Roche Holding AG’s RHHBY subsidiary, Genentech, announced that it has initiated an innovative phase III study for its investigational medicine, fenebrutinib, in multiple sclerosis (MS) and primary progressive MS (PPMS). The company has also initiated a higher-dose phase III study on Ocrevus (ocrelizumab) to evaluate its impact on reducing disability progression in RMS and PPMS.
Genentech is initiating two phase IIIb studies — one in RMS (named MUSETTE) and one in PPMS (named GAVOTTE) — which will evaluate a higher Ocrevus dose compared with the currently approved 600 mg dose, both being evaluated at the twice-yearly (six-monthly) dosing schedule. The studies will evaluate the potential benefit of higher dose Ocrevus in further reducing disability progression in people living with both RMS and PPMS.
Further, the company announced that it has started a phase IV CHIMES study on Ocrevus, exclusively focused on disease insights and more tailored care for minority populations with MS.
We note that Ocrevus is already approved for treating PPMS. It is the first and only drug approved for treating relapsing MS, including relapsing-remitting MS and active, or relapsing, secondary progressive MS. The drug is approved as twice-a-year intravenous administration.
Roche’s stock has gained 7.9% in the year so far against the industry’s decline of 0.9%.
The phase III study evaluating Fenebrutinib includes two identical phase III studies in RMS (named FENhance 1 and FENhance 2) and one phase III study in PPMS (named FENtrepid). All three studies are targeting clinical disability progression and have a primary endpoint of 12-week composite confirmed disability progression (cCDP-12). Annualized relapse rate in the RMS studies will be the co-primary endpoint.Fenebrutinib is a dual inhibitor of both B-cell and myeloid lineage-cell activation, which may help suppress disease activity and slow disease progression by targeting both acute and chronic inflammatory aspects of MS, which will be studied in the phase III study.
There are many companies developing drugs for MS. Last month, the FDA granted approval to Novartis’ NVS ofatumumab, a novel B-cell therapy, to treat patients with RMS. Ofatumumab will be marketed by the brand name of Kesimpta. Biogen Inc. BIIB has a strong position in the MS market, backed by a wide range of products like Avonex, Tysabri, Tecfidera.
Zacks Rank & Other Stocks to Consider
Roche currently sports a Zacks Rank #3 (Hold).
Another favorably-placed stock in the healthcare sector isGlaxoSmithKline GSK, carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
GlaxoSmithKline’s earnings estimates have increased from $2.90 to $2.99 for 2020 and from $2.94 to $3.05 for 2021 over the past 60 days. Shares of the company have decreased 17% year to date.
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