This week on Pipeline Moves, we bring positive news from two major big pharma players. Eli Lilly completed a Phase II trial of an antibody being developed for rheumatoid arthritis, and Pfizer finished a Phase I study in colorectal cancer. To round out a positive week, we look into two more trial completions in retinal vein occlusion and Raynaud’s disease.
Lilly completes rheumatoid arthritis trial
Eli Lilly’s peresolimab (LY3462817) saw its Phase Transition Success Rate (PTSR) improve in autoimmune disorders, after the completion of a Phase II study in rheumatoid arthritis. The PSTR increased by ten points reaching 36% in autoimmune disorders. The Phase II trial’s status was updated on its ClinicalTrials.gov listing from “Active, not recruiting” to “Completed” on August 10, with GlobalData evaluating the asset the next day.
The Phase II trial (NCT04634253) investigated the safety and efficacy of peresolimab in 101 adult participants with moderately to severely active rheumatoid arthritis (RA). The trial’s primary endpoint measured changes in the disease activity score within 12 weeks. The secondary endpoints measured the drug’s concentration in the blood, the percentage of participants achieving 20% improvement in rheumatology criteria as well as changes in other disease activity indexes over a period of 12 weeks.
Peresolimab is a PD-1 agonist monoclonal antibody under development for the treatment of moderately to severely active rheumatoid arthritis and other autoimmune diseases. It elicits a therapeutic effect and keeps the disease in check by binding to PD-1 receptors expressed in immune cells to trigger their programmed cell death.
Pfizer finishes Phase I cancer study
Pfizer’s Talzenna (talazoparib) saw its PTSR rise by seven points to 69% in colorectal cancer after a Phase I trial completion. The study’s (NCT04672460) ClinicalTrials.gov page changed from “Active, not recruiting” to “Completed” on August 5, with GlobalData appraising the asset on August 8.
The Phase I trial compared liquid-filled, soft gelatin capsule talazoparib versus the approved hard capsule Talzenna. The trial investigated bioequivalence between both formulations, and is a food effect study of the soft capsule version. The trial, which recruited patients with solid tumors, was initially expected to enrol 46 subjects but finished with 74.
Hard capsule Talzenna was approved by the FDA in October 2018 for HER2 negative breast cancer. Talzenna is a poly ADP-ribose polymerase (PARP) inhibitor.
Kodiak completes Phase III trial
Kodiak Sciences’s KSI-301 (tarcocimab tedromer) saw its Likelihood of Approval (LoA) in retinal vein occlusion (RVO) jump by 15 points to 23% after the publication of positive Phase III topline data.
Topline results from the Phase III BEACON study (NCT04592419) was unveiled in a company press release on August 8. GlobalData evaluated the asset’s LoA on August 10. LoA is identified via GlobalData’s analysis using a combination of machine learning and its proprietary algorithm. LoA can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.
The 568-subject study recruited patients with macular edema due to RVO. The study met its primary endpoint of noninferior change from baseline in visual acuity at week 24 as compared to Regeneron Pharmaceuticals and Bayer’s Eylea (aflibercept). Patients in the tarcocimab arm received only four doses, versus six with Eylea in the first 24 weeks of study. Kodiak aims to release full primary results at ophthalmology congresses this September.
Anti-VEGF treatment tarcocimab is also in Phase III trials for diabetic macular edema, wet age-related macular degeneration, and diabetic retinopathy. If successful, data from these Phase III studies would be used as part of a single Biologics License Application, as per August 8 press release.
Gesynta wraps up Phase II Raynaud’s disease trial
Gesynta Pharma’s GS-248 saw its PTSR in two indications rise after the completion of a Phase II study. The PTSR sprung by 10 points to 30% in systemic sclerosis and by nine points to 33% in Raynaud’s disease.
The Phase II’s (NCT04744207) ClinicalTrials.gov page was updated from “Active, not recruiting” to “Completed” on August 3, with GlobalData appraising the asset the following day. Phase II data is expected in the fall of 2022, as per a July 12 press release shared by Gesynta, which also announced the completion of the trial’s recruitment then. The study aimed to enrol 80 subjects but closed with 69 participants, as per ClinicalTrials.gov.
The placebo-controlled Phase II investigated daily oral capsule GS-248 in Raynaud’s disease and peripheral vascular blood flow in participants with systemic sclerosis. Sometimes referred to as Raynaud’s phenomenon, Raynaud’s disease results in a decreased blood flow to the fingers and toes, leading to numbness and color change. As such, as an efficacy coprimary endpoint, the study investigated the mean change in the number of patient-reported Raynaud’s attacks up to week four.
GS-248 was initially developed by Orexo AB and was originally known as OX-MPI. Orexo partnered with Gesynta, who was given the rights to the asset in October 2017.
Need to Know:
GlobalData’s proprietary model uses a combination of machine learning and an algorithm to calculate an individual drug’s PTSR and LoA. While LoA provides the probability of a drug ultimately receiving market authorization, PTSR indicates the probability of a drug’s advancement to the next stage of clinical development. The model uses data points from the individual drugs, clinical trials, regulatory milestones, company, and financial databases.