CASI Pharmaceuticals Announces Dose Escalation in Phase 1 CID-103 ITP Study
Breakthrough Clinical Results
CASI Pharmaceuticals announced that the Safety Monitoring Committee (SMC) recommended dose escalation of CID-103, an anti-CD38 monoclonal antibody, to the next cohort in a Phase 1 study for immune thrombocytopenia (ITP). The SMC's recommendation follows a review of the first four cohorts, showing a favorable safety profile with no serious adverse events or dose-limiting toxicities. The study will continue to enroll up to 30 patients with ITP across five dose cohorts. CASI is also pursuing development of CID-103 for organ transplant rejection, with an FDA IND clearance for a Phase 1 study in renal allograft antibody-mediated rejection.
Key Highlights
- Safety Monitoring Committee recommends dose escalation of CID-103 to 900mg in Phase 1 ITP study.
- No serious adverse events or dose-limiting toxicities reported in the first four cohorts.
- Study to continue enrolling up to 30 patients with ITP.
- CASI also pursuing CID-103 development for organ transplant rejection.
Incidence and Prevalence
Latest Estimates of Immune Thrombocytopenia Incidence and Prevalence
Recent epidemiological data from a 2021 retrospective analysis using Texas Medicaid claims (2012-2015) provides some insights into Immune thrombocytopenia (ITP) prevalence:
- The average annual prevalence of ITP was 17.0 per 100,000 persons
- Prevalence was higher among females compared to males (17.4 vs 13.6 per 100,000)
- The highest prevalence was observed among adults aged ≥65 years (36.7 per 100,000)
This analysis also revealed important information about healthcare utilization among ITP patients:
- Among 325 patients studied, 49.2% received ITP therapies
- 70.5% had at least one all-cause emergency department visit
- 56.0% experienced at least one hospitalization
- 32.6% had at least one ITP-related ED visit
- 40.3% had at least one ITP-related hospitalization
- Children aged 0-4 and 5-17 were more likely to have ITP-related hospitalizations and ED visits compared to adults aged 18-49
Additionally, a 2023 study examining SARS-CoV-2 infection patients found:
- Out of 1200 patients, 436 (36.3%) had thrombocytopenia
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Among these patients:
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118 (27.1%) had mild thrombocytopenia
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75 (17.2%) had moderate thrombocytopenia
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42 (9.6%) had severe and very severe thrombocytopenia
CID-103 Clinical Trials Beyond Immune Thrombocytopenia
Based on a thorough review of the available information, there is insufficient data regarding clinical trials of CID-103 (anti-CD47 antibody) for indications beyond immune thrombocytopenia (ITP).
The current clinical development program for CID-103 appears to be focused primarily on immune thrombocytopenia as the main therapeutic target. Without access to complete and current clinical trial registries, it is not possible to definitively state which other indications this monoclonal antibody might be under investigation for.
Anti-CD47 antibodies as a class are being studied in various oncological conditions and hematological disorders due to their mechanism of action involving the CD47-SIRPα pathway, which plays a role in immune evasion by cancer cells. However, specific information about CID-103's expanded clinical program beyond ITP is not available in the current dataset.
Regarding intervention models for potential trials, typical designs for monoclonal antibody studies include:
- Dose-escalation protocols in early phase trials
- Randomized controlled trials comparing the agent to standard of care or placebo
- Open-label extension studies following initial efficacy demonstrations
For a comprehensive understanding of CID-103's complete clinical development program, including any trials for indications beyond immune thrombocytopenia, consultation of updated clinical trial registries such as ClinicalTrials.gov or direct information from the developing pharmaceutical company would be necessary.
As research in the field of anti-CD47 therapies continues to evolve, the therapeutic applications of CID-103 may expand to include additional indications based on emerging clinical data and mechanistic understanding of the CD47 pathway in various disease states.
