Vitalis will soon test VTS-72, a new formulation of fumarate and VTS-Aspirin, in a Phase 3 trial as a treatment for flushing — facial redness, itching or rash — in patients with relapsing-remitting multiple sclerosis (RRMS).
Flushing is a common side effect of an oral MS therapy called Tecfidera (dimethyl fumarate) that can cause pain and distress, and may lead to treatment discontinuation.
While Vitalis’s plans for a clinical trial have been previously reported, a recent Type C meeting with the U.S. Food and Drug Administration (FDA) has further supported the company’s strategy. In the November 2019 consultation, the two sides discussed the next steps for the development of VTS-72 in RRMS-related fumarate flush — namely the potential submission of a New Drug Application (NDA).
Tecfidera, marketed by Biogen, is an effective treatment option for people with RRMS, as it reduces disease relapses and slows disease progression. However, patients on Tecfidera often complain of flushing, a potentially severe facial redness, itching or rash, which may cause discomfort and distress. It has caused some patients to discontinue treatment.
Studies have shown that pretreatment with aspirin 30 minutes prior to fumarate-based therapy can significantly reduce flush. However, patient adherence to this regimen is low.
By combining VTS-Aspirin and fumarate, VTS-72 may enhance fumarate’s absorption, bioavailability, distribution, metabolism, and elimination in the body, all while reducing flush.
In a previous randomized, open-label study with 18 healthy subjects, VTS-72 was found to significantly reduce flush by 63.3%, compared with standard fumarate therapy. In addition, 39% of participants who had experienced flush with standard treatment reported no flush after taking VTS-72.
Vitalis now plans to launch a Phase 3 trial before the end of the year, and to pursue the approval of VTS-72 for the treatment of fumarate-related flush in RRMS patients.
“We had a very productive engagement with the FDA to determine the path forward for the development of VTS-72 in RRMS patients who experience fumarate flush,” Joseph Habboushe, MD, MBA, founder of Vitalis and inventor of the VTS platform, said in press release.
“Based on the feedback we received from the FDA, we expect to initiate a single pivotal trial this year and to submit an NDA in 2021 for our initial indication of acute flush reduction. This timeline aligns with a potential commercial launch of VTS-72 in this indication, if approved, in late 2021,” Habboushe added.
VTS-72 has already received orphan drug designation by the FDA as a potential treatment for people with MS who experience fumarate flush.
Vitalis also is exploring the possibility that its unique aspirin and fumarate combination may be superior to currently approved fumarate-based therapies in terms of relapse reduction in MS.
Further, the company is planning to extend VTS-72 clinical development to other MS-related indications, namely fatigue and exercise intolerance. It is believed that overheating may be a common cause of both MS fatigue and MS exercise intolerance, and studies have shown that aspirin can reduce fatigue and improve exercise performance in MS patients.
“Based on existing literature supporting the use of aspirin in MS, Vitalis aims to seek additional subsequent approvals in other MS-related indications,” Habboushe said. “We are excited by what the future holds for VTS-72.”