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Roche's (RHHBY) MS Drug Reduces Brain Lesions in Phase II Study
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Roche (RHHBY - Free Report) announced new data from the mid-stage study on an experimental candidate, fenebrutinib, for treating relapsing multiple sclerosis (“RMS”).
Fenebrutinib is an investigational oral, reversible and non-covalent Bruton’s tyrosine kinase (“BTK”) inhibitor that blocks the function of BTK.
The phase II, randomized, double-blind, placebo-controlled 12-week study, FENopta, is evaluating the efficacy, safety and pharmacokinetics of fenebrutinib in 109 adults aged 18-55 with RMS.
New data from the FENopta study in RMS show that fenebrutinib crosses the blood-brain barrier with the potential to act directly on the chronic inflammation related to multiple sclerosis (“MS”).
The candidate was shown to penetrate the brain and reduce brain lesions in RMS patients.
Brain penetrance was measured by the level of fenebrutinib in the cerebrospinal fluid of a subgroup of 11 patients with RMS. The mean fenebrutinib concentration was 43.1 ng/mL after 12 weeks of continuous treatment.
Results also showed that fenebrutinib was able to significantly reduce the total number of new T1 gadolinium-enhancing (T1 Gd+) brain lesions (markers of active inflammation) along with reducing the total number of new or enlarging T2-weighted (T2) brain lesions. These lesions represent the amount of disease burden or chronic lesion load.
Patients treated with fenebrutinib were four times more likely to be free from any new T1 Gd+ brain lesions and new or enlarging T2 brain lesions at weeks 4, 8 and 12 combined compared with the placebo arm.
The encouraging results increase the possibility that fenebrutinib partially slows MS disease progression by acting directly within the brain.
The safety profile of fenebrutinib was consistent with previous and ongoing fenebrutinib studies across more than 2,500 people to date.
The late-breaking data were featured in an oral presentation at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis).
Currently, an open-label extension of FENopta is ongoing. The phase III program includes two identical trials in RMS (FENhance 1 & 2) with an active teriflunomide comparator and one trial in primary progressive MS (FENtrepid), wherein fenebrutinib is being evaluated against Ocrevus (ocrelizumab).
Roche’s Ocrevus is approved for RMS and relapsing-remitting MS.
RHHBY’s stock has declined 9.6% in the year-to-date period against the industry’s growth of 8.5%.
Image Source: Zacks Investment Research
Its performance in the first half was decent, excluding COVID-19-related sales. New drugs, namely Ocrevus, Hemlibra, Evrysdi, Tecentriq and Vabysmo, boosted growth.
Roche’s Ocrevus faces competition from biotech giant Biogen’s (BIIB - Free Report) strong MS portfolio, which comprises Tysabri, Tecfidera, Vumerity, Avonex, Plegridy and Fampyra. Biogen’s Tysabri is one of the market-leading drugs for MS.
Approval of additional MS drugs will solidify Roche’s MS franchise and increase competition for Biogen’s MS drugs.
Loss estimates for Acadia for 2023 have narrowed to 37 cents from 41 cents in the past 60 days, while earnings estimates for 2024 are pegged at 67 cents per share. The stock has surged 45.3% so far this year.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share.
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Roche's (RHHBY) MS Drug Reduces Brain Lesions in Phase II Study
Roche (RHHBY - Free Report) announced new data from the mid-stage study on an experimental candidate, fenebrutinib, for treating relapsing multiple sclerosis (“RMS”).
Fenebrutinib is an investigational oral, reversible and non-covalent Bruton’s tyrosine kinase (“BTK”) inhibitor that blocks the function of BTK.
The phase II, randomized, double-blind, placebo-controlled 12-week study, FENopta, is evaluating the efficacy, safety and pharmacokinetics of fenebrutinib in 109 adults aged 18-55 with RMS.
New data from the FENopta study in RMS show that fenebrutinib crosses the blood-brain barrier with the potential to act directly on the chronic inflammation related to multiple sclerosis (“MS”).
The candidate was shown to penetrate the brain and reduce brain lesions in RMS patients.
Brain penetrance was measured by the level of fenebrutinib in the cerebrospinal fluid of a subgroup of 11 patients with RMS. The mean fenebrutinib concentration was 43.1 ng/mL after 12 weeks of continuous treatment.
Results also showed that fenebrutinib was able to significantly reduce the total number of new T1 gadolinium-enhancing (T1 Gd+) brain lesions (markers of active inflammation) along with reducing the total number of new or enlarging T2-weighted (T2) brain lesions. These lesions represent the amount of disease burden or chronic lesion load.
Patients treated with fenebrutinib were four times more likely to be free from any new T1 Gd+ brain lesions and new or enlarging T2 brain lesions at weeks 4, 8 and 12 combined compared with the placebo arm.
The encouraging results increase the possibility that fenebrutinib partially slows MS disease progression by acting directly within the brain.
The safety profile of fenebrutinib was consistent with previous and ongoing fenebrutinib studies across more than 2,500 people to date.
The late-breaking data were featured in an oral presentation at the 9th Joint ECTRIMS-ACTRIMS Meeting (European and Americas Committees for Treatment and Research in Multiple Sclerosis).
Currently, an open-label extension of FENopta is ongoing. The phase III program includes two identical trials in RMS (FENhance 1 & 2) with an active teriflunomide comparator and one trial in primary progressive MS (FENtrepid), wherein fenebrutinib is being evaluated against Ocrevus (ocrelizumab).
Roche’s Ocrevus is approved for RMS and relapsing-remitting MS.
RHHBY’s stock has declined 9.6% in the year-to-date period against the industry’s growth of 8.5%.
Image Source: Zacks Investment Research
Its performance in the first half was decent, excluding COVID-19-related sales. New drugs, namely Ocrevus, Hemlibra, Evrysdi, Tecentriq and Vabysmo, boosted growth.
Roche’s Ocrevus faces competition from biotech giant Biogen’s (BIIB - Free Report) strong MS portfolio, which comprises Tysabri, Tecfidera, Vumerity, Avonex, Plegridy and Fampyra. Biogen’s Tysabri is one of the market-leading drugs for MS.
Approval of additional MS drugs will solidify Roche’s MS franchise and increase competition for Biogen’s MS drugs.
Zacks Rank & Stocks to Consider
Roche currently carries a Zacks Rank #4 (Sell).
A couple of better-ranked stocks in the healthcare industry are Acadia Pharmaceuticals (ACAD - Free Report) and Dynavax Technologies (DVAX - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for Acadia for 2023 have narrowed to 37 cents from 41 cents in the past 60 days, while earnings estimates for 2024 are pegged at 67 cents per share. The stock has surged 45.3% so far this year.
Loss estimates for Dynavax for 2023 have narrowed to 23 cents from 56 cents in the past 90 days, while earnings estimates for 2024 are pinned at 3 cents per share.