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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 (NASDAQ: SRRK) announced a presentation of its DRAGON Phase 1 trial for SRK-181 at the 2021 ASCO Annual Meeting, focusing on patients with solid tumors resistant to checkpoint inhibitors. The trial aims to assess the efficacy of SRK-181, a selective TGFβ1 inhibitor, in overcoming this resistance. The poster will detail the trial design and biomarker analysis. The presentation is scheduled for June 4, 2021, showcasing SRK-181's potential to enhance tumor response when combined with anti-PD-(L)1 therapy.
Scholar Rock (NASDAQ: SRRK) announced its Q1 2021 financial results and progress on pipeline programs. Revenue decreased to $4.7 million from $5.0 million year-over-year, while net loss increased to $27.7 million, or $0.76 per share. The company highlighted positive top-line data from the TOPAZ Phase 2 trial for apitegromab, showing significant motor function improvements in SMA patients. Scholar Rock plans to initiate a Phase 3 trial by year-end 2021. With $315 million in cash, the company is well-positioned to fund operations into 2023.
Scholar Rock (NASDAQ: SRRK) announced the publication of Phase 1 trial results for apitegromab in the journal Advances in Therapy. Apitegromab, a selective myostatin inhibitor, aims to treat spinal muscular atrophy (SMA). Key findings include safety at doses up to 30 mg/kg and a 24-31 day half-life. Following positive Phase 2 results indicating improved motor function in Type 2 and Type 3 SMA, a Phase 3 trial is expected to start by the end of 2021. The FDA has granted Orphan Drug Designation and Rare Pediatric Disease designation for apitegromab.
Scholar Rock (NASDAQ: SRRK) announced the issuance of U.S. Patent No. 10,981,981, expiring in May 2034, covering methods for inhibiting myostatin activation. This patent supports the company’s proprietary platform that targets precursor growth factors. CEO Tony Kingsley highlighted the recent positive results from the TOPAZ Phase 2 trial for apitegromab, which aims to enhance motor function in spinal muscular atrophy (SMA) patients. The trial demonstrated significant potential for apitegromab as a first muscle-directed therapy for SMA.
Scholar Rock (NASDAQ:SRRK) announced a poster presentation at the AACR Annual Meeting 2021, detailing biomarker assays for its DRAGON Phase 1 trial of SRK-181, a selective TGFβ1 inhibitor. This investigational candidate targets patients with advanced solid tumors resistant to checkpoint inhibitors. The e-poster, titled “Development of a Comprehensive Biomarker Strategy to Support the Latent TGFβ1 Inhibitor SRK-181 Phase 1 Clinical Trial, DRAGON,” will be available for on-demand viewing starting April 10, 2021.
Scholar Rock (NASDAQ:SRRK) has announced positive top-line results from the 12-month TOPAZ Phase 2 trial for apitegromab, aimed at treating Type 2 and Type 3 spinal muscular atrophy (SMA). Key findings include a 0.3-point decline in the Revised Hammersmith Scale (RHS) for ambulatory patients, with 57% maintaining or improving motor function. Non-ambulatory patients showed a 0.6-point improvement in the Hammersmith Functional Motor Scale Expanded (HFMSE). Cohort 3 reported a 7.1-point mean improvement in HFMSE. No major safety concerns were raised, with ongoing studies planned for additional indications.
Scholar Rock (NASDAQ: SRRK) announced the publication of preclinical data for SRK-181 in the International Journal of Toxicology. SRK-181 is a potent inhibitor of latent TGFβ1, aimed at overcoming resistance to checkpoint inhibitor therapy, and is currently in the DRAGON Phase 1 trial for solid tumors. The publication details SRK-181’s pharmacology, pharmacokinetics, and safety, supporting its clinical evaluation. Promising preclinical findings indicate a potentially improved safety profile compared to non-selective TGFβ inhibitors, with further clinical results expected by year-end.
Scholar Rock (NASDAQ: SRRK) has appointed Joshua Reed as an independent director on its Board of Directors. Reed, with over two decades of biopharmaceutical experience, will also chair the audit committee. His background includes significant roles at Aldeyra Therapeutics and Bristol-Myers Squibb. The company emphasizes that Reed's operational and strategic expertise is crucial at this stage of its growth, particularly as it aims to advance innovative treatments for serious diseases such as spinal muscular atrophy and cancer. Reed expressed enthusiasm about joining the team to drive transformative milestones.
Scholar Rock (NASDAQ: SRRK) announced the issuance of U.S. Patent No. 10,946,036, expiring June 2037, which covers myostatin inhibitor and neuronal corrector therapy for Spinal Muscular Atrophy (SMA). CEO Tony Kingsley expressed enthusiasm for this patent, anticipating top-line results from the apitegromab TOPAZ Phase 2 trial next quarter. The patent claims are broad and also granted in Japan and Europe. SMA affects 30,000 to 35,000 patients in the U.S. and Europe, highlighting the need for new therapies addressing muscle atrophy.
Scholar Rock (NASDAQ: SRRK) has announced the presentation of interim data from the TOPAZ Phase 2 clinical trial of apitegromab at the 2021 MDA Virtual Clinical Conference. The study focuses on apitegromab, a selective myostatin inhibitor for treating Type 2 and Type 3 Spinal Muscular Atrophy (SMA). Interim data from the trial will be shared in both an oral presentation on March 18 and a virtual poster available from March 15-18. Full 12-month data is anticipated in Q2 2021. Apitegromab has received Orphan Drug Designation from the FDA and the European Commission.
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