Spruce Biosciences Launches Natural History Study for Congenital Adrenal Hyperplasia in Time for World Rare Disease Day

Study Aims to Support Patients, Improve Care, and Accelerate Research for Rare Disorder by Putting Power in Patients’ Hands

 

San Francisco – February 28, 2018 – Spruce Biosciences, a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders, today announced the launch of its CAH Natural History Study. The study will enable patients with congenital adrenal hyperplasia (CAH), a rare disease, to contribute their experiences to advance knowledge of the disease, including its management and treatment. Spruce is launching the study in conjunction with World Rare Disease Day, an annual observance to raise awareness about rare diseases and the impact of living with them on patients, families and caregivers.

Although CAH is part of the newborn screening program and highly identifiable –  unlike many other rare diseases – there are currently no FDA-approved therapies for CAH. The CAH Natural History Study is designed to collect health-related patient information and serve as a resource to advance education, advocacy, and research initiatives, as well as serve as a recruitment database that can be used to address the difficulties associated with enrolling patients into clinical trials necessary to advance the development of new therapeutics.

“World Rare Disease Day promotes awareness and support for people impacted by rare diseases. Our decision to launch the CAH Natural History Study in conjunction with this annual observance underscores our pledge to conduct research that generates real-world patient outcomes in CAH,” said Dr. Alexis Howerton, CEO, Spruce Biosciences. “We believe this research will help transform the collective understanding and approach to treating CAH, helping patients and families get optimal care for generations to come.”

CAH is a rare endocrine disorder caused by genetic mutations resulting in the inability to produce the critical ‘stress’ hormone, cortisol. The most common form of CAH, 21 hydroxylase deficiency, affects approximately 1 in 10,000 to 15,000 people in the United States.

Patients interested in participating in the CAH Natural History Study can visit the site here.

Spruce is currently conducting a Phase 2 clinical trial to assess the safety and efficacy of SPR001in adults with classic CAH. For more information on Spruce Biosciences and its lead clinical program for CAH, please visit sprucebiosciences.com.

About Spruce Biosciences

Spruce Biosciences is a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders. The Spruce team is leveraging their extensive expertise in endocrinology and orphan drug development to meet the significant unmet need of patients suffering from rare endocrine diseases. Spruce’s lead product candidate, SPR001, has a novel and clinically verified mechanism of action (MOA) and is currently in Phase 2 clinical trials for congenital adrenal hyperplasia, a rare disease that is screened in newborns and for which there is not yet an FDA-approved therapy. The Company is headquartered in San Francisco and closed a Series A Financing of $20 million in 2016. For more information on Spruce, please visit sprucebiosciences.com.

 

Media Contact
Amanda Guisbond
Canale Communications
781-405-8775
amanda@canalecomm.com


Spruce Biosciences Receives EMA Orphan Drug Designation for SPR001 for the Treatment of Congenital Adrenal Hyperplasia

Clinical-stage biotech granted orphan drug designation for the treatment of CAH, a rare endocrine disease

 

San Francisco – January 5, 2017 – Spruce Biosciences, a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders, today announced that the European Medicines Agency (EMA) has granted orphan drug designation for SPR001 for the treatment of congenital adrenal hyperplasia (CAH).

Earlier this month, Spruce also received orphan drug designation for SPR001 from the U.S. Food and Drug Administration (FDA). “The granting of orphan drug designation by both the EMA and FDA represents an important step forward for our lead product candidate, and underscores the high unmet medical need for developing new therapies that may benefit patients living with congenital adrenal hyperplasia,” said Dr. Alexis Howerton, CEO, Spruce Biosciences.

Spruce is currently in a Phase 2 clinical trial to assess the safety and efficacy of SPR001 in adults with classic CAH. This study is enrolling at centers across the U.S., with topline data expected in 2018. Patients interested in seeing if they may be eligible to participate can visit the clinical trial study site here.

About Spruce Biosciences

Spruce Biosciences is a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders. The Spruce team is leveraging their extensive expertise in endocrinology and orphan drug development to meet the significant unmet need of patients suffering from rare endocrine diseases. Spruce’s lead product candidate, SPR001, has a novel and clinically verified mechanism of action (MOA) and is currently in Phase 2 clinical trials for congenital adrenal hyperplasia, a rare disease that is screened in newborns and for which there is not yet an FDA-approved therapy. The Company is headquartered in San Francisco and closed a Series A Financing of $20 million in 2016. For more information on Spruce, please visit sprucebiosciences.com.

 

Media Contact
Amanda Guisbond
Canale Communications
781-405-8775
amanda@canalecomm.com


Spruce Biosciences Receives FDA Orphan Drug Designation for SPR001 for the Treatment of Congenital Adrenal Hyperplasia

Clinical-stage biotech granted orphan drug designation for the treatment of CAH, a rare endocrine disease

San Francisco – December 4, 2017Spruce Biosciences, a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for SPR001 for the treatment of congenital adrenal hyperplasia (CAH).

Earlier this year, Spruce initiated a Phase 2 clinical trial to assess the safety and efficacy of SPR001 in adults with classic CAH. This study is currently enrolling at centers across the U.S., with topline data expected in 2018. Patients interested in seeing if they may be eligible to participate can visit the clinical trial study site here.

