Press Release

CAMBRIDGE, Mass., Sept. 05, 2019 (GLOBE NEWSWIRE) -- Scholar Rock Holding Corporation (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today announced the appointment of George G. Nomikos, M.D., Ph.D., as Vice President, Head of Medical Research, Muscle Franchise.  Dr. Nomikos is a physician-scientist with 35 years of academic and industry experience in neuroscience, neuropharmacology, and central nervous system therapeutics.  He has led a number of global drug development programs, ranging from preclinical studies to pivotal clinical trials and post-marketing requirements.  His clinical work contributed to the approval of an antidepressant, vortioxetine, and the acceptance of vortioxetine label updates in the U.S. and European Union.  At Scholar Rock, Dr. Nomikos will be the medical lead for the SRK-015 program in Spinal Muscular Atrophy (SMA) as well as future clinical programs in the muscle franchise.  

“We are thrilled to welcome George as we continue to expand the breadth of expertise to develop multiple product candidates for the treatment of a broad range of serious disorders,” said Yung Chyung, M.D., Chief Medical Officer of Scholar Rock.  “George’s extensive neurology drug development experience makes him an ideal medical lead to shape the SRK-015 program, particularly as we progress the Phase 2 TOPAZ trial in patients with SMA and further our relationships with researchers, physicians, and patient communities.”

“It is a privilege to apply my experiences both as a scientist and a physician to lead the SRK-015 development program during this pivotal time, with a number of clinical read-outs over the next couple of years,” said Dr. Nomikos.  “I look forward to working with the highly dedicated team at Scholar Rock to develop SRK-015 and other important therapies as we strive to meaningfully improve the lives of patients with unmet medical needs.”

Dr. Nomikos joins Scholar Rock from Biogen Inc., where he served as Senior Medical Director, Global Medical Lead for the BIIB054 clinical program for Parkinson’s disease.  Prior to Biogen, he was Senior Medical Director at Sage Therapeutics, leading the Phase 1 and 2 clinical trials for SAGE-217 in movement and mood disorders.  Before joining Sage, Dr. Nomikos held various senior scientific positons at Takeda Pharmaceuticals Company Ltd., Astellas Pharma, Inc., Amgen, Inc., and Eli Lilly and Company, amongst other companies.  Prior to the transition to industry, Dr. Nomikos was a Docent (Associate Professor) with teaching and research responsibilities at the Karolinska Institute in Stockholm. Dr. Nomikos received his M.D. from the University of Athens and a Ph.D. in Neuroscience from the Department of Psychiatry, University of British Columbia. 

About SRK-015
SRK-015 is a selective inhibitor of the activation of myostatin and is an investigational product candidate for the treatment of patients with spinal muscular atrophy (SMA).  Myostatin, a member of the TGF-beta superfamily of growth factors, is expressed primarily by skeletal muscle cells and the absence of its gene is associated with an increase in muscle mass and strength in multiple animal species.  Scholar Rock believes the inhibition of the activation of myostatin with SRK-015 may promote a clinically meaningful increase in muscle mass and strength.  A Phase 2 clinical trial in patients with Type 2 and Type 3 SMA is ongoing.  The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD), and the European Commission (EC) has granted Orphan Medicinal Product Designation, to SRK-015 for the treatment of SMA.  The effectiveness and safety of SRK-015 have not been established and SRK-015 has not been approved for any use by the FDA or any other regulatory agency.

About Scholar Rock
Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role.  Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, fibrosis and anemia.  Scholar Rock’s newly elucidated understanding of the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level.  By developing product candidates that act in the disease microenvironment, the Company intends to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect.  Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path. For more information, please visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/).

Scholar Rock® is a registered trademark of Scholar Rock, Inc.

Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the ability of new executives to influence Scholar Rock’s progress, Scholar Rock’s ability to develop its pipeline, and Scholar Rock’s growth expectations. The use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include those risks more fully discussed in the section entitled "Risk Factors" in Scholar Rock’s Annual Report on Form 10-Q for the quarter ended June 30, 2019, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock’s views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.

Scholar Rock Contact:
Investors/Media
Catherine Hu
chu@scholarrock.com
917-601-1649

Media Contact:
The Yates Network
Kathryn Morris
kathryn@theyatesnetwork.com
914-204-6412

Source: Scholar Rock