This week on Pipeline Moves, we kick off by looking at the completion of a Phase II/III trial for relapsing multiple sclerosis. Meanwhile, Shanghai Fosun Pharmaceutical has terminated a Phase I/II solid tumour trial. On a good note, we investigate completions a Phase II trial for wet age-related macular degeneration, a Phase II trial for substance abuse, a Phase I/II trial in HER2-negative breast cancer and a Phase I/II trial in basal cell carcinoma.

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Phase II/III success for RMS candidate

Clene Nanomedicine’s CNMAU-8 saw its Phase Transition Success Rate (PTSR) increase in relapsing multiple sclerosis (RMS) after a Phase II/III trial in the same indication was completed. The drug’s PTSR rose by seven points to 60% in RMS.

PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The Phase II/III trial’s (NCT04626921) status was updated from active, not recruiting to complete on ClinicalTrials.gov on 11 December, and GlobalData evaluated the asset on the same day.

The open-label, long-term extension study evaluated the efficacy and safety data of CNMAU-8 in adult participants who had completed the CNMAu8.201 (VISIONARY-MS) study. The study initially intended to recruit 150 subjects, but only ended up enrolling only 55 subjects.

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By GlobalData

The drug candidate is a nanocrystalline gold suspension which evokes remyelination of the spinal cord and optic nerve by stimulating the production of the myelin sheath. The asset acts by inhibiting the ability of damaging events leading to demyelination to protect the neurons.

Clene Nanomedicine is a private subsidiary company with headquarters in Salt Lake City, Utah.

Wet AMD Phase II trial completion

EyePoint Pharmaceuticals’s vorolanib (EYP-1901) saw its PTSR rise by 17 points to 52% in wet age-related macular degeneration (AMD) after achieving all primary and secondary endpoints in a Phase II trial.

EyePoint announced that both doses of vorolanib (2mg and 3mg) achieved all primary and secondary endpoints in the Phase II study (NCT05381948) in a 4 December press release. GlobalData evaluated the asset on 6 December. In meeting the primary endpoint, both vorolanib doses demonstrated statistical non-inferiority change in best corrected visual acuity (BCVA) compared to aflibercept control.

The trial also achieved key secondary endpoints with both vorolanib doses, including an over 80% reduction in treatment burden, nearly two-thirds of eyes were supