- Tiny Australian biotech Innate Immunotherapeutics crashed on the Australian stock market Tuesday after announcing its multiple sclerosis drug failed to show any clinically meaningful benefit or statistical significance.
- Innate announced topline data from a Phase 2b study of MIS416 in patients with secondary progressive multiple sclerosis.
- The company intends to conduct further analysis of the data but said "it is unlikely the result will significantly change."
Most multiple sclerosis patients have the relapsing/remitting form of the disease, meaning they have an attack but then return to normal function afterwards. Eventually, virtually all of these patients will evolve and go into a state of constant decline, reaching the secondary progressive form of the disease.
There are currently no approved medications for this advanced form of the disease. It has been notoriously tricky for pharmaceutical companies to develop treatments that can help, and almost all of the MS drugs available are for the relapsing/remitting form.
The Food and Drug Administration recently approved Roche’s Ocrevus (ocrelizumab) for the treatment of both relapsing/remitting MS, as well as primary progressive MS, a rare form of the disease that is not characterized by attacks, but a lengthy decline.
Most analysts believe that Ocrevus is poised to change the market and will likely be used for the secondary progressive population as well.
Had Innate succeeded in this space, it would have been faced with a large market opportunity. But now that the company’s lead candidate has failed, it said it is evaluating next steps.
Notably, Republican Congressman Chris Collins was the largest stockholder in the company and reportedly incurred a paper loss of nearly $17 million. Several other members of Congress invested in the company following Collins' lead, including Health and Human Services Secretary Tom Price.