This week on Pipeline Moves, we kick off by looking at the completion of a Phase III trial of BioTissue's diabetic foot ulcer candidate.
Meanwhile, Spruce Biosciences terminated a Phase II trial of its candidate tildacerfont in adrenal hyperplasia.
On a positive note, both Bristol Myers Squibb and Regeneron have both reported trial completions in hepatocellular carcinoma and thromboembolism, respectively.
Approval prospects for BioTissue’s TTAX-01 up after Phase III completion
BioTissue’s TTAX-01 saw its Likelihood of Approval (LoA) rise after a Phase III trial was completed. The LoA increased by five points to 10% in diabetic foot ulcers.
The Phase III trial’s (NCT04176120) status was updated from ongoing to completed on ClinicalTrials.gov on 14 June with GlobalData evaluating the product on 17 June.
The multi-centre study evaluated TTAX-01 for late stage, complex non-healing diabetic foot ulcers. The trial enrolled 220 patients.
TTAX-01 consists of cryopreserved human umbilical cord product derived from donated human placental tissue and is under development for diabetic foot ulcers.
LoA is determined using a combination of machine learning and GlobalData’s proprietary algorithm. It can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.
Phase transition prospects rise after Phase II PXE completion
Daiichi Sankyo’s DS-1211 saw its Phase Transition Success Rate (PTSR) increase after a Phase II trial was completed. The drug candidate’s PTSR increased by ten points in Pseudoxanthoma elasticum (PXE or Gronblad Strandberg Syndrome) reaching 26%. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.
The Phase II trial’s (NCT05569252) status was updated from active, not recruiting to completed on ClinicalTrials.gov on 14 June, and GlobalData evaluated the asset on 17 June.
The purpose of the randomised, placebo-controlled, double-blind trial was to study DS-1211 in Pseudoxanthoma elasticum. The study enrolled 64 patients.
DS-1211 acts as a tissue non-specific alkaline phosphatase inhibitor (TNAP) and is under development for the treatment of Pseudoxanthoma elasticum.
Phase II trial congenital adrenal hyperplasia terminated
Spruce Biosciences’s tildacerfont saw its PTSR decrease in congenital adrenal hyperplasia (adrenogenital syndrome) after a Phase II trial was terminated. The PTSR dropped by ten points to 43%.
The Phase II trial’s (NCT04457336) status was updated from completed to terminated on ClinicalTrials.gov on 10 June, and GlobalData evaluated the asset on the following day.
According to the study’s ClinicalTrials.gov listing, the sponsor terminated the study due to it “not meeting its primary or secondary endpoints”.
The purpose of the randomised, double-blind, placebo-controlled, dose-ranging study was to evaluate the safety and efficacy of tildacerfont. The study enrolled 96 patients.
Tildacerfont (SPR-001) acts as corticotropin-releasing factor receptor 1 (CRHR1) antagonist and is under development for the treatment of classic congenital adrenal hyperplasia, major depressive disorder (MDD) and polycystic ovary syndrome.
BMS completes Phase II HCC trial
Bristol Myers Squibb’s BMS-813160 saw its PTSR in hepatocellular carcinoma (HCC) increase by nine points to 38% after an investigator-led Phase II study was completed.
The Phase II trial’s (NCT04123379) status was updated from active, not recruiting to completed on ClinicalTrials.gov on 5 June, with GlobalData evaluating the product on 10 June. The study was sponsored by Icahn School of Medicine at Mount Sinai. The trial enrolled patients with HCC or non-small cell lung cancer (NSCLC).
The randomised, parallel assignment, open label study evaluated the effects of BMS’s PD-1 inhibitor Opdivo (nivolumab) dosed in combination with the CCR2/5 inhibitor BMS-813160, or anti-interleukin-8 (IL-8), which was also called BMS-986253, before and after surgery.
The primary purpose of the study was to determine whether the neoadjuvant treatment resulted in a “significant” immune response against the tumour, and improvements in long term survival rates. The co-primary endpoints of the study were major pathologic response (MPR), which was defined by the presence of <10% viable tumour within resection at the time of surgery and significant tumour necrosis (STN) of >70% at the time of surgery.
Regeneron completes Phase II thromboembolism trial
Regeneron Pharmaceuticals’s REGN-9933 saw PTSR increase in thromboembolism after a Phase II trial was completed. The drug candidate’s PTSR increased by six points in venous thromboembolism reaching 49%.
The Phase II trial’s (NCT05618808) status was updated from active, not recruiting to completed on ClinicalTrials.gov on 6 June, and GlobalData evaluated the asset on the following day.
The purpose of the multi-centre, randomised, active-controlled, open-label study was to learn how well REGN-9933 works for preventing blood clots after knee replacement surgery. The study enrolled 373 patients.
REGN-9933 acts by inhibiting coagulation factor XI. The drug candidate is under development for the prevention of venous thromboembolism after elective, unilateral, total knee arthroplasty.
Phase I migraine trial completion
Biohaven’s BHV-2100 saw a seven-point increase in its PTSR, settling at 64% in migraine following a Phase I trial completion and the release of preliminary results.
The Connecticut, US-headquartered company released a press release announcing the Phase I trial completion and sharing preliminary results from the study on 29 May. GlobalData evaluated the asset on 3 June.
The Phase I placebo-controlled trial evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of BHV-2100 in healthy subjects. Data from the trial showed that drug concentrations were above the EC90 target and well tolerated. In the press release, Biohaven announced plans to advance the candidate to Phase III.
BHV-2100 is a transient receptor potential cation channel subfamily M member 3 (TRPM3) blocker. The therapy acts by activating TRPM3 to reverse hypersensitivity, eliciting analgesic activity.
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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 datapoints from individual drugs, clinical trials, regulatory milestones, company, and financial databases.
"Pipeline Moves: Approval prospects for BioTissue’s diabetic foot ulcer drug up after Phase III completion" was originally created and published by Clinical Trials Arena, a GlobalData owned brand.
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