Denali Therapeutics Inc. DNLI initiated dosing in a global mid-stage study, BEACON, on BIIB122 (DNL151).

BIIB122, an investigational drug leucine-rich repeat kinase 2 (LRRK2) inhibitor, is being evaluated in participants with LRRK2-associated Parkinson’s disease (LRRK2-PD).

Shares of DNLI have risen 8.7% year to date against the industry’s 8.4% decline.

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More on DNLI’s Study on BIIB122

The phase IIa study will evaluate safety and biomarkers associated with oral daily dosing of BIIB122 in approximately 50 participants with Parkinson’s disease and LRRK2 pathogenic mutations confirmed by genetic testing.

The study is designed to enroll participants into a double-blind treatment period of three months followed by an open-label extension.

Denali holds the investigational new drug application for this phase IIa study and is leading its design and execution.

This study is being funded under a collaboration and development funding agreement between Denali and a third party.

In January 2024, Denali entered into a funding agreement with an unrelated third party, whereby this third party will provide up to $75 million of funding and collaborate to conduct a global phase IIa study of BIIB122/DNL151 in patients with Parkinson’s disease and confirmed pathogenic variants of LRRK2.

BIIB122 is also being evaluated in the ongoing global phase IIb LUMA study in participants with early-stage Parkinson’s disease with or without a LRRK2 mutation, in collaboration with Biogen BIIB.

The LUMA study is being conducted by Biogen. This study is expected to enroll approximately 640 participants with early-stage Parkinson’s disease, including eligible participants with LRRK2 mutations.

DNLI Makes Encouraging Pipeline Progress

Denali has two wholly-owned, late-stage development programs, DNL310 for Hunter syndrome and DNL343 (eIF2B activator) for amyotrophic lateral sclerosis (ALS).

DNL310 or tividenofusp alfa is an Enzyme Transport Vehicle (ETV) enabled iduronate-2-sulfatase (IDS) replacement therapy in development for MPS II (Hunter syndrome).

In September, Denali announced that its meeting with the FDA's Center for Drug Evaluation and Research (“CDER”) division to advance DNL310 was successful.

The meeting with CDER outlined a path for Denali to file a biologics license application (BLA) seeking accelerated approval of tividenofusp alfa (DNL310) for the treatment of MPS II and its subsequent conversion to full approval.

Denali agreed with the CDER that cerebrospinal fluid heparan sulfate (CSF HS) is reasonably likely to predict clinical benefit and can be used as a surrogate endpoint to support accelerated approval for tividenofusp alfa in MPS II.

The company plans to submit the BLA under the accelerated approval pathway in early 2025.

DNL343, an eIF2B activator, is being evaluated in a phase II/III HEALEY study to treat ALS. Enrollment has been completed in Regimen G of the study.

Denali and partner Sanofi SNY are co-developing SAR443820/DNL788. Sanofi informed Denali that the K2 phase II study evaluating the safety and efficacy of oditrasertib (SAR443820/DNL788) on serum neurofilament light chain levels in participants with multiple sclerosis was discontinued. The decision was taken after the study did not meet the primary and key secondary endpoints.

We remind investors that Sanofi had earlier discontinued the development of SAR443820/DNL788 for the treatment of ALS, based on the results of the phase II HIMALAYA study, which did not meet the primary endpoint.

Meanwhile, Denali and partner Sanofi are also developing SAR443122/DNL758 (eclitasertib), a peripheralRIPK1 inhibitor, for the treatment of ulcerative colitis. Sanofi is currently conducting a phase II study on this candidate.

Denali also has multiple early-stage clinical and preclinical programs in its pipeline.

DNLI's Zacks Rank and Stock to Consider

Denali currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Spero Therapeutics SPRO, which currently sports a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.29. Estimates for 2025 loss per share have narrowed from $1.54 to 79 cents.

Spero Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average surprise of 94.42%.


 

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