treatment. The committee made recommendations on the lack of clear signs of efficacy and the potential risk of pneumonia in the ALS patient population.
“ Mallinckrodt's primary concern is patient safety, and while ALS patients are the most in need of new treatments and treatment options, we believe this is the right decision. However, it is critical that these findings do not affect Acthar's current positive benefit/risk profile for current labeling adaptations," said Steven Romano, Executive Vice President and Chief Scientific Officer of Mallinckrodt.
He continued, "Although the likelihood of success in the ALS population is considered low, this study is based on a compelling analysis that was carried out after the completion of a small pilot study, and we hope it will benefit from this." This group of patients is in great need of effective treatment. We thank the Safety Monitoring Board, the researchers and the patients involved in the study. Als
is an aggressive neurodegenerative disease that affects motor neuron cells in the brain and spinal cord. Motor neurons reach the muscles of the body from the brain and spinal cord. The aggressive degeneration of motor neurons in ALS eventually leads to their death, and when motor neurons die, voluntary and involuntary muscle movement is lost.
With the gradual loss of motor neurons, people with ALS may lose the ability to talk, eat, move and breathe. （cyy123.com）