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Biogen (BIIB), Ionis to End Early-Stage ALS Candidate Development

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Biogen BIIB and partner Ionis Pharmaceuticals IONS announced disappointing top-line results from a phase I study evaluating their investigational antisense drug, BIIB078, in C9orf72-associated amyotrophic lateral sclerosis (ALS).

The phase I study evaluated multiple-dose cohorts of BIIB078 against placebo in adults with C9orf72-associated ALS. Although the drug was well-tolerated in the study participants, it failed to demonstrate any clinical benefit. The study did not achieve any of its secondary efficacy endpoints, which were ALS Functional Rating Scale-Revised, Slow Vital Capacity, Hand-Held Dynamometry and the Iowa Oral Pressure Instrument, among other endpoints.

While there were no consistent differences between the BIIB078 and the placebo group in participants administered in the dose cohorts up to 60mg, a greater decline was observed across secondary endpoints in participants in the 90mg dose cohort who were administered the antisense drug compared to those who were given placebo.

Based on this outcome, BIIB and IONS decided to discontinue the development of BIIB078, including any extension studies. Nonetheless, the companies still plan to present data from the above study at a future medical meeting.

Shares of Biogen have declined 11.8% so far this year in comparison with the industry’s 13.3% fall.

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Zacks Investment Research


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Conversely, shares of Ionis have risen 17.9% against the industry’s 14.6% decline during the same period.

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Zacks Investment Research


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Apart from BIIB078, Biogen has multiple other drugs undergoing clinical development targeting ALS indication, which include tofersen, BIIB105 and BIIB100. We note that tofersen was in-licensed by Biogen from Ionis as part of a collaboration and license agreement.

We remind investors that this is the second partnered candidate in ALS indication wherein both Biogen and Ionis have suffered a setback. Last October, both BIIB and IONS reported mixed data from a phase III study that evaluated tofersen in patients with SOD1-mutated ALS. While the study did achieve favorable trends across multiple secondary endpoints, it failed to achieve statistical significance in its primary endpoint. Both the partners are engaging with health regulators to determine tofersen’s future.

Apellis Pharmaceuticals APLS is also developing a treatment for ALS indication. Apellis Pharmaceuticals is evaluating its sole marketed drug, Empaveli (pegcetacoplan), in the phase II MERIDIAN study for the treatment of sporadic ALS. APLS expects to complete enrolment in the MERIDIAN study in first-half 2022. While Apellis is evaluating Empaveli in other indications including C3G and geographic atophy, the drug is currently approved as a monotherapy treatment for adult patients suffering from PNH.

Biogen’s collaboration with Ionis is part of a broad pipeline of partnered programs. Other than ALS, both the companies are also currently developing medicines to treat other neurodegenerative indications like spinal muscular atrophy (“SMA”) and Parkinson’s disease. In fact, Biogen’s blockbuster drug Spinraza, which is approved for treating SMA, was developed in collaboration with Ionis.

Biogen Inc. Price

Biogen Inc. Price
Biogen Inc. Price

Biogen Inc. price | Biogen Inc. Quote

Ionis Pharmaceuticals, Inc. Price

Ionis Pharmaceuticals, Inc. Price
Ionis Pharmaceuticals, Inc. Price

Ionis Pharmaceuticals, Inc. price | Ionis Pharmaceuticals, Inc. Quote

Zacks Rank & Stock to Consider

Both Biogen and Ionis carry a Zacks Rank #3 (Hold) at present. A better-ranked stock in the overall healthcare sector is Collegium Pharmaceutical COLL, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Collegium Pharmaceutical’s earnings per share estimates for 2022 have increased from $5.53 to $5.76 in the past 30 days. The same for 2023 has increased from $6.82 to $7.96 in the past 30 days. Shares of COLL have risen 5.4% year to date.

Earnings of Collegium Pharmaceutical beat estimates in three of the last four quarters and missed the mark on one occasion, with the negative surprise being 57.6%.


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