Yesterday, December 10, Arctic Aurora LifeScience portfolio company TG Therapeutics announced positive outcomes from two Phase 3 studies including a total of more than 1000 patients with multiple sclerosis (MS). The studies compared TG’s novel drug candidate ublituximab with an established MS treatment (Sanofi’s Aubagio). At close, TG stocks had moved up 41% on the news.
While the root cause of MS is not fully understood, the disease is caused by an autoimmune reaction directed toward the central nervous system. The body’s own immune cells start attacking the protective tissue surrounding nerve cells, resulting is wide array of symptoms. Patients may experience spasticity (excess movement), muscle and joint stiffness, numbness, fatigue, bowel and bladder problems, and cognitive function loss. Symptoms and severity tend to become progressively worse during the course of the disease.
A majority of patients are diagnosed with relapsing-remitting form of MS whereby symptoms come and go. This is where TG are active, and the key endpoints in the studies now finalized were how many relapses that occurred during the 1,5 years of study time. Ublituximab inhibits CD20, a protein found on certain white blood cell that are involved in initiation of immune responses, thereby blocking the autoimmune response to the body’s own nervous system.
The announced data showed an annualized relapse rate of less than 0.1 (on average one in ten MS patients experienced one relapse per year of ublituximab treatment) which was a clear and statistically significant improvement over Aubagio with 50%-60% lower relapse rates. Notably the average annual relapse rate is also numerically stronger than other CD20 treatments available today in MS (although one should be careful when comparing numbers directly across different studies).
New York-based TG has previously mostly been highlighted for their cancer pipeline and CD20-targeting drugs can also be utilized in the treatment certain types of blood cancers. Another of TG’s compounds, umbralisib, looks likely to be US-approved during the first half of 2021 in two types of lymphomas. Earlier this year, TG announced that the combination of umbralisib and ublituximab was effective in a certain type of leukemia. With the news in MS, TG may now receive four drug approvals in the next 12-18 months.
TG is one of the fund’s holdings within the small mid cap biotech segment. TG stock is up more than 50% the last month and has given a good contribution to the fund’s outperformance lately.