Bafiertam (monomethyl fumarate) / Thermo Fisher Scientific - LARVOL DELTA

Cycle Vita expands patient support in Multiple Sclerosis (MS) to include BAFIERTAM (monomethyl fumarate) delayed-release capsules (Businesswire) - "Cycle Pharmaceuticals Limited (Cycle) is pleased to announce that Cycle Vita is now available with BAFIERTAM, expanding its patient support services in MS, following the acquisition of Banner Life Sciences, LLC....From April 1, 2025 onwards, new patients starting BAFIERTAM therapy will have access to Cycle Vita, which provides individualized financial, product, process and clinical support to eligible patients. Existing patients, who started therapy before April 2025, will continue to be supported by Banner Patient Support, and migrated to Cycle Vita in partnership with their healthcare providers. Cycle is committed to supporting patients, and will work to ensure a smooth transition with no disruption to patients’ medication and care."

Reimbursement • Multiple Sclerosis

SIMPLE: Observational Study of Persistence on Bafiertam Treatment in Routine Clinical Practice (clinicaltrials.gov) - P=N/A | N=25 | Terminated | Sponsor: Banner Life Sciences LLC | N=100 ➔ 25 | Enrolling by invitation ➔ Terminated; Business decision

Enrollment change • Trial termination • CNS Disorders • Multiple Sclerosis

TREAT-MS: Traditional Versus Early Aggressive Therapy for Multiple Sclerosis Trial (clinicaltrials.gov) - P=N/A | N=900 | Active, not recruiting | Sponsor: Johns Hopkins University | Recruiting ➔ Active, not recruiting | Trial completion date: Aug 2025 ➔ Aug 2026 | Trial primary completion date: Aug 2025 ➔ Aug 2026

Enrollment closed • Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov) - P4 | N=800 | Active, not recruiting | Sponsor: The Cleveland Clinic | Trial primary completion date: Apr 2030 ➔ Jul 2027

Trial primary completion date • CNS Disorders • Multiple Sclerosis

DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov) - P4 | N=800 | Active, not recruiting | Sponsor: The Cleveland Clinic | Recruiting ➔ Active, not recruiting

Enrollment closed • CNS Disorders • Multiple Sclerosis

The Evolving Role of Monomethyl Fumarate Treatment as Pharmacotherapy for Relapsing-Remitting Multiple Sclerosis. (PubMed, Cureus) - "Several different drugs have been recently approved for use in modifying the course of the disease, including a group of medications known as fumarates (e.g., dimethyl fumarate, diroximel fumarate, monomethyl fumarate) that have been shown to be efficacious and relatively safe. In the present investigation, we review available evidence focused on monomethyl fumarate, also known as Bafiertam®, along with bioequivalent fumarates for the long-term treatment of relapsing-remitting multiple sclerosis."

Journal • Review • CNS Disorders • Immunology • Inflammation • Multiple Sclerosis

DELIVER-MS: Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMS (clinicaltrials.gov) - P4 | N=800 | Recruiting | Sponsor: The Cleveland Clinic | Trial completion date: Sep 2026 ➔ Sep 2030 | Trial primary completion date: Dec 2025 ➔ Apr 2030

Trial completion date • Trial primary completion date • CNS Disorders • Multiple Sclerosis

SIMPLE: Observational Study of Persistence on Bafiertam Treatment In Routine Clinical Practice (clinicaltrials.gov) - P=N/A | N=100 | Enrolling by invitation | Sponsor: Banner Life Sciences LLC

New trial • CNS Disorders • Multiple Sclerosis

Comparative pharmacokinetics and bioavailability of monomethyl fumarate following a single oral dose of Bafiertam® (monomethyl fumarate) versus Vumerity® (diroximel fumarate). (PubMed, Mult Scler Relat Disord) - "The mean MMF AUC and AUC were 14-17% higher after administration of Bafiertam® as compared to Vumerity® at their respective therapeutic doses under fasting conditions, however, this difference was not statistically or clinically significant. Although more clinical studies would be needed before making strong recommendations, results of this study may help with selecting appropriate fumarate products, especially when administering the product with food is clinically recommended."

Journal • PK/PD data • CNS Disorders • Multiple Sclerosis

Bioequivalence Study of Bafiertam 190 mg and Vumerity® 462 mg Delayed-Release Capsules in Fasting Healthy Subjects (clinicaltrials.gov) - P1; N=46; Completed; Sponsor: Banner Life Sciences LLC

Clinical • New P1 trial • CNS Disorders • Multiple Sclerosis

PERSIST: Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® From Dimethyl Fumarate (clinicaltrials.gov) - P=N/A; N=0; Withdrawn; Sponsor: Banner Life Sciences LLC; N=50 ➔ 0; Not yet recruiting ➔ Withdrawn

Clinical • Enrollment change • Trial withdrawal • CNS Disorders • Multiple Sclerosis

"$BIIB results an interesting part-not discussed-much are the Vumerity sales growing to 120m$, I am curious how Bafiertam (monomethyl-fumerate) is selling (by Banner life LLC/private). Maybe someone has IQVIA estimates or @evaluatevantage has some, @JacobPlieth, @ByMadeleineA ?" (@SnupSnus)

PERSIST: Observational Study in Patients With Relapsing-Remitting Multiple Sclerosis Switched to Bafiertam® From Dimethyl Fumarate (clinicaltrials.gov) - P; N=50; Not yet recruiting; Sponsor: Banner Life Sciences LLC

New trial • CNS Disorders • Multiple Sclerosis

Monomethyl Fumarate (MMF, Bafiertam) for the Treatment of Relapsing Forms of Multiple Sclerosis (MS). (PubMed, Neurol Int) - "Monomethyl fumarate (MMF, Bafiertam) is a recent addition to the arsenal available in the fight against MS and appears to be well-tolerated, safe, and effective. In this paper, we review the evidence available regarding the use of monomethyl fumarate (Bafiertam) in the treatment of relapsing-remitting MS."

Journal • Review • CNS Disorders • Cognitive Disorders • Immunology • Multiple Sclerosis • Pain

Pharmacokinetics and Bioavailability of Monomethyl Fumarate Following a Single Oral Dose of Bafiertam™ (Monomethyl Fumarate) or Tecfidera (Dimethyl Fumarate). (PubMed, CNS Drugs) - P1 | "Based on the statistical analysis results of the pharmacokinetic parameters of MMF, a single oral dose of two Bafiertam™ DR 95 mg capsules is bioequivalent to a single oral dose of one Tecfidera DR 240 mg capsule."

Journal • PK/PD data • CNS Disorders • Multiple Sclerosis

Emerging Therapeutic Applications for Fumarates. (PubMed, Trends Pharmacol Sci) - "Here, we summarize the rapidly expanding literature on the pharmacokinetics and pharmacodynamics of fumarates, including a discussion on two recently FDA-approved fumarates Vumerity and Bafiertam. We review emerging applications of fumarates, focusing on neurological and cardiovascular diseases."

Journal • Review • Atherosclerosis • Cardiovascular • CNS Disorders • Dermatology • Dyslipidemia • Immune Modulation • Immunology • Inflammation • Multiple Sclerosis • Neuralgia • Pain • Peripheral Neuropathic Pain • Psoriasis • Reperfusion Injury

Comparative Bioavailability of BAFIERTAM™ (Monomethyl Fumarate) and Tecfidera® (Dimethyl Fumarate) in Healthy Subjects (clinicaltrials.gov) - P1; N=50; Completed; Sponsor: Banner Life Sciences LLC

Clinical • New P1 trial • CNS Disorders • Multiple Sclerosis

Banner Life Sciences Announces Commercial Launch of BAFIERTAM, a Novel Oral Fumarate Treatment for Relapsing Forms of Multiple Sclerosis (Businesswire) - "Banner Life Sciences LLC (Banner)...announced that BAFIERTAM™ (monomethyl fumarate), a novel fumarate for adults for the treatment of relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, will be commercially available in the U.S. September 1, 2020. BAFIERTAM was approved by the U.S. Food and Drug Administration (FDA) on April 28, 2020."

Launch US • CNS Disorders • Multiple Sclerosis

Monomethyl fumarate has better gastrointestinal tolerability profile compared with dimethyl fumarate. (PubMed, Mult Scler Relat Disord) - "Bafiertam showed an improved gastrointestinal tolerability profile compared with Tecfidera, with less severe GI events and fewer days of self-assessed GI symptoms, fewer GI adverse events, and lower discontinuation rates because of GI adverse events."

Journal • CNS Disorders • Multiple Sclerosis • Pain

Study to Compare GI Tolerability Following Oral Administration of Bafiertam™ or Tecfidera to Healthy Volunteers (clinicaltrials.gov) - P1; N=210; Completed; Sponsor: Banner Life Sciences LLC; Recruiting ➔ Completed

Clinical • Trial completion