Spruce Biosciences Closes on $88 Million Series B Round, Advancing CAH Program

Funding

Spruce Biosciences, based in San Francisco, closed on a Series B financing round worth $88 million. The round was co-led by Omega Funds and Abingworth and supported by existing investors Novo Holdings and RiverVest Venture Partners. New investors included HealthCap Partners, Rock Springs Capital, Surveyor Capital (a Citadel company), Aisling Capital and Sands Capital.

In September 2019, the company announced positive results from a Phase IIa, multicenter, 12-week clinical trial of tildacerfont for congenital adrenal hyperplasia (CAH). CAH is a rare genetic disorder that affects the ability of the adrenal glands to work appropriately. It is caused by a mutation in the gene that encodes for the enzyme 12-hydroxylase. As a result, people with CAH do not produce the hormone cortisol effectively, which can result in life-threatening adrenal crises.

“There is a significant and urgent need for new CAH treatments as there are currently no FDA-approved therapies,” said Richard Auchus, an investigator in the trial and professor of internal medicine and pharmacology, division of metabolism, endocrinology & diabetes at the University of Michigan, Ann Arbor, at the time. “The results of this study are encouraging as they demonstrate, for the first time, that a novel non-steroidal treatment can produce clinically meaningful reductions across key biomarkers over a period of 12 weeks. These data indicate tildacerfont could be a promising new treatment option for patients with CAH.”

Spruce intends to use the funds raised to evaluate tildacerfont to reduce glucocorticoid (GC) steroid usage in adults with CAH, and to complete proof-of-concept trials in children.

Tildacerfont is a second generation CRF-1 receptor antagonist.

“We are impressed with the potential for tildacerfont to become the first approved treatment for patients with classic congenital adrenal hyperplasia around the world, as well as the encouraging positive results recently announced from its Phase II clinical trial,” said Dina Chaya, Advisor to Mega Funds. “This drug could be a life-altering therapy for patients with CAH.”

Wiebke Arit, director of the Institute of Metabolism and Systems Research at the University of Birmingham, UK, noted, “Existing treatment for CAH is limited to chronic glucocorticoid replacement, and is often unsatisfactory, resulting in many patients continuing to suffer from excess androgen production and high GC exposure. In addition to addressing these unmet needs in CAH, tildacerfont’s mechanism of action could also be relevant in patients suffering other abnormalities of the hypothalamic-pituitary adrenal axis, including non-classic CAH, Cushing’s Disease, and polycystic ovary syndrome.”

Prior to this Series A round, the company had raised $20 million in a Series A round in January 2016.

“The potential utility of tildacerfont, as well as an interest in broader rare endocrine disorders, has attracted a strong group of investors,” said Richard King, president and chief executive officer of Spruce Biosciences. “We are thrilled to partner with these highly respected investors, who have a track record in backing the most promising science and a history of successful biopharmaceutical company development. I look forward to leading our highly experienced management team as we advance the development of tildacerfont in CAH and other indications for the benefit of this underserved patient population.”

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