Spruce separates CRHX-101 programme into new endocrinology company Adrenyx Biosciences

Spruce Biosciences has separated its CRHX-101 programme into a newly formed subsidiary, Adrenyx Biosciences, as part of a plan to create two independent publicly traded biotechnology companies.

CRHX-101, previously known as SPR-202, is an investigational monoclonal antibody being developed for classic congenital adrenal hyperplasia.

Under the proposed structure, Adrenyx will operate as a dedicated endocrinology company focused on advancing CRHX-101, while Spruce will continue to concentrate on neurological disorders.

Spruce currently intends to distribute all outstanding shares of Adrenyx common stock to its existing shareholders on a pro rata basis.

The distribution is expected to take place during the first half of 2027, subject to final approval by Spruce’s board and other conditions.

Adrenyx has also secured a commitment of up to $50 million from a healthcare-focused investor to support development of CRHX-101.

The candidate is designed to selectively neutralise corticotropin-releasing hormone, or CRH, which is positioned upstream in the hormonal pathway driving excess adrenal androgen production in classic congenital adrenal hyperplasia.

By targeting this pathway, Adrenyx aims to develop a treatment that could provide more durable disease control and potentially reduce reliance on chronic high-dose steroid therapy.

Long-term steroid treatment used in congenital adrenal hyperplasia can be associated with complications including impaired growth, bone loss, metabolic effects and Cushingoid features.

Adrenyx’s near-term plans include completing investigational new drug-enabling nonclinical studies and chemistry, manufacturing and controls activities.

The company also plans to submit an Investigational New Drug application for CRHX-101 to the U.S. Food and Drug Administration and begin clinical development thereafter.

Samir Gharib, currently President and Chief Financial Officer of Spruce Biosciences, has been appointed President and Chief Executive Officer of Adrenyx.

He is expected to continue in that role following the planned separation while also remaining President and Chief Financial Officer of Spruce.

Additional members of the Adrenyx leadership team include Kirk Ways, MD, PhD, as Chief Medical Officer, Patrick Gearing, PhD, as Head of Chemistry, Manufacturing and Controls, and Meghan Bowler, PhD, as Project Team Leader.

Following the proposed distribution, Spruce will remain focused on developing treatments for neurological disorders.

Its lead programme is TA-ERT for mucopolysaccharidosis type IIIB, with a Biologics License Application submission planned for December 2026.

Spruce is also preparing for a potential U.S. commercial launch of TA-ERT in 2027 if the therapy receives approval.

Spruce’s board has not yet formally approved the Adrenyx distribution or established a record date.

Until the separation is completed, Adrenyx will remain a controlled subsidiary of Spruce.

 

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Related Topics and Keywords

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