Spruce Biosciences to Announce Phase 1 and 2 Data of Tildacerfont at Endocrine Society’s 2021 Annual Meeting

Rhea-AI Summary

Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company, announced that it will present data from its Phase 1 and 2 trials of tildacerfont for classic congenital adrenal hyperplasia (CAH) at the ENDO 2021 Annual Meeting from March 20-23. Key presentations include results from a 12-week Phase 2 trial and assessments of steroid hormones during the study. Tildacerfont aims to provide a novel non-steroidal therapy, addressing a significant unmet need in CAH, which has lacked new treatments for about 50 years.

Positive

• Presentation of promising clinical data at ENDO 2021 could attract investor interest.
• Tildacerfont may become the first non-steroidal therapy for CAH, improving disease management.

Negative

• No commercial product is yet available, leaving uncertainty in market potential.
• High competition in the biopharmaceutical industry for rare disease treatments.

Spruce Biosciences, Inc. (Nasdaq: SPRB), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need, today announced that data from its Phase 1 and 2 program of tildacerfont for the treatment of classic congenital adrenal hyperplasia will be shared at the Endocrine Society’s 2021 Annual Meeting (ENDO 2021) taking place virtually from Saturday, March 20 to Tuesday, March 23.

Full ePoster presentation details are listed below, and the full preliminary program is available online at the ENDO 2021 website. The presentations will be on display in ENDO 2021’s virtual poster hall beginning on Saturday, March 20 at 8:00am PST / 11:00am EST.

Tildacerfont for the Treatment of Patients with Classic Congenital Adrenal Hyperplasia: Results From a 12-week Phase 2 Clinical Trial in Adults with Classic CAH

Presenter: Richard J. Auchus, MD, PhD
Co-Authors: Richard J. Auchus, MD, PhD, Deborah P. Merke, MD, MS, Ivy-Joan Madu, MD, Samer Nakhle, MD, Kyriakie Sarafoglou, MD, Michael Huang, MD, David Moriarty, PhD, Chris N. Barnes, PhD, and Ron S. Newfield, MD
Poster Session: P25, Endocrine Disrupting Compounds: Mechanisms of Action and Clinical Implications
Abstract Number: 4308

Assessment of Steroid Hormones in Both Saliva and Blood During a Phase 2 Clinical Trial for the Use of Tildacerfont in Adults with Classic Congenital Adrenal Hyperplasia

Presenter: Chris N. Barnes, PhD
Co-Authors: Brian Keevil, MSc FRCPath, Kyriakie Sarafoglou, MD, David Moriarty, PhD, Michael Huang, MD, Chris N. Barnes, PhD, and Wiebke Arlt, MD DSc FRCP FMedSci
Poster Session: P54, Hormone Actions in Tumor Biology: From New Mechanisms to Therapy
Abstract Number: 4305

Dose Escalating and Bioavailability Phase 1 Studies Assessing Safety and Tolerability and Pharmacokinetics of Tildacerfont, A Small-Molecule Oral CRF1 Receptor Antagonist

Presenter: Chris N. Barnes, PhD
Co-Authors: Chris N. Barnes, PhD, Elliot Offman, PhD, Nora Darago, BS, and David Moriarty, PhD
Poster Session: P04, Adrenal - Basic and Translational Aspects
Abstract Number: 4140

About Spruce Biosciences

Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for rare endocrine disorders with significant unmet need. Spruce is initially developing its wholly-owned product candidate, tildacerfont, as the potential first non-steroidal therapy to offer markedly improved disease control and reduce steroid burden for patients suffering from classic congenital adrenal hyperplasia (CAH). Classic CAH is a serious and life-threatening disease with no known novel therapies approved in approximately 50 years.

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FAQ

What is tildacerfont and its purpose in treating CAH?

Tildacerfont is a potential non-steroidal therapy aimed at improving disease control for patients with classic congenital adrenal hyperplasia.

When will Spruce Biosciences present data on tildacerfont?

Data from the Phase 1 and 2 trials of tildacerfont will be presented at the ENDO 2021 Annual Meeting from March 20 to 23.

What are the key trial results being presented for tildacerfont?

Key results include findings from a 12-week Phase 2 clinical trial assessing the treatment's efficacy and safety.

How does tildacerfont differ from existing CAH treatments?

Tildacerfont aims to be the first non-steroidal treatment for CAH, reducing the reliance on steroid therapies.

What is the significance of the ENDO 2021 presentation for Spruce Biosciences?

The presentation may validate the safety and efficacy of tildacerfont, potentially impacting investor confidence and stock performance.