FDA approves Merck’s Keytruda plus chemotherapy for advanced malignant pleural mesothelioma
- The FDA has approved Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy for first-line treatment of unresectable advanced or metastatic malignant pleural mesothelioma (MPM).
- Approval is based on the Phase 2/3 IND.227/KEYNOTE-483 trial, which showed a 21% reduction in the risk of death compared to chemotherapy alone.
- Keytruda plus chemotherapy also improved progression-free survival (PFS) and overall response rate (ORR) compared to chemotherapy alone.
- The trial enrolled 440 patients and demonstrated significant improvements in overall survival (OS), PFS, and ORR.
Read more
argenx announces publication in The Lancet Neurology of pivotal ADHERE study data in chronic inflammatory demyelinating polyneuropathy
- ADHERE was the largest and most innovative clinical trial of CIDP patients to date.
- VYVGART Hytrulo demonstrated a 61% reduction in disease progression and reduced risk of relapse.
- The study showed rapid onset of action, with significant improvements in mobility, function, and strength.
- 99% of trial participants elected to participate in the ADHERE open-label extension.
Read more
Anokion announces new data from the phase 1 MoveS-it study supporting ANK-700 for relapsing-remitting multiple sclerosis
- Anokion presented new data at the 40th Congress of ECTRIMS in Copenhagen, Denmark.
- The Phase 1 MoveS-it study evaluated the safety and tolerability of ANK-700 in 34 patients with RRMS.
- ANK-700 showed no Serious Adverse Events (SAEs) and no evidence of disease exacerbation.
- Pre-clinical data demonstrated the potential of ANK-700 in expanding antigen-specific regulatory T-cells.
Read more
Alzprotect announces supportive results from open-label extension of phase 2a study for progressive supranuclear palsy
- Alzprotect completed the open-label extension (OLE) phase following the Phase 2a trial of AZP2006 for PSP.
- Patients on AZP2006 showed delayed disease progression and stabilization, especially when treated early.
- Even late-stage PSP patients who started AZP2006 in the OLE phase experienced stabilization.
- No significant safety concerns were observed during the OLE phase.
Read more
New Alzheon peer-reviewed publication on APOLLOE4 phase 3 trial design and baseline characteristics
- Alzheon published a new scientific paper on the APOLLOE4 Phase 3 trial, focusing on APOE4/4 homozygotes with early Alzheimer's disease.
- The trial is a 78-week, randomized, double-blind, placebo-controlled study involving 325 subjects aged 50-80 years.
- ALZ-801/valiltramiprosate, the investigational oral therapy, aims to block neurotoxic beta amyloid oligomers and has shown favorable safety results.
- Topline data from the trial is expected in late 2024, with a long-term extension study ongoing in the US, UK, and Canada.
Read more
IGC Pharma announces additional data supporting IGC-AD1 as an Alzheimer's treatment
- IGC Pharma's IGC-AD1 shows promising effects on tau tangles and spatial memory.
- Preclinical studies reveal IGC-AD1 reduces hyperphosphorylation of tau protein by approximately 10%.
- Morris Water Maze tests indicate a 50% faster reduction in escape latency times in treated mice.
- IGC-AD1 is in a Phase 2 clinical trial for treating agitation in dementia due to Alzheimer's.
Read more
Xspray Pharma announces positive FDA meeting and plans for Dasynoc NDA resubmission
- Xspray Pharma plans to resubmit its NDA for Dasynoc in Q4 2024, following a productive meeting with the FDA.
- The FDA recommended adjustments to Dasynoc's tablet strengths to reduce medication errors, requiring new batches to be produced.
- Xspray Pharma has initiated production of these new batches and will provide further clarification on the manufacturing process.
- A new PDUFA date will be assigned upon resubmission, with a final decision expected within two to six months.
Read more
InnoCare announces approval of clinical trial of BCL2 inhibitor ICP-248 for acute myeloid leukemia in China
- InnoCare Pharma received approval for an Investigational New Drug (IND) to conduct a clinical trial of BCL2 inhibitor ICP-248 in combination with azacitidine for acute myeloid leukemia (AML) in China.
- AML is a malignant hematological disease originating from hematopoietic stem/progenitor cells, accounting for about 80% of acute leukemia in adults.
- ICP-248 is a novel, orally bioavailable BCL2-selective inhibitor that selectively inhibits BCL2 and restores the mechanism of programmed cell death.
- InnoCare aims to accelerate the clinical development of ICP-248 to benefit patients with hematological malignancies.
Read more
Azitra receives fast track designation for ATR-04 for skin rash from EGFR inhibitors
- Azitra, Inc. has been granted Fast Track Designation by the FDA for ATR-04, a treatment for moderate to severe EGFR inhibitor-associated dermal toxicity.
- ATR-04 is a live biotherapeutic product containing a genetically engineered strain of Staphylococcus epidermidis.
- The Fast Track Designation aims to expedite the development and review process, potentially allowing for accelerated approval or rolling review.
- Azitra plans to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial of ATR-04 by the end of 2024.
Read more