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Ionis (IONS) Posts Encouraging Data From Amyloidosis Drug Study
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Ionis Pharmaceuticals (IONS - Free Report) announced positive top-line data fromthe 85-week analysis of the phase III NEURO-TTRansform study on its investigational anti-sense drug eplontersen in patients with hereditary transthyretin-mediated amyloid polyneuropathy (“ATTRv-PN"). The candidate is being developed in partnership with AstraZeneca (AZN - Free Report) .
The overall analysis of the data from the NEURO-TTRansform study showed that treatment with eplontersen continued to show a sustained reduction in transthyretin (“TTR”) concentration. It also continued to halt disease progression and improved quality of life, following an 85-week period.
The study met its first two co-primary endpoints of change in the modified Neuropathy Impairment Score +7 (“mNIS+7”) and Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (“Norfolk QoL-DN”), with statistical significance. The mNIS+7 measures disease progression, while the Norfolk QoL-DN is an instrument to assess the quality of life in diabetic polyneuropathy. The study also met its third co-primary endpoint of eplontersen exhibiting a statistically significant and clinically meaningful improvement in percent change in serum TTR concentration.
These results were also consistent with the positive 66-week analysis of the study reported in March.
A new drug application (NDA) was filed by Ionis and AstraZeneca with the FDA last December, seeking approval for eplontersen in ATTRv-PN. A final decision on this NDA is expected by this year’s end.
In the year so far, shares of Ionis have increased 10.6% against the industry’s 4.8% fall.
Image Source: Zacks Investment Research
AstraZeneca and Ionis entered a strategic collaboration last December to develop and commercialize eplontersen to treat TTR amyloidosis. AstraZeneca and Ionis are jointly responsible for developing and marketing the drug in the United States. However, AstraZeneca will have exclusive global rights to develop and commercialize the drug outside the country (excluding Latin America).
Apart from ATTRv-PN, Ionis and AstraZeneca also evaluating eplontersen as a potential treatment for amyloid transthyretin cardiomyopathy (ATTR-CM) in the phase III CARDIO-TTRansform study.
Other than AstraZeneca, Ionis has partnerships with many pharma giants like Biogen (BIIB - Free Report) and Novartis (NVS - Free Report) . These partnerships enable Ionis to enjoy diverse revenue streams, including commercial products and royalties and numerous sources of collaborative and R&D revenues.
Biogen and Ionis are collaborating on developing advanced treatments for neurological disorders. Ionis has licensed Spinraza to Biogen, which is approved for treating spinal muscular atrophy in pediatric and adult patients. While Biogen is responsible for commercializing Spinraza worldwide, Ionis receives royalties from Biogen on Spinraza’s sales.
The company is developing another pipeline candidate, pelacarsen, in collaboration with Novartis. Ionis and Novartis are evaluating pelacarsen in the ongoing phase III cardiovascular outcome study, HORIZON, in patients with established cardiovascular disease and elevated lipoprotein(a) or Lp(a). Novartis is responsible for leading the global development and commercialization activities for the candidate.
Image: Bigstock
Ionis (IONS) Posts Encouraging Data From Amyloidosis Drug Study
Ionis Pharmaceuticals (IONS - Free Report) announced positive top-line data fromthe 85-week analysis of the phase III NEURO-TTRansform study on its investigational anti-sense drug eplontersen in patients with hereditary transthyretin-mediated amyloid polyneuropathy (“ATTRv-PN"). The candidate is being developed in partnership with AstraZeneca (AZN - Free Report) .
The overall analysis of the data from the NEURO-TTRansform study showed that treatment with eplontersen continued to show a sustained reduction in transthyretin (“TTR”) concentration. It also continued to halt disease progression and improved quality of life, following an 85-week period.
The study met its first two co-primary endpoints of change in the modified Neuropathy Impairment Score +7 (“mNIS+7”) and Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (“Norfolk QoL-DN”), with statistical significance. The mNIS+7 measures disease progression, while the Norfolk QoL-DN is an instrument to assess the quality of life in diabetic polyneuropathy. The study also met its third co-primary endpoint of eplontersen exhibiting a statistically significant and clinically meaningful improvement in percent change in serum TTR concentration.
These results were also consistent with the positive 66-week analysis of the study reported in March.
A new drug application (NDA) was filed by Ionis and AstraZeneca with the FDA last December, seeking approval for eplontersen in ATTRv-PN. A final decision on this NDA is expected by this year’s end.
In the year so far, shares of Ionis have increased 10.6% against the industry’s 4.8% fall.
Image Source: Zacks Investment Research
AstraZeneca and Ionis entered a strategic collaboration last December to develop and commercialize eplontersen to treat TTR amyloidosis. AstraZeneca and Ionis are jointly responsible for developing and marketing the drug in the United States. However, AstraZeneca will have exclusive global rights to develop and commercialize the drug outside the country (excluding Latin America).
Apart from ATTRv-PN, Ionis and AstraZeneca also evaluating eplontersen as a potential treatment for amyloid transthyretin cardiomyopathy (ATTR-CM) in the phase III CARDIO-TTRansform study.
Other than AstraZeneca, Ionis has partnerships with many pharma giants like Biogen (BIIB - Free Report) and Novartis (NVS - Free Report) . These partnerships enable Ionis to enjoy diverse revenue streams, including commercial products and royalties and numerous sources of collaborative and R&D revenues.
Biogen and Ionis are collaborating on developing advanced treatments for neurological disorders. Ionis has licensed Spinraza to Biogen, which is approved for treating spinal muscular atrophy in pediatric and adult patients. While Biogen is responsible for commercializing Spinraza worldwide, Ionis receives royalties from Biogen on Spinraza’s sales.
The company is developing another pipeline candidate, pelacarsen, in collaboration with Novartis. Ionis and Novartis are evaluating pelacarsen in the ongoing phase III cardiovascular outcome study, HORIZON, in patients with established cardiovascular disease and elevated lipoprotein(a) or Lp(a). Novartis is responsible for leading the global development and commercialization activities for the candidate.
Ionis Pharmaceuticals, Inc. Price
Ionis Pharmaceuticals, Inc. price | Ionis Pharmaceuticals, Inc. Quote
Zacks Rank
Ionis currently carries a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.