CA-SPRUCE-BIOSCIENCES
Spruce Biosciences, Inc. (Nasdaq: SPRB) (“Spruce”), a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for endocrine and neurological disorders with significant unmet medical need, and HMNC Brain Health GmbH (“HMNC”), a global precision psychiatry biopharma company, announced today a strategic collaboration to develop Spruce’s investigational product candidate, tildacerfont, a second-generation CRF1 receptor antagonist, with HMNC’s companion diagnostic, the proprietary Cortibon Genetic Selection Tool (“Cortibon”), for the treatment of MDD.
“We believe that Cortibon has the potential to enable tildacerfont to be advanced as a precision therapeutic for personalized medicine in patients with MDD,” said Javier Szwarcberg, M.D., M.P.H., Chief Executive Officer, Spruce Biosciences. “Hyperactive corticotropin-releasing factor (CRF) neurotransmission and CRF1 receptor signal transduction are critical mechanisms for stress pathophysiology that may lead to major depression. Tildacerfont may mediate responses to stress, which has the potential to address up to 50% of the MDD patients worldwide using Cortibon. We are excited to collaborate with HMNC and initiate a Phase 2 proof-of-concept study of tildacerfont and Cortibon for the treatment of MDD later this year.”
“Treatment of MDD is hampered by patient heterogeneity, meaning many patients will fail to respond adequately to currently used therapies. HMNC’s collaboration with Spruce marks a significant step forward in our mission to bring innovative treatments to patients with depression. Combining our companion diagnostic with Spruce’s promising therapeutic offers a new avenue for precision psychiatry,” said Dr. Maximilian Doebler, Chief Business Officer, HMNC. “Traditional treatments often fall short, trapping patients in a costly trial-and-error cycle. Our platform uses genetic markers to predict responses to psychiatric medications, potentially enhancing treatment efficacy and reducing costs. This collaboration represents a new era in mental health management.”
Under the agreement, HMNC will fund and conduct a Phase 2 proof-of-concept study of tildacerfont in MDD patients, who will be screened using Cortibon. Spruce has an option to in-license exclusive worldwide rights to Cortibon after completion of the study, if results are positive. If Spruce exercises its option, it will be responsible for the future worldwide development and commercialization of tildacerfont and Cortibon for the treatment of MDD under a collaboration framework that leverages HMNC’s ongoing expertise in precision psychiatry and companion diagnostics. Pursuant to the license terms, HMNC would be entitled to receive certain milestone payments and tiered royalties on net sales of tildacerfont in MDD.
About Tildacerfont
Tildacerfont is a potent and highly selective, non-steroidal, oral antagonist of the CRF1 receptor, which is the receptor for corticotropin-releasing factor (CRF), a hormone that is secreted by the hypothalamus. The CRF1 receptor is abundantly expressed in the brain and pituitary gland, where it is the primary regulator of the hypothalamic–pituitary-adrenal (HPA) axis. By blocking the CRF1 receptor, tildacerfont has the potential to address hyperactive brain CRF neurotransmission and aberrant functioning of the HPA axis in patients with major depressive disorder (MDD). No drug-related serious adverse events have been reported related to tildacerfont treatment in completed studies.
About Cortibon
Cortibon is HMNC’s proprietary companion diagnostic, representing a potentially groundbreaking approach in the treatment of major depressive disorder (MDD). By utilizing genetic markers, Cortibon aims to identify MDD patients who are more likely to respond to CRF1 receptor antagonism, thereby enhancing treatment outcomes and reducing the trial-and-error period typical in depression treatment. Traditional treatments often lead to long onset times and insufficient response rates, trapping patients in a costly and prolonged trial-and-error cycle. Cortibon may dramatically shift this paradigm by improving treatment efficacy and reducing both costs and time.
About Spruce Biosciences
Spruce Biosciences is a late-stage biopharmaceutical company focused on developing and commercializing novel therapies for endocrine and neurological disorders with significant unmet medical need. Spruce is developing its product candidate, tildacerfont, an oral, second-generation CRF1 receptor antagonist, for the treatment of congenital adrenal hyperplasia (CAH), polycystic ovary syndrome (PCOS) and major depressive disorder (MDD). To learn more, visit www.sprucebio.com and follow us on X @Spruce_Bio, LinkedIn, Facebook and YouTube.
