Scholar Rock Holding Corp (SRRK)
Scholar Rock Holding Corporation is a biopharmaceutical firm dedicated to discovering and advancing treatments for severe medical conditions by targeting the crucial role of protein growth factor signaling. Their lead therapeutic candidate, Apitegromab, an agent designed to inhibit the activation of latent myostatin, has successfully concluded Phase 3 clinical trials for spinal muscular atrophy (SMA). Another key program, SRK-181, is currently undergoing Phase 1 clinical assessment for tackling cancers that exhibit resistance to established checkpoint inhibitor treatments, including anti-PD-1 or anti-PD-L1 antibody therapies. Beyond these, the company cultivates a robust pipeline of innovative potential therapies, aiming to significantly improve the lives of individuals grappling with various severe ailments, such as neurological muscle conditions, malignancies, and fibrotic disorders. In a strategic partnership, Scholar Rock is collaborating with Gilead Sciences, Inc. to identify and develop targeted inhibitors of transforming growth factor beta (TGF-beta) activation, specifically for addressing fibrotic diseases. Established in 2012, Scholar Rock Holding Corporation operates from its headquarters in Cambridge, Massachusetts.
Sector: Biological Products, (No Diagnostic Substances)
Industry: Biotechnology
Scholar Rock Holding Corporation
Trials need funding. See this company's dilution risk and cash position.
- Phase 3Completed
Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam
Apitegromab, Placebo
Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 3 +8
NCT05156320Enrollment188StartApr 2022Primary CompletionDec 2024CompletionDec 2024 - Phase 3Active, not recruiting
Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab
Apitegromab
Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 3 +8
NCT05626855Enrollment238StartApr 2023Primary CompletionNov 2026est.CompletionMay 2029est. - Phase 2Completed
An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular Atrophy
SRK-015
Spinal Muscular Atrophy, Spinal Muscular Atrophy Type 3 +7
NCT03921528Enrollment58StartApr 2019Primary CompletionJan 2021CompletionFeb 2024 - Phase 2Completed
Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese
Apitegromab, Placebo
Overweight and Obesity
NCT06445075Enrollment102StartMay 2024Primary CompletionMar 2025CompletionJun 2025 - Phase 2Recruiting
A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy
Apitegromab, Nusinersen
Spinal Muscular Atrophy, SMA +4
NCT07047144Enrollment52StartSep 2025Primary CompletionNov 2028est.CompletionMar 2029est. - Phase 2Recruiting
Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD
Apitegromab, Placebo
Facioscapulohumeral Muscular Dystrophy, FSHD
NCT07435129Enrollment60StartJul 2026Primary CompletionJun 2028est.CompletionDec 2028est. - Phase 1Completed
SRK-181 Alone or in Combination With Anti-PD-(L)1 Antibody Therapy in Patients With Locally Advanced or Metastatic Solid Tumors (DRAGON)
SRK-181, anti-PD-(L)1 antibody therapy
Cancer
NCT04291079Enrollment112StartApr 2020Primary CompletionApr 2025CompletionApr 2025 - Phase 1Recruiting
A Single- and Multiple-Ascending Dose Study of SRK-439 in Healthy Adults
Placebo, SRK-439
Healthy
NCT07444294Enrollment76StartNov 2025Primary CompletionDec 2026est.CompletionJun 2027est. - Expanded accessNo longer available
EAP of Apitegromab for Patients With Spinal Muscular Atrophy
Apitegromab
SMA
NCT06877689Enrollment-Start-Primary Completion-Completion-
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 3 | Completed | Apitegromab, Placebo | NCT05156320 |
| Phase 3 | Active, not recruiting | Apitegromab | NCT05626855 |
| Phase 2 | Completed | SRK-015 | NCT03921528 |
| Phase 2 | Completed | Apitegromab, Placebo | NCT06445075 |
| Phase 2 | Recruiting | Apitegromab, Nusinersen | NCT07047144 |
| Phase 2 | Recruiting | Apitegromab, Placebo | NCT07435129 |
| Phase 1 | Completed | SRK-181, anti-PD-(L)1 antibody therapy | NCT04291079 |
| Phase 1 | Recruiting | Placebo, SRK-439 | NCT07444294 |
| Expanded access | No longer available | Apitegromab | NCT06877689 |