Novo Holdings and Sound Bioventures launch Breye Therapeutics to develop novel oral therapies for ophthalmologic diseases

•     Industry expert Ulrik Mouritzen M.D. appointed Chief Executive Officer

•     Funding to advance lead asset to phase 1b clinical trial and further build pipeline

Copenhagen, Denmark, 10 November 2022 – Breye Therapeutics ApS (Breye), a clinical-stage biopharmaceutical company developing novel oral therapies for retinal vascular diseases within ophthalmology, today announces it has emerged from stealth after closing a seed financing of EUR 4 million led by Novo Holdings and Sound Bioventures.

Diabetic retinopathy (DR) affects approximately 30% of all patients with diabetes and is the leading cause of blindness among working-age adults. Age-related macular degeneration (AMD) affects approximately 25% of people older than 60 years of age and is the leading cause of blindness within the elderly population. Breye has two novel and relevant oral therapies to address both DR and AMD.

Breye is led by Chief Executive Officer, Ulrik Mouritzen, an M.D. and industry veteran with more than 20 years of R&D, regulatory and commercial experience in Europe and the US. He was previously at Zealand Pharma A/S where, as Vice President, Head of Clinical Development, he led the successful advancement of three programs into phase 3 development of which one product is now FDA approved. Proceeds from the financing will be used to advance Breye’s lead compound to phase 1b and advance its second molecule towards IND-enabling studies. Additionally, the Company will add to its Scientific Leadership Team to further prepare its assets for later stages of clinical development and expand its pipeline across a broader range of ophthalmologic diseases.

Ulrik Mouritzen, Chief Executive Officer of Breye Therapeutics, said: “The currently marketed products for patients with DR and AMD are based on needle injections administered directly into the eyes and are burdensome for patients and caregivers with limited efficacy. Breye is focused on bringing real breakthroughs to the market by developing first-in-class orally administered small molecule therapeutics, which can halt and reverse the underlying cause of the disease. I am delighted that Breye has the support of these top-tier life science investors as we make progress towards developing two distinct and therapeutically relevant molecules which have the potential to address a very large unmet medical need.”

Breye is part of Novo Seeds’ company creation efforts where the Novo Holdings’ early-stage investment team works with peers in the Nordic region to help build new biotech companies based on groundbreaking new science and industry spinouts.

Jørgen Søberg Petersen, Partner at Novo Seeds, added: “We’re pleased to back Breye in its mission to develop orally administered, safe medicines that can lead to better patient outcomes. Ulrik brings a wealth of clinical development and industry experience to the Company. We look forward to supporting him in his efforts to build a world-class team and bring about new, paradigm-shifting treatments for ophthalmologic diseases.”

The combined market for DR and AMD exceeds US$15 billion today and is expected to grow at a CAGR of 7% over the next several years. The sales for the current market-leading product for treating late-stage DR and AMD manifestations exceeded US$8 billion in 2021.

Johan Kördel, Managing Partner at Sound Bioventures, commented: “There is immense unmet need for therapies that can target the core disease pathologies and allow earlier intervention to halt and reverse the ongoing damage to the eyes. Breye’s novel, de-risked approach is well positioned to address this considerable market and alleviate the needs of patients and caregivers. This investment is aligned with our strategy of investing and supporting ground-breaking clinical stage innovation in Scandinavia.”

In conjunction with the financing Jørgen Søberg Petersen, Partner at Novo Holdings and Johan Kördel, Managing Partner at Sound Bioventures will join the Board of Directors, alongside independent Chair Jim Van heusden and CEO Ulrik Mouritzen. Pre-seed financial support provided to the Company includes funding from the BioInnovation Institute (BII), the Danish Growth Foundation (Vækstfonden) and the Danish Innovation Foundation (Innovationsfonden).

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