Spruce Biosciences Raises $53.6 Million Private Placement Financing

Rare Daily Staff

Spruce Biosciences said it has raised $53.6 million in a private placement to advance its pipeline of experimental therapies for rare endocrine disorders.

The private placement includes participation from new and existing investors, including 5am Ventures, Abingworth, Armistice Capital, HealthCap, Novo Holdings A/S, RiverVest Venture Partners, and Rock Springs Capital.

“This financing is expected to allow us to fund operating and capital expenditures into the first half of 2025, including the completion of CAHmelia-203, with topline results anticipated in the second half of 2023, and topline results for CAHmelia-204 anticipated in the second half of 2024,” said Javier Szwarcberg, CEO of Spruce Biosciences.

Spruce’s lead product candidate, tildacerfont, is being developed as the potential first non-steroidal therapy for patients suffering from classic congenital adrenal hyperplasia (CAH). Spruce is also developing tildacerfont for women suffering from a rare form of polycystic ovary syndrome with primary adrenal androgen excess.

Classic congenital adrenal hyperplasia (CAH) is a rare genetic disorder that affects the proper functioning of the adrenal glands. CAH results from a mutation in the gene that encodes the enzyme 21-hydroxylase, which is necessary for the synthesis of key adrenal hormones. As a result, people with CAH have an impaired ability to produce the hormone cortisol, which can result in life-threatening adrenal crises. Cortisol is also known as “the stress hormone,” and is critical for the body’s response to stress, illness and injury. In CAH, the adrenal glands also often produce excessive levels of male sex hormones or androgens. While both sexes need androgens for proper growth and development, an excess can cause problems that may include precocious puberty, short stature, hirsutism, increased risk of testicular adrenal rest tumors in men, and virilization and menstrual dysfunction in women.

While CAH testing is part of the newborn screening program, treatment options are limited. Glucocorticoids are commonly used to treat CAH but are associated with a wide range of side effects, including weight gain, stunted growth in children, reduced bone mineral density, metabolic abnormalities and increased cardiovascular risk. No new treatment options for CAH have been approved for the past several decades.

Spruce’s tildacerfont is a second generation CRF-1 receptor antagonist and the first non-steroidal molecule to demonstrate an ability to normalize elevated androgens in patients with CAH in clinical studies. CAHmelia-203 is a randomized, double-blind, placebo-controlled, dose-ranging study evaluating the safety and efficacy of tildacerfont in adult patients with classic CAH and is designed to enroll approximately 72 patients with high levels of androstenedione while on their current glucocorticoid regimen.

Enrollment in the clinical trial is approaching 50 percent and topline results are anticipated in the second half of 2023. CAHmelia-204 is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of tildacerfont in adult patients with classic CAH. The study is designed to enroll approximately 90 patients on supraphysiologic doses of glucocorticoids at or above 30 mg/d hydrocortisone equivalent with normal or near normal levels of A4. Enrollment in the clinical trial recently surpassed 25 percent with topline results anticipated in the second half of 2024.

Photo: Javier Szwarcberg, CEO of Spruce Biosciences