Neuraltus Pharmaceuticals has announced plans to initiate a second phase 2 study of its investigational treatment, NP001, in patients with amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease.
Under the proposed study funded by a recent equity financing from existing investors, Neuraltus aims to confirm the previous phase 2 clinical study findings in patients with elevated levels of baseline inflammation.
Neuraltus measured levels of C-reactive protein (CRP), a marker of systemic inflammation, from participating patients in the first phase 2 study.
Further analyses of this data indicate that increased levels of CRP, at baseline may indicate patients more likely to have a positive response to NP001.
ALS progression is considered to be driven partly by systemic inflammation and NP001 is designed to regulate inflammatory cell activity, as measured by CRP.
The company intends to start enrolling the second phase 2 study in North America in this year.
Neuraltus Pharmaceuticals chief executive officer Rich Casey said: "The recently secured equity financing allows us to advance the clinical development of NP001 in ALS.
"Progressive neurological diseases and disorders of the brain are often complex, life-threatening conditions, many of which have few if any treatment options.
"This second Phase 2 study is expected to generate additional data about NP001’s safety and efficacy to provide a clear clinical and regulatory path forward for this potential ALS treatment."
ALS is a rare and fatal neurodegenerative disease characterised by degeneration of motor neurons in the spinal cord and brain and currently no treatments are available that can slow the progression of or stabilise the disease.
Causes of the disease are still unknown, but there is increasing evidence that implicates neuroinflammation with progression of the disease.
There are currently an estimated 400,000 ALS patients worldwide.