SGK

Oculis kicked off the year on a positive note with a mid-stage success in a rare ophthalmic condition, setting the stage for clinical development in the US. The Swiss drugmaker’s serum glucocorticoid kinase-2 activator OCS-05 met the primary endpoint in the Phase 2 ACUITY trial in 36 patients in France with acute optic neuritis who were taking steroids, according to a Monday release . There was no difference between the two treatment arms in the percentage of subjects with abnormal electrocardiogram parameters, the company said. Oculis also said the 3 mg/kg dose of the drug was effective, producing a statistically significant 18-letter improvement in low contrast letter acuity compared with placebo at three months. Treated patients also saw a 43% improvement in ganglion cell-inner plexiform layer thickness versus placebo and a 28% improvement in retinal nerve fiber layer thickness. Mark Kupersmith, vice chair of translational research at Icahn School of Medicine, said in the release that if the Phase 2 data are replicated in larger studies, they could have “profound implications, not only for this condition, but potentially for [multiple sclerosis] and other optic nerve disorders as well as glaucoma.” In November, Stifel analysts wrote that each of Oculis’ programs have blockbuster potential. The FDA has cleared Oculis’ IND application for OCS-05, allowing the start of clinical development in the US. The biotech currently has around $105 million to $110 million in cash, equivalents and short-term investments to help fund this work. While the company plans to stick with an IV formulation of OCS-05 for further development in acute optic neuritis, it is also working on a topical version of the drug for neurotrophic keratitis which is expected to enter IND-enabling studies this year. “We are thinking about other, I would say, more friendly formulations for chronic diseases such as [intravitreal] and subcutaneous,” CEO Riad Sherif told analysts and investors on a Monday call. The Phase 2 success is a welcome change for the Zug-based drugmaker, which faced a series of setbacks in 2024. In June, Oculis’ candidate for dry eye disease missed statistical significance in a mid-stage test. Two months later, the company was forced to pull the plug on a second Phase 3 trial for its lead eye drop program for inflammation and pain following ocular surgery due to an undisclosed “third-party administrative error.” But Oculis said at the time that it plans to go ahead with an FDA filing based on data from a previous late-stage trial and a Phase 2 study. Editor’s note: This article was updated to add comments from a company call.

MONTREAL, Dec. 18, 2024 /PRNewswire/ - Thryv Therapeutics Inc., a clinical-stage biotechnology company pioneering novel therapies for cardiovascular diseases, is pleased to announce its attendance at the 43rd Annual J.P. Morgan Healthcare Conference, taking place January 13-16, 2025, in San Francisco, CA. The J.P. Morgan Healthcare Conference is the industry's leading global investment forum, bringing together top executives, investors, and innovators across the healthcare ecosystem. With over 500 healthcare companies presenting, the event showcases groundbreaking advancements in biotechnology, pharmaceuticals, and healthcare technologies. To arrange a meeting with Thryv Therapeutics during the conference, please contact us at [email protected]. About Thryv Therapeutics Thryv Therapeutics Inc. is a privately owned company based in Montreal, Quebec, Canada, pioneering a precision medicine approach to treating heart failure, atrial fibrillation, Long QT Syndrome and other cardiometabolic and cardiorenal diseases with potent and highly selective serum glucocorticoid inducible kinase 1 (SGK1) inhibitors. Numerous animal models have demonstrated that activation of SGK1 leads to inappropriate electrical and structural remodeling of the heart contributing to adverse outcomes in heart failure, atrial fibrillation, and genetic channelopathies, such as Long QT Syndrome. For more information, please visit . SOURCE Thryv Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

MONTREAL, Nov. 20, 2024 /PRNewswire/ - Thryv Therapeutics Inc., a clinical-stage biotechnology company pioneering novel therapies for cardiovascular diseases, is pleased to announce the appointment of Amy Sehnert, MD, as Chief Medical Officer (CMO). Dr. Sehnert will lead the clinical development and strategy for Thryv Therapeutics' expanding cardiometabolic product portfolio targeting serum glucocorticoid inducible kinase 1 (SGK1) – a kinase implicated in adverse electrical and structural remodeling of the heart. Dr. Sehnert is a pediatric cardiologist with 20 years of experience as a serial and founding medical lead at innovative biotech companies introducing precision diagnostics and therapeutics to the clinic. Dr. Sehnert joins Thryv Therapeutics from Bristol Myers Squibb (BMS), where she held leadership roles of increasing responsibility and most recently served as Vice President and Global Program Lead for cardiovascular assets transitioning from early to late development. Prior to her time at BMS, Dr. Sehnert served as Vice President, Clinical Science at MyoKardia, Inc., where she played a pivotal role in the development and approval of Camzyos® - a groundbreaking treatment for hypertrophic cardiomyopathy (HCM) - contributing to the $14 billion acquisition of MyoKardia by BMS in 2020. "I am thrilled to join Thryv Therapeutics at such an important time in the company's journey," said Dr. Sehnert. "Thryv Therapeutics' cutting-edge approach to cardiovascular diseases aligns with my passion for advancing precision medicine, and I look forward to working with the team to deliver transformative therapies to patients worldwide." Dr. Sehnert has also made notable contributions in other fields of medicine, such as maternal-fetal health, oncology, and genomics, leading early efforts in non-invasive prenatal testing (NIPT) and cell-free DNA applications now in wide clinical use. She holds a Doctor of Medicine degree from the University of Minnesota, completed Pediatrics Residency at University of Colorado, and Fellowship in Pediatric Cardiology at UCSF followed by faculty appointments at UCSF and Stanford University. In 2022 she was recognized as one of the Most Influential Women in Business by the San Francisco Business Times and among the Top 25 Healthcare Technology Leaders of San Francisco. She has co-authored over 60 peer-reviewed publications and has been involved in numerous international collaborations, making her an internationally recognized expert in her field. "On behalf of Thryv Therapeutics, I am excited to welcome Amy to the team," said Paul F. Truex, CEO of Thryv Therapeutics. "Dr. Sehnert brings a wealth of medical and clinical development knowledge in the field of cardiometabolic and genetic diseases. Her extensive experience in designing and executing late-stage clinical trials for genetic and broader cardiovascular diseases and leadership qualities will be invaluable as we enter the next phase of clinical development of our SGK1 portfolio." Dr. Philip Sager, Thryv Therapeutics' founding Chief Medical Officer, will continue to provide strategic clinical and regulatory guidance as the company's portfolio advances into later stage clinical studies. "Philip and his collaborators originally developed unique insights into the clinical potential for SGK1 in various cardiometabolic diseases and in particular, Long QT Syndrome. His tireless leadership and relentless passion for exploring these initial ideas advanced Thryv Therapeutics' portfolio to its current stage," said Paul F. Truex. "We're thankful for his continued, on-going contributions in his new role to all of our clinical programs and we are inspired by his commitment to finding treatments for these patient communities." About Thryv Therapeutics Thryv Therapeutics Inc. is a privately owned company based in Montreal, Quebec, Canada. Thryv Therapeutics is pioneering a precision medicine approach to develop potent and highly selective serum glucocorticoid inducible kinase 1 (SGK1) inhibitors to treat heart failure, atrial fibrillation, Long QT Syndrome and other cardiometabolic and cardiorenal diseases. Numerous animal models have demonstrated that activation of SGK1 leads to inappropriate electrical and structural remodeling of the heart contributing to adverse outcomes in heart failure, atrial fibrillation, and genetic channelopathies, such as Long QT Syndrome. For more information, please visit . SOURCE Thryv Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED