By Fineline Cube 
Roche Holding AG (SWX: ROG, OTCMKTS: RHHBY) reported that both pivotal Phase III trials of its oral Bruton’s tyrosine‑kinase (BTK) inhibitor fenebrutinib have met their primary endpoints in two distinct forms of multiple sclerosis (MS).
Trial 1 – FENhance 2 (Relapsing MS)
| Parameter | Detail |
|---|---|
| Study Design | Randomised, double‑blind, active‑comparator (teriflunomide) |
| Population | Patients with relapsing‑remitting MS (RMS) |
| Duration | ≥ 96 weeks of continuous treatment |
| Primary Endpoint | Annualised Relapse Rate (ARR) reduction |
| Result | Statistically significant ARR reduction vs. teriflunomide (p < 0.001) |
| Safety | Liver‑enzyme profile consistent with earlier fenebrutinib data; no new safety signals identified |
| Status | Data under further safety review; submission to regulatory agencies planned for 2026 |
Trial 2 – FENtrepid (Primary‑Progressive MS)
| Parameter | Detail |
|---|---|
| Study Design | Randomised, double‑blind, active‑comparator (ocrelizumab – OCREVUS) |
| Population | Patients with primary‑progressive MS (PPMS) |
| Duration | ≥ 120 weeks of treatment |
| Primary Endpoint | Time to composite confirmed disability progression (CDP) |
| Result | Non‑inferior to ocrelizumab; early numerical advantage for fenebrutinib observed at week 24 and sustained through week 120 |
| Safety | Comparable adverse‑event profile to ocrelizumab; no increase in serious infections or hepatic events |
| Implication | First oral BTK inhibitor to demonstrate parity with the only approved PPMS therapy |
Fenebrutinib – Mechanistic & Commercial Outlook
- Molecule: Oral, CNS‑penetrant, reversible, non‑covalent BTK inhibitor with an optimised pharmacokinetic (PK) profile enabling once‑daily dosing.
- Differentiation: High‑efficacy oral option for both RMS and PPMS, addressing an unmet need for disease‑modifying therapies that are not infused.
- Market Potential: Global MS market ≈ US$30 billion (2025); oral BTK class could capture > 15 % of RMS and PPMS shares if approved.
- Regulatory Path: Roche plans to file New Drug Applications (NDAs) in the U.S., EU, and Japan in H2 2026, leveraging existing safety data from earlier Phase II studies.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding Roche’s clinical development timeline, regulatory strategy, and commercial potential of fenebrutinib. Actual results may differ due to risks including clinical outcomes, regulatory approvals, and market acceptance.-Fineline Info & Tech