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Emerging treatments + myelin repairResults from peopleDid not show the hoped-for effect

Phase 2

PIPE-307: the Phase 2 VISTA study did not show the hoped-for benefit

Published by MyelinWatch:

Organisation
Contineum Therapeutics · United States

What happened

In relapsing-remitting MS, PIPE-307 had acceptable safety and tolerability, but it did not reach the study's main or secondary measures of benefit.

What this means for people with MS

One of the most discussed drugs designed specifically to repair myelin did not show benefit in Phase 2. It is uncertain whether development for MS will continue.

About the approach studied in this programme: PIPE-307 / VISTA

PIPE-307 blocks the muscarinic M1 receptor. The proposed repair strategy is to release a brake on the maturation of oligodendrocyte precursor cells, which can become myelin-producing cells; this biological rationale does not by itself show that VISTA participants regrew myelin.

Approach source: Contineum Therapeutics — SEC-filed VISTA announcement ↗ Poon et al. — original experimental PIPE-307 paper ↗

What kind of evidence exists?
Initial public results from the company
How reliable is this source?
Strong for the initial result • official company filing, not a full paper reviewed by independent scientists

Related study or programme: PIPE-307 / VISTA →

Source: Contineum Therapeutics — official company statement filed with the US SEC ↗
Research event/source date
Published by MyelinWatch
Last substantive MyelinWatch update

Related substantive developments

Research event/source date:
Emerging treatmentsRegistered study in peopleStudy authorised in Greece; not a result

Phase 3 extension study authorised in Greece; recruitment not yet started

Frexalimab: Greece authorises the long-term Phase 3 extension study

Organisation: Sanofi · France

The EU Clinical Trials Information System (CTIS) shows that Greece authorised Sanofi's Phase 3 extension study LTS18002 (2026-525688-41-00) on 2 November 2026. Denmark, Portugal and Poland authorised it on the same day, after Belgium (30 October 2026) and Austria (1 November 2026); all six countries are listed as authorised with recruitment pending. The record plans 17 participants in Greece and lists four Greek hospitals: AHEPA University General Hospital of Thessaloniki, the University General Hospital of Ioannina, the General University Hospital of Larissa and the 401 General Military Hospital of Athens. The study will look at the long-term safety and tolerability of frexalimab, an experimental antibody, in people with multiple sclerosis (MS). It is open only to people who complete earlier frexalimab studies on the study drug, such as the Phase 3 studies FREXALT and FREVIVA. The estimated EU recruitment start is 15 February 2027.

Published by MyelinWatch:

What this means for people with MS

Authorisation means the study may proceed in Greece; it does not mean that it has started at any Greek hospital, that anyone has received treatment in it, or that frexalimab works. No Phase 3 results are available yet. People who are not already in a frexalimab study cannot join this extension, so it is not a way for other people with MS in Greece to receive frexalimab. Frexalimab is not an available treatment in Greece.

Read the update →Source: EU Clinical Trials Information System (CTIS), European Medicines Agency — official CTIS record ↗Source: ClinicalTrials.gov — FREXALT (NCT06141473), Phase 3, ongoing, not accepting new participants ↗ Source: ClinicalTrials.gov — FREVIVA (NCT06141486), Phase 3, ongoing, not accepting new participants ↗
Research event/source date:
Emerging treatmentsRegistered study in peopleStudy authorised in two EU countries; not a result

Phase 3 extension study authorised in two EU countries; recruitment not yet started

Frexalimab: long-term Phase 3 extension study authorised in Belgium and Austria

Organisation: Sanofi · France

The EU Clinical Trials Information System (CTIS) shows that Belgium authorised Sanofi's Phase 3 extension study LTS18002 (2026-525688-41-00) on 30 October 2026 and Austria on 1 November 2026. The study will look at the long-term safety and tolerability of frexalimab, an experimental antibody given into a vein or under the skin, in people with multiple sclerosis (MS). It is open only to people with relapsing MS or non-relapsing secondary progressive MS who complete earlier frexalimab studies on the study drug, including the Phase 3 studies FREXALT and FREVIVA. It plans 1,710 participants in total. Both countries are listed as authorised with recruitment pending; the estimated EU recruitment start is 15 February 2027.

Published by MyelinWatch:

What this means for people with MS

Authorisation means the study may proceed; it does not mean that it has started, that anyone has received treatment in it, or that frexalimab works. No Phase 3 results are available yet. People who are not already in a frexalimab study cannot join this extension. Greece authorised the study later, on 2 November 2026 (see the separate update); frexalimab is not an available treatment in Greece.

Read the update →Source: EU Clinical Trials Information System (CTIS), European Medicines Agency — official CTIS record ↗Source: ClinicalTrials.gov — FREXALT (NCT06141473), Phase 3, ongoing, not accepting new participants ↗ Source: ClinicalTrials.gov — FREVIVA (NCT06141486), Phase 3, ongoing, not accepting new participants ↗
Research event/source date:
Emerging treatmentsResults from peopleSubgroup finding: significant in Hispanic or Latino participants, not significant in Black participants

Post hoc analysis of two completed Phase 3 trials in relapsing MS

OPERA trials: post hoc look at disability worsening in Black and Hispanic or Latino participants

Organisation: Keck School of Medicine, University of Southern California, with Genentech and Roche · United States

Researchers led by the University of Southern California, with authors from Genentech, Roche and other US centres, re-analysed the OPERA I and II trials, which compared ocrelizumab with interferon beta-1a for two years in relapsing multiple sclerosis (MS). In the interferon group, non-Hispanic Black and Hispanic or Latino participants had a higher risk of disability worsening confirmed after 24 weeks, measured with a combined (composite) disability measure, than non-Hispanic White participants (hazard ratio 3.0 and 2.3). Non-Hispanic Black and Hispanic or Latino participants also had more CD19-positive B cells at the start. In 1,138 participants who consented to genetic analysis, higher African or Americas genetic ancestry was also linked to higher risk. Ocrelizumab lowered B cells in all groups. Compared with interferon, it lowered the risk of this composite disability worsening in Hispanic or Latino participants (hazard ratio 0.38; 95% confidence interval 0.20–0.72). In the 65 Black participants the estimate also pointed to lower risk (hazard ratio 0.41), but the 95% confidence interval of 0.13–1.29 includes no difference, so the result is not statistically significant.

Published by MyelinWatch:

What this means for people with MS

This is not a new treatment or a new approval: ocrelizumab is already an approved MS treatment. The analysis was done after the trials ended, in small subgroups (only 65 Black participants), using self-reported race and ethnicity; it cannot show why risk differed and does not change treatment guidance. The authors conclude that ocrelizumab reduced risk regardless of race or ethnicity, but for Black participants the study alone does not establish this. It does not establish availability or reimbursement in Greece or support changing an individual treatment without a neurologist.

Read the update →Source: Multiple Sclerosis Journal (SAGE) — peer-reviewed primary article ↗Source: Multiple Sclerosis Journal — DOI 10.1177/13524585261496124 ↗ Source: ClinicalTrials.gov — OPERA I (NCT01247324), completed with posted results ↗ Source: ClinicalTrials.gov — OPERA II (NCT01412333), completed with posted results ↗