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Scholar Rock Holding Corporation (SRRK) is a biotechnology company dedicated to pioneering a novel class of biologic therapies known as 'niche modulators'. These therapies selectively target the activation of growth factors within the disease microenvironment, offering a groundbreaking approach to treating serious medical conditions. Scholar Rock's initial proprietary and partnered drug discovery programs focus on specific growth factors, particularly members of the TGF-beta superfamily, which are critical in regulating cell growth and differentiation. These growth factors are notably present in the microenvironments of significant diseases like fibrosis, musculoskeletal disorders, and autoimmune diseases.
The company’s innovative therapeutic strategy stems from the foundational scientific discoveries of its founders, Professors Timothy Springer, PhD, and Leonard Zon, MD, from Children's Hospital Boston and Harvard Medical School. These discoveries illuminate the molecular mechanisms of growth factor activation, empowering Scholar Rock to advance its ground-breaking treatments.
Scholar Rock is backed by a consortium of top-tier life sciences investors, including Polaris Partners and Arch Venture Partners. Its flagship product candidate, Apitegroma, is a selective, fully human, monoclonal antibody that inhibits the activation of the growth factor myostatin in skeletal muscle. This innovative mechanism holds promise for treating neuromuscular disorders. Another key product in the company's pipeline is SRK-181, which targets the activation of latent transforming growth factor beta-1 (TGFβ1) and is being developed to treat cancers that are resistant to existing anti-PD-(L)1 antibody therapies.
With its operations based in the United States, Scholar Rock continues to make significant strides in the biopharmaceutical industry, pushing the envelope of medical science and offering hope for effective treatments against some of the most challenging diseases.
Scholar Rock has initiated the pivotal Phase 3 SAPPHIRE clinical trial for apitegromab, targeting non-ambulatory patients with Type 2 and 3 spinal muscular atrophy (SMA). The company has advanced to Part B of the DRAGON Phase 1 study for SRK-181, which seeks to address checkpoint inhibitor resistance in various cancers. Following the conclusion of its partnership with Gilead, Scholar Rock regained rights to its preclinical assets. The company ended 2021 with approximately $253 million in cash and equivalents.
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company, will present at the 40th Annual J.P. Morgan Healthcare Conference on January 11, 2022, at 7:30 a.m. ET. The presentation can be accessed via a live webcast on their website, with an archived replay available for 90 days. Scholar Rock focuses on developing innovative treatments targeting serious diseases related to protein growth factors. Their proprietary platform aims to create monoclonal antibodies that selectively target these signaling proteins, addressing challenges in therapeutic development.
Scholar Rock has announced the design of the SAPPHIRE trial, a pivotal Phase 3 study for apitegromab, targeting non-ambulatory Type 2/3 spinal muscular atrophy (SMA). This randomized, double-blind trial aims to evaluate the drug's efficacy in approximately 156 patients aged 2-12, with results informed by positive insights from the prior TOPAZ trial. Patients will be treated for 12 months, with a primary endpoint assessing changes in the Hammersmith Functional Motor Scale (HFMSE). SAPPHIRE is set to commence across 55 global sites, addressing a significant unmet medical need in SMA treatment.
Scholar Rock (NASDAQ: SRRK) announced the initiation of Part B of the DRAGON Phase 1 trial for SRK-181, a TGFβ1 inhibitor, following supportive results from Part A. The trial aims to overcome resistance to anti-PD-(L)1 therapies in patients with advanced solid tumors. Initial data revealed no dose-limiting toxicities, and preliminary efficacy results showed stable disease in several patients. Part B will include multiple tumor cohorts, with early efficacy data expected in 2022.
Scholar Rock (NASDAQ: SRRK) reported Q3 2021 results, revealing a net loss of $37.5 million ($1.02 per share), up from a loss of $23.6 million ($0.79) a year earlier. Revenue reached $5.5 million, driven by a collaboration with Gilead. Key updates include the upcoming initiation of a Phase 3 trial for apitegromab in non-ambulatory Type 2 and 3 SMA patients and progress in the DRAGON trial for SRK-181. Additionally, a U.S. patent for SRK-181 extends protection to May 2040, enhancing its market position.
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on serious diseases, announced its participation in several upcoming investor conferences. On November 9, it will present at the Credit Suisse Virtual Healthcare Conference, followed by the Cowen IO Next Virtual Summit on November 15. The company will also attend the Jefferies Global Healthcare Conference in London on November 17 and the Piper Sandler Virtual Healthcare Conference from November 30 to December 2. Webcasts of the presentations will be available on the company's website.
Scholar Rock (NASDAQ: SRRK) has announced an e-poster presentation of clinical results from the TOPAZ Phase 2 trial of apitegromab for Type 2 and 3 spinal muscular atrophy (SMA) during the 25th World Congress of Neurology (WCN) from October 3-7, 2021. The presentation shows positive correlations between serum levels of latent myostatin and motor function improvements. Apitegromab is a selective myostatin inhibitor with FDA Fast Track, Orphan Drug, and Rare Pediatric Disease designations, but its efficacy and safety have yet to be established.
Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company, announces a late-breaking poster presentation at the 50th Child Neurology Society Annual Meeting held from September 29 to October 2, 2021, in Boston. The presentation focuses on the efficacy of Apitegromab in patients with later-onset Spinal Muscular Atrophy (SMA) Types 2 and 3, highlighting responder analyses from the Phase 2 TOPAZ study. The poster will be published in the 2021 Annals of Neurology supplement. Apitegromab has received multiple designations from the FDA and EMA, although its efficacy and safety are not yet established.
Scholar Rock (NASDAQ: SRRK) announced the issuance of U.S. Patent No. 11,130,803, expiring May 2040, for SRK-181, a selective TGFβ1 inhibitor aimed at treating patients resistant to checkpoint inhibitors like anti-PD-(L)1 therapies. This patent fortifies the company's intellectual property as it progresses in the DRAGON Phase 1 trial, which focuses on safety and effectiveness in various solid tumor types. Initial clinical data from the trial is expected by year-end, reinforcing Scholar Rock's commitment to developing innovative cancer treatments.
Scholar Rock (NASDAQ: SRRK) recently presented two posters at the World Muscle Society Virtual Congress from September 20-24, 2021. The presentations highlighted findings from the TOPAZ Phase 2 trial of apitegromab for treating Spinal Muscular Atrophy (SMA). Key results include improvements in various efficacy endpoints such as Hammersmith scales and Revised Upper Limb Module (RULM) scores among patients. This research supports the potential of apitegromab and sets the stage for a Phase 3 trial aimed at establishing it as a leading muscle-directed therapy for SMA by year-end 2021.
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