Novo Holdings and Sound Bioventures Launch Breye Therapeutics to Develop Novel Oral Therapies for Eye Diseases

  • Industry Specialist Ulrik Mouritzen MD. appointed general manager
  • Financing to bring the main asset to the phase 1b clinical trial and pipeline development

Copenhagen, Denmark, November 10, 2022 /PRNewswire/ — Breye Therapeutics ApS (Breye), a clinical-stage biopharmaceutical company developing novel oral therapies for retinal vascular disease in ophthalmology, today announces that it has come out of hiding after closing a seed funding for 4 million euros led by Novo Holdings and Sound Bioventures.

Diabetic retinopathy (DR) affects approximately 30% of all diabetic patients and is the leading cause of blindness in working-age adults. Age-related macular degeneration (AMD) affects approximately 25% of people over 60 and is the leading cause of blindness in older people. Breye offers two new and relevant oral therapies to treat both DR and AMD.

Breye is led by CEO, Ulrik Mouritzen, a physician and industry veteran with over 20 years of R&D, regulatory and commercial experience in Europe and the United States. He was previously at Zealand Pharma A/S where, as Vice President, Head of Clinical Development, he successfully led the advancement of three Phase 3 development programs, one of which is now FDA cleared. Proceeds from the financing will be used to advance Breye’s lead compound to phase 1b and advancing its second molecule towards studies enabling IND. In addition, the company will strengthen its scientific leadership team to further prepare its assets for later stages of clinical development and expand its pipeline to a broader range of ophthalmological diseases.

Ulrik MouritzenCEO of Breye Therapeutics, said: “Products currently marketed for patients with DR and AMD are based on needle injections delivered directly into the eyes and are burdensome to patients and caregivers with limited efficacy. Breye is focused on delivering real market breakthroughs by developing administered small molecule therapeutics, which can halt and reverse the underlying cause of disease I am delighted that Breye has the support of these leading life science investors as we are progressing towards the development of two distinct and therapeutically relevant molecules that have the potential to address a very large unmet medical need.”

Breye is part of Novo Seeds’ venture creation efforts where the Novo Holdings investment team works with peers across the Nordic region to help create new biotech companies based on groundbreaking new scientific and industrial discoveries.

Jørgen Søberg Petersen, Partner at Novo Seeds, added: “We are delighted to support Breye in his mission to develop safe orally administered medicines that can lead to better patient outcomes. Ulrik brings extensive clinical development and industry experience to the company. build a world-class team and deliver breakthrough new treatments for eye diseases.”

The combined market for DR and AMD exceeds 15 billion US dollars today and is expected to grow at a CAGR of 7% over the next few years. Sales of the current market-leading product for the treatment of late-stage DR and AMD have exceeded 8 billion US dollars in 2021.

Johan Kördel, Managing Partner at Sound Bioventures, commented: “There is a huge unmet need for therapies that can target key disease pathologies and enable earlier intervention to halt and reverse ongoing eye damage. Breye’s new risk-free approach is well positioned to address this sizeable market and alleviate the needs of patients and caregivers. This investment is part of our strategy of investing and supporting breakthrough clinical-stage innovation in Scandinavia.”

Alongside the financing, Jørgen Søberg Petersen, partner at Novo Holdings and Johan Kördel, managing partner at Sound Bioventures will join the board, alongside the independent chairman Jim Van heusden and CEO Ulrik Mouritzen. The pre-seed financial support provided to the company includes funding from the BioInnovation Institute (BII), the Danish Foundation for Growth (Vækstfonden) and the Danish Foundation for Innovation (Innovationsfonden).

Breye has in-licensed the rights to its lead treatment, danegaptide, from Zealand Pharma A/S. Danegaptide is an orally administered small molecule drug that has been shown to have an excellent documented safety profile in multiple clinical trials with over 500 human subjects. Under the direction of Ulrik MouritzenBreye has generated compelling preclinical proof-of-concept data in several diabetic eye disease models as part of its mission to develop orally available drug candidates for eye disease.

About Breye Therapeutics

Breye Therapeutics is a clinical-stage biopharmaceutical company headquartered in Denmark pursues a mission of developing new oral therapies for the treatment of retinal vascular diseases. The Company develops risk-free, safe and novel small molecules suitable for oral administration that have strong scientific justification for the treatment of diseases such as diabetic retinopathy (DR) and age-related macular degeneration (AMD). Breye has raised a funding round from Novo Holdings and Sound BioVentures and has received financial support from the BioInnovation Institute, the Danish Foundation for Growth (Vækstfonden) and the Danish Foundation for Innovation (Innovationsfonden). For more information, please visit: https://breyetx.com

About Novo Holdings A/S

Novo Holdings A/S is a private limited company wholly owned by the Novo Nordisk Foundation. It is the holding company of the Novo Group, consisting of Novo Nordisk A/S and Novozymes A/S, and is responsible for managing the assets of the Novo Nordisk Foundation.

Novo Holdings is recognized as a leading international life sciences investor focused on creating long-term value. As a life sciences investor, Novo Holdings provides seed and venture capital to early-stage companies and takes significant equity positions in growing and established companies. Novo Holdings also manages a large portfolio of diversified financial assets. Further information : www.novoholdings.dk.

About Sound Bioventures

Sound Bioventures is a venture capital fund that invests in clinical-stage or clinical-stage private companies in Europe and UNITED STATES developing therapies in specialized therapeutic areas. Sound Bioventures Fund I AB is a registered alternative investment fund under the Swedish Alternative Investment Fund Managers Act. www.soundbioventures.com

SOURCE Novo Holdings

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