Alkermes

October 30, 2019 News by Patricia Inacio, PhD

Vumerity Approved in US as Treatment for RRMS and Active SPMS

The U.S. Food and Drug Administration (FDA) has approved Vumerity (diroximel fumarate) for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive disease (SPMS). Vumerity (previously known as ALKS 8700) was developed by Alkermes…

November 29, 2017 News by Alice Melão, MSc

Alkermes, Biogen Partnering on Therapy for Relapsing Forms of Multiple Sclerosis

Alkermes and Biogen have begun working together on a compound known as ALKS 8700 as a potential treatment for relapsing forms of multiple sclerosis. Under the agreement, Alkermes will be responsible for obtaining regulatory approval of the drug, while Biogen will handle its marketing. ALKS is taken orally. The body quickly transforms it into a compound known as monomethyl fumarate that can counter MS. Aikermes designed it to have better features than Tecfidera (dimethyl fumarate) — in particular, fewer gastrointestinal side effects. The partnership gives Biogen worldwide marketing rights to ALKS 8700. Alkermes will receive a royalty on global sales. Aikermes is evaluating ALKS 8700's safety and effectiveness in what it has dubbed the EVOLVE-MS clinical trial program. It includes two Phase 3 trials that are comparing ALKS 8700 with Tecfidera in patients with relapsing-remitting MS, or RRMS. Preliminary results of the EVOLVE-MS-1 trial, which involved 580 patients, showed few gastrointestinal side effects from ALKS 8700. The most common adverse events in the first month of treatment were flushing, diarrhea, and a rash known as pruritus. Aikermes discussed the treatments safety, and patients' ability to tolerate it, at the 7th Joint ECTRIMS-ACTRIMS Meeting in Paris in October. The company is still recruiting participants for a second trial that will compare ALKS 8700 and Tecfidera's effect on the gastrointestinal system. The EVOLVE-MS-2 study will  be conducted at locations in several U.S. states and six sites in Poland. Alkermes expects to release initial findings from the trial in the first half of 2018.  

November 1, 2017 News by Alice Melão, MSc

#MSParis2017 – EVOLVE-MS-1 Interim Trial Data Shows Alkermes Therapy Safe for Treating Relapsing MS

Preliminary data from the Phase 3 EVOLVE-MS-1 trial shows that ALKS 8700 — an investigative therapy developed by Alkermes to treat relapsing forms of multiple sclerosis — has a good safety and tolerability profile. ALKS 8700 is an oral compound. Once inside the body, it is rapidly transformed into the therapeutic compound monomethyl fumarate (MMF). Although similar, this drug candidate was designed to offer features different than those achieved with the commercially available Tecfidera (dimethyl fumarate). Alkermes is currently assessing the safety and efficacy of ALKS 8700 in the EVOLVE-MS program, which includes two Phase 3 clinical trials in patients with relapsing-remitting MS. The EVOLVE-MS-1 is a two-year study being conducted in 107 U.S. and European research sites. It will evaluate the long-term safety of ALKS 8700 in some 930 RRMS patients. Interim data collected during the first month of treating 580 participants showed low incidence of GI adverse events, with no reports of serious events. The most common adverse side effects associated with the treatment were flushing, pruritus and diarrhea. Alkermes, which is based in Ireland, said additional results from the initial three months of treatment further supported the positive safety data of ALKS 8700, with only 2.3 percent of patients reporting serious adverse events and 3.7 percent having to stop treatment. The EVOLVE-MS-2 trial, being conducted at 48 U.S. sites, will compare the safety and efficacy of ALKS 8700 versus Tecfidera in RRMS patients. The study is still recruiting participants. Recent data of EVOLVE-MS-2 was also subject of a poster presentation at the ECTRIMS-ACTRIMS Meeting.

October 20, 2017 News by Patricia Silva, PhD

#MSParis2017 – Alkermes to Give Updates on ALKS 8700 Studies at ECTRIMS-ACTRIMS Meeting

Alkermes will showcase its work in developing a treatment that harnesses the effect of Tecfidera (dimethyl fumarate) for relapsing multiple sclerosis (MS), while lowering the risk of stomach problems at the 7th Joint ECTRIMS-ACTRIMS Meeting this month in Paris. The investigational drug, ALKS 8700, uses the same mechanism of action as Tecfidera. By building the molecule in a different way, however, the company expects it will show better tolerability. Once in the body, dimethyl fumarate turns into monomethyl fumarate (MMF), the molecule that actually impacts MS disease processes. But before giving rise to MMF, dimethyl can cause side effects in users, particularly gastrointestinal. In fact, stomach problem were what caused people in Tecfidera Phase 3 trials to stop the treatment. Alkermes uses a so-called prodrug approach to try to overcome this problem. By attaching a different compound to MMF — which breaks away from the molecule once in the body —  it is possible to deliver MMF with lesser gastrointestinal side effects, Phase 1 study data indicate. At the meeting, the company will present two posters on two clinical trials exploring ALKS 8700 in patients with relapsing-remitting MS. The first presentation, will describe a Phase 3 trial that aims to compare ALKS 8700 to Tecfidera in about 420 patients. The trial is primarily concerned with the drug’s safety, and will measure the occurrence and impact of gastrointestinal side effects in the two treatment groups. The presentation will only include descriptions of patients characteristics and study design, as outcomes are yet to be analyzed. Patients who complete the Phase 3 trial will be eligible to continue in an ongoing open-label, long-term safety study, called EVOLVE-MS-1, covered in the company’s second presentation. By March 3, 2017, the study had enrolled 543 patients. In addition to describing patient characteristics, researchers will present the rates of discontinuation caused by gastrointestinal adverse events within one month of starting the treatment.

August 28, 2017 News by Alice Melão, MSc

RRMS Patients Needed for Phase 3 Trial to Assess Adverse GI Effects of ALKS 8700 Therapy vs. Tecfidera

Alkermes is funding a Phase 3 clinical trial evaluating the effects of its ALKS 8700 therapy on the gastrointestinal tracts of relapsing-remitting multiple sclerosis (RRMS) patients, compared to Tecfidera (dimethyl fumarate), according to a news release by the National Multiple Sclerosis Society. ALKS 8700, an orally administrated form of monomethyl fumarate, is still…

March 20, 2017 News by Patricia Silva, PhD

Alkermes Begins Phase 3 Study of ALKS 8700 as Relapsing MS Treatment

Alkermes has started a Phase 3 clinical trial evaluating ALKS 8700, the oral monomethyl fumarate (MMF) prodrug it is developing for the treatment of relapsing forms of multiple sclerosis (MS). The multicenter, double-blind, active-controlled trial (NCT02634307) will examine whether the gastrointestinal tract can tolerate ALKS 8700 better than Tecfidera…

 

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