Novel Progressive Multiple Sclerosis Drug Selected for Grant

The investigational drug TGR-1202 (umbralisib) was selected for funding from the National Multiple Sclerosis Society to support its development through its not-for-profit subsidiary Fast Forward LLC.

TGR-1202 is a novel PI3K-delta inhibitor designed as a potential oral treatment for progressive forms of multiple sclerosis (PMS), according to a press release. The drug was selected through a competitive selection process.

Under the Sponsored Research Agreement, Fast Forward will provide funding to TG Therapeutics to further preclinical development of TGR-1202. The research will be led by Lawrence Steinman, MD, of Stanford University.

“We are extremely pleased to announce this research collaboration with the National Multiple Sclerosis Society and Dr Lawrence Steinman to explore the use of TGR-1202 in pre-clinical models of progressive forms of MS,” Michael S. Weiss, executive chairman and CEO of TG Therapeutics, said in the release. “Our long-term vision has always included developing TGR-1202 in autoimmune diseases and it is research collaborations like this one that will help us identify the most appropriate targets for clinical evaluation.”

TG Therapeutics focuses on the acquisition, development, and commercialization of novel treatment for B-cell malignancies and autoimmune diseases, according to the release.

“The recent approval of ocrelizumab has proven that B-cell targeted therapy is a very attractive treatment option for progressive MS patients as well as those with relapsing MS,” Lawrence Steinman, MD, George A. Zimmermann professor and professor of Pediatrics, Neurology, and Neurological Sciences at Stanford University, said in the release. “Umbralisib is a B-cell targeting agent that inhibits PI3K-delta, and enzyme that is essential for B-cell maturation and growth, providing a novel mechanism of action in treating patients with MS. We look forward to evaluating umbralisib’s effect on our preclinical progressive MS models in hopes to move umbralisib closer to clinical development in MS.”

The biopharmaceutical company is also developing the novel drug TG-1101 (ublituximab), which is designed to target a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes.

“We are hopeful that these proof of concept studies will support the rationale for further clinical development of TGR-1202 for progressive forms of MS, for which there are few treatment options,” Mark Allegretta, PhD, associate vice president of Commercial Research at the Society, said in the release. “TG Therapeutics is clearly committed to finding solutions for people with MS and we are pleased to work with a partner with the credibility and experience to carry this project forward. This exemplifies our effort to identify clinic-ready drug candidates to expand the pipeline of therapies being tested for use in MS.”