“Receiving orphan drug designation is an important regulatory milestone, and we are pleased that SPR001 for CAH has been granted this status. We are developing SPR001 with the objective of providing individuals with CAH an effective treatment, and our team is committed to advancing the clinical development program to address this unmet need,” said Dr. Alexis Howerton, CEO, Spruce Biosciences.

CAH is a rare endocrine disorder that is caused by genetic mutations resulting in the inability to produce the critical ‘stress’ hormone cortisol. Although CAH is part of the newborn screening program, there are currently no FDA-approved therapies for CAH. CAH is typically treated with chronic, high-dose steroids which commonly leads to significant side effects and long-term health consequences.

“Treatments to improve the lives of CAH patients are of critical interest to CARES Foundation. We applaud the work of Spruce Biosciences in this space and look forward to continuing to collaborate with Spruce to provide patients with more options,” said Dina Matos, Executive Director, CARES Foundation. CARES is a non-profit organization dedicated to improving the lives of patients with CAH through community support, advocacy, education, and research.

The FDA grants orphan drug designation to promote the development of promising products for rare conditions that affect fewer than 200,000 people in the U.S. and for which significant unmet need remains. This designation provides sponsors with development and commercial incentives including market exclusivity, tax credits for clinical research costs and the waiver of certain administrative fees.

For more information on Spruce Biosciences and its lead clinical program for CAH, please visit sprucebiosciences.com.

About Spruce Biosciences
Spruce Biosciences is a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders. The Spruce team is leveraging their extensive expertise in endocrinology and orphan drug development to meet the significant unmet need of patients suffering from rare endocrine diseases. Spruce’s lead product candidate, SPR001, has a novel and clinically verified mechanism of action (MOA) and is currently in Phase 2 clinical trials for congenital adrenal hyperplasia, a rare disease that is screened in newborns and for which there is not yet an FDA-approved therapy. The Company is headquartered in San Francisco and closed a Series A Financing of $20 million in 2016. For more information on Spruce, please visit sprucebiosciences.com.

 

Media Contact
Amanda Guisbond
Canale Communications
781-405-8775
amanda@canalecomm.com


Spruce Biosciences Appoints Camilla V. Simpson to Board of Directors

Simpson brings 22 years of industry experience to Spruce, a clinical-stage biotech developing a novel treatment for congenital adrenal hyperplasia, a rare endocrine disease

San Francisco – November 13, 2017 – Spruce Biosciences, a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders, today announced that Camilla V. Simpson, Senior Vice President and Head of Product Portfolio Development at BioMarin Pharmaceutical Inc., has joined the Company’s board of directors.

“Having recently emerged from stealth mode to announce our Series A and Phase 2 clinical program for congenital adrenal hyperplasia (CAH), we are rapidly building out our operations and gearing up for an active 2018, from both a clinical and regulatory perspective. As such, I am very pleased to have Camilla join our board and be able to leverage her wealth of knowledge and experience in developing and registering specialty and rare disease products globally from her time at BioMarin Pharmaceutical Inc., Shire and Abbott Laboratories,” said Alexis Howerton, Ph.D., Chief Executive Officer of Spruce Biosciences.

Camilla V. Simpson is Senior Vice President and Head of Product Portfolio Development at BioMarin Pharmaceutical Inc. Ms. Simpson is responsible for the Product Development Strategy of BioMarin’s rare disease portfolio.

Previously, Ms. Simpson was Group Vice President of Regulatory Affairs at BioMarin, and has 22 years of experience in the industry. She holds a B.Sc. in Science from the National University of Ireland Galway, a B.Sc. Hons in Chemistry from Kingston University, UK and an M.Sc. with distinction in Analytical Chemistry from Birkbeck College, University of London, UK.

“I am delighted to join Spruce’s board during an exciting time in the company’s evolution,” said Simpson. “Over the course of my career, I have had the great pleasure of devising global product development and regulatory strategy for multiple rare disease therapies and am looking forward to leveraging my experience on behalf of Spruce as the company advances its lead program in CAH.”
For more information on Spruce Biosciences and its lead clinical program for CAH, which is currently enrolling patients in a Phase 2 trial, please visit sprucebiosciences.com.

About Spruce Biosciences

Spruce Biosciences is a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders. The Spruce team is leveraging their extensive expertise in endocrinology and orphan drug development to meet the significant unmet need of patients suffering from rare endocrine diseases. Spruce’s lead product candidate, SPR001, has a novel and clinically verified mechanism of action (MOA) and is currently in Phase 2 clinical trials for congenital adrenal hyperplasia, a rare disease that is screened in newborns and for which there is not yet an FDA-approved therapy. The Company is headquartered in San Francisco and closed a Series A Financing of $20 million in 2016. For more information on Spruce, please visit sprucebiosciences.com.

 

Media Contact
Amanda Guisbond
Canale Communications
781-405-8775
amanda@canalecomm.com


Spruce Biosciences is a clinical-stage biotechnology company developing novel therapies to better serve patients with rare endocrine disorders. Our team has extensive experience with managing patients with rare endocrine diseases as well as developing novel therapeutics to treat patients with unmet needs. As a team, we are committed to transforming the quality of life for patients who have been underserved by scientific innovation.