About HMNC Brain Health
HMNC Brain Health (HMNC Holding GmbH) is a global precision psychiatry biopharma company headquartered in Munich, Germany, which is pioneering the development of personalized therapies powered by predictive companion diagnostics, leading to higher remission rates in populations identified by companion diagnostics. The company develops unique pipelines for targeting both major depressive disorder (MDD) and treatment-resistant depression (TRD) and has three depression development programs in Phase 2. The company has presence in both Germany and the U.S. and is backed by a renowned global VC, several family officers, and a strategic healthcare investor. More information at www.hmnc-brainhealth.com.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the design, results, conduct, progress and timing of Spruce’s clinical trials; Spruce’s expectations regarding the initiation of the Phase 2 POC study of tildacerfont and Cortibon in patients with MDD in the fourth quarter of 2024; the potential for Cortibon to enable tildacerfont to be advanced as a precision therapeutics for MDD and other disorders; tildacerfont’s potential to mediate stress responses and Spruce’s product candidate, strategy and regulatory matters. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as “anticipate”, “may,” “will”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Spruce’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with Spruce’s business in general, the impact of geopolitical and macroeconomic events, and the other risks described in Spruce’s filings with the U.S. Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Spruce undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240604004940/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Sai Life Sciences Opens Dedicated Facility for Veterinary APIs in Bidar, India18.9.2025 18:22:00 CEST | Press release
Sai Life Sciences (BSE: 544306 | NSE: SAILIFE), an innovator-focused Contract Research, Development, and Manufacturing Organization (CRDMO), today announced the opening of Unit VI, a dedicated facility for Veterinary Active Pharmaceutical Ingredient (API) production, in Bidar, India. Located alongside Unit IV, the company’s flagship API manufacturing site, Unit VI has been established exclusively for veterinary APIs. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250918612071/en/ Sai Life Sciences’ Veterinary APIs Unit in Bidar, India. The new facility is designed to meet the highest standards of safety, sustainability, and regulatory compliance, ensuring the production of high-quality APIs for veterinary applications. With this expansion, Sai Life Sciences aims to provide efficient and scalable manufacturing solutions to leading global animal health companies. Making the announcement, Krishna Kanumuri, CEO & Managing Direct
Celltrion Announces Commercial Availability of Omlyclo™ Across Europe at EADV 202518.9.2025 17:45:00 CEST | Press release
Celltrion’s Omlyclo™, the first and only omalizumab biosimilar in Europe, will be commercially available starting in Norway, with subsequent rollouts in European countries Results from the global Phase III clinical trial of Omlyclo™ (CT-P39) for the treatment of chronic spontaneous urticaria (CSU), allergic asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) will be presented at a satellite symposium during the 2025 European Academy of Dermatology and Venereology (EADV) Congress Celltrion highlights the strength of its expanding dermatology portfolio with positive clinical results for CT-P55, a biosimilar candidate referencing secukinumab With the launch of Omlyclo™, Celltrion underscores its commitment to advancing innovative and accessible treatments in immunology and dermatology Celltrion, Inc. today showcased its longstanding commitment to expanding its biosimilar portfolio in the field of immuno-dermatology by attending the 2025 European Academy of Dermatology and Venereo
Andersen Consulting tilføjer samarbejdsfirmaet Charter18.9.2025 17:14:00 CEST | Pressemeddelelse
Andersen Consulting udvider sine digitale transformationskapaciteter gennem en samarbejdsaftale med Charter, et canadisk konsulentfirma, der er specialiseret i IT-strategi, managed services og applikationslevering. Charter blev grundlagt i 1997 og leverer teknologiprojekter med en forretningsorienteret tankegang og dyb teknisk ekspertise, herunder inden for IT-rådgivning, cloud-infrastruktur, cybersikkerhed, applikationsudvikling, projektlevering og forretningsarkitektur. Charter hjælper traditionelle virksomheder, offentlige institutioner, tjenesteudbydere og mellemstore kunder med implementering, netværksinfrastruktur og kundeorienterede applikationer – der leveres gennem en livscyklus-tilgang fra strategi til udførelse. "Vores mål hos Charter har altid været at fjerne kompleksiteten fra IT og hjælpe organisationer med at bevæge sig fremad med tillid," siger Kelly Michell, præsident for Charter. "Vores samarbejde med Andersen Consulting gør det muligt for os at bringe vores integrere
Andersen Consulting udvider sit udbud inden for cybersikkerhed og teknologi med tilføjelsen af Move18.9.2025 17:06:00 CEST | Pressemeddelelse
Andersen Consulting har indgået en samarbejdsaftale med Move, der er en førende virksomhed inden for it-infrastruktur, driftstjenester og digitale løsninger til virksomheder. Move befinder sig i Norge og Sverige. Move blev grundlagt i 1989 og leverer konsulentydelser, it-løsninger og driftstjenester. Virksomheden har ekspertise inden for cybersikkerhed, cloud-løsninger, server- og lagringsløsninger, netværkskommunikation og implementering af AI. Move samarbejder med mellemstore og store virksomheder om at designe, implementere og drive sikre, skalerbare og fremtidssikrede it-miljøer. "Dette samarbejde er en spændende mulighed for at skabe endnu større værdi for vores kunder," siger Roald Sannæs, der er administrerende direktør i Move. "Med vores kompetencer og Andersen Consultings globale rækkevidde og ekspertise kan vi levere mere helhedsorienterede løsninger, der hjælper organisationer med at løse nutidens udfordringer og forudse fremtidens muligheder." "Move har opbygget et godt ren
Setting the Standard: AMRA Medical Recognized as one of TIME Magazine’s ‘World’s Top HealthTech Companies’18.9.2025 16:40:00 CEST | Press release
The inaugural ranking by TIME, in partnership with Statista, features AMRA as one of the world’s leading health technology companies that are “driving innovation, enhancing accessibility, and contributing to a more effective and sustainable health care system” AMRA Medical is proud to share its inclusion in the World’s Top HealthTech Companies list, published today by TIME in collaboration with Statista. This recognition positions AMRA among an elite group of global innovators that are leading healthcare transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250918372780/en/ AMRA Medical Recognized as one of TIME Magazine’s ‘World’s Top HealthTech Companies’ The selection, which comes just one week after celebrating AMRA’s 15 years of progress and innovation within the body composition space, highlights AMRA’s long-standing commitment to becoming a global leader in health informatics. By delivering detailed, reproduc
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom