Press Releases

Munich, Germany, November 30, 2021
Isarna Therapeutics Announces First Patient Enrolled in International Phase 2a Clinical Study in Ophthalmology Indications Wet AMD and DME

Isarna Therapeutics today announced the enrollment of the first patient in the BETTER Study, a parallel, two-segment Phase 2a clinical study to evaluate Isarna’s lead candidate ISTH0036 in patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). The study aims to enroll as many as 24 patients for each indication and will be led by internationally renowned experts at clinical trial centers in Austria and India with lead investigators Prof. Matthias Bolz and Priv. Doz. Rupert Strauss at the Kepler University in Linz, Austria. The study’s objective is to evaluate ISTH0036 in these two indications and gain data that will enable the transition into a Phase2b/3 clinical trial.

“Based on the positive results from our Phase 1 study supporting the safety of ISTH0036 and the encouraging data from preclinical studies in retinal disease, Isarna has committed to exploring ISTH0036 in ophthalmic indications where TGF-β plays a vital role in disease progression and where we see the greatest potential value for patients,” said Prof. Marion Munk, CMO of Isarna Therapeutics.

The Phase 2a trial will gather data on the reduction of retinal fluid and central macular thickness (CMT) as the primary endpoint and improvement of visual acuity (VA) as a secondary endpoint during a treatment period of seven months, followed by a two-month safety follow-up. The trial aims to explore the prevention of fibrosis and epithelial-mesenchymal transition as a key differentiator to currently approved anti-angiogenic therapies, mostly targeting Vascular Endothelial Growth Factors (VEGF). Furthermore, the durability of the antisense therapy ISTH0036 will be evaluated, which showed target suppression in preclinical models for more than four months. Patients selected for the trials will include both newly diagnosed, treatment naïve patients and those who have already been treated with anti-VEGF therapeutics.

Wet AMD causes reduced vision in the center of the eye and affects as many as 190 million people globally1. Macular edema occurs when there is abnormal leakage and accumulation of fluid in the macula from damaged, dysfunctional blood vessels in the retina. A common cause of macular edema is diabetes, which is the leading cause of irreversible blindness in mature adults in the U.S.Both diseases can be treated with a range of anti-VEGF drugs however, these therapeutics are not able to maintain visual acuity as many patients develop fibrosis during the disease progression.

“Fibrosis is a primary concern in long-term retina pathologies and is a key driver of significant vision loss even under optimal gold-standard therapy with anti-VEGF. ISTH0036 could be the first drug that targets and prevents development of fibrosis and therefore may become a unique and promising new therapy for retinal indications,” said Dr. René Rückert, COO of Isarna Therapeutics. Isarna has developed ISTH0036 to target the transforming growth factor-beta (TGF-β), a protein which is chronically elevated in ophthalmic, fibrotic, immunologic, and cancerous diseases. ISTH0036 suppresses TGF-β protein production via well-studied antisense mechanisms.

ABOUT ISARNA

Isarna Therapeutics was built on profound knowledge in antisense oligonucleotide design and therapeutic development of this innovative compound class. Today, Isarna is developing a portfolio of antisense therapies targeting an emerging therapeutic field in human biology: TGF-β signaling. Precise modulation of TGF-β pathways using antisense therapy may result in safer and more effective treatment options for a broad range of indications. Currently, Isarna is focused on ophthalmology; its lead compound, ISTH0036, will soon enter Phase 2a clinical development in the blockbuster indications AMD and DME. In addition, Isarna has established a portfolio of antisense compounds addressing three important isoforms of TGF-β to treat fibrotic liver disease, such as NASH, and various forms of cancer.

 

Contact Isarna

Claus Schalper, CEO
info@isarna-therapeutics.com

 

Media Inquiries

Trophic Communications
Gretchen Schweitzer or Desmond James

Phone: +49 171 35 12 733
isarna@trophic.de

Please click below to download the Press Release


 

 

Munich, Germany, September 30, 2021
Isarna Therapeutics Appoints Claus Schalper as CEO

Isarna Therapeutics today announced the appointment of Claus Schalper as Chief Executive Officer. Mr. Schalper joins Isarna with over 20 years of experience as an executive and serial entrepreneur in the life science and biotech industries. His appointment expands Isarna’s management team, which includes Prof. Marion R. Munk as Chief Medical Officer, Dr. René Rückert as Chief Operating Officer and Chris Huiskamp as Chief Financial Officer. The leadership team will be focused on developing Isarna’s lead product ISTH0036 as a promising therapeutic candidate for diseases of the eye.

“Isarna has reached an exciting stage of development for its lead program, ISTH0036, which has broad applicability in a range of ophthalmology indications,” said Claus Schalper, CEO of Isarna Therapeutics. “I value the opportunity to work together with Marion, René and Chris as we move ISTH0036 toward the next clinical trial to further evaluate its potential to benefit patients with retinal diseases that continue to have a high level of unmet medical need.”

Claus Schalper, MBA, joins Isarna from Pieris Pharmaceuticals, a company that he co-founded in 2001 and where he held the position of Chief Financial Officer among other roles, playing an important part in the company’s evolution into a US-NASDAQ listed biotechnology company. Mr. Schalper also co-founded XL-protein GmbH and led the company to profitability by executing a series of collaborations with pharma and biotech companies. Mr. Schalper began his career with Arthur Andersen and subsequently served as CEO for several companies in the technology industry. He holds a Master of Business Administration from the University of Bamberg, Germany.

“Claus brings a broad range of leadership and corporate development experience to Isarna. With the management team now in place, the company is well-positioned to implement its product development strategy and reach the next value inflection points for ISTH0036 in ophthalmology,” said Matthias Kromayer, Managing Partner and member of the Executive Board at MIG Capital, Isarna’s lead investor

Prof. Marion R. Munk, MD, PhD, FEBO, joined Isarna as Chief Medical Officer in 2019. She brings over 10 years of clinical expertise in retina, uveitis and age-related macular degeneration research and is a board-certified ophthalmologist currently serving as attending retina specialist and Managing Director of the Bern Photographic Reading Center at the University Hospital Bern, Switzerland. She previously worked at the Feinberg School of Medicine, Chicago, Illinois and the AKH Vienna, Austria, and serves as a consultant for many key players in the ophthalmology drug and device development space. Prof. Munk holds a bachelor’s degree in theoretical physics as well as a MD and PhD in ophthalmology and clinical neuroscience from the Medical University, Vienna.

René Rückert, MD, MBA, joined Isarna in 2018 as interim CMO and in 2019 took the role of the Chief Operating Officer. He brings extensive experience in ophthalmology drug development including many years as a leader and global manager at Bayer and Novartis where he led the global development of the current gold standard therapies in AMD and DME, Eylea and Lucentis. Dr. Rückert previously served as Clinical Vice President, Chief Medical Officer and Chief Operating Officer at a number of innovative biotech and Medtech Companies. In his role at Isarna, Dr. Rückert oversees the company’s operations and clinical development programs and supports the company with his business acumen and his global network. Dr. Rückert is a trained immunologist and board-certified for biochemistry; he received his medical degree from the Charité Berlin, Germany and an MBA from the Warwick Business School, UK.

Isarna Therapeutics has extensive expertise in antisense therapies targeting the messenger RNA (mRNA) transcript for transforming growth factor (TGF)-β, a protein that is chronically elevated in ophthalmic and fibrotic diseases and is used as escape mechanisms by tumors during immune therapy. In ophthalmic indications, fibrosis is a key driver of reduced vision and lack of long-term efficacy of current therapies, TGF-β is a key driver of fibrosis, so ISTH0036 could be the first therapy to prevent the fibrotic changes in patients with retinal pathologies. The company’s Phase 2 candidate, ISTH0036, blocks TGF-β 2, which is a major driver of severe retinal diseases such as, wet (neovascular) age-related macular degeneration (AMD) and diabetic macular edema (DME). Preclinical evidence supports a key role of TGF-β 2 in macular edema and neovascularization, supporting the development in AMD and DME as an intravitreal injection. Animal data support target engagement and therefore suppression of TGF-β 2 beyond four months after a single intravitreal injection. The company previously presented data from its Phase 1 dose-escalation trial with ISTH0036 in which the compound showed excellent safety and was well-tolerated at all dose levels.

ABOUT ISARNA

Isarna Therapeutics was built on profound knowledge in antisense oligonucleotide design and therapeutic development of this innovative compound class. Today, Isarna is developing a portfolio of antisense therapies targeting an emerging therapeutic field in human biology: TGF-β signaling. Precise modulation of TGF-β pathways using antisense therapy may result in safer and more effective treatment options for a broad range of indications. Currently, Isarna is focused on ophthalmology; its lead compound, ISTH0036, will soon enter Phase 2a clinical development in the blockbuster indications AMD and DME. In addition, Isarna has established a portfolio of antisense compounds addressing three important isoforms of TGF-β to treat fibrotic liver disease, such as NASH, and various forms of cancer.

 

Contact Isarna

info@isarna-therapeutics.com

 

Media Inquiries

Trophic Communications
Gretchen Schweitzer or Desmond James

Phone: +49 171 35 12 733
isarna@trophic.de

Please click below to download the Press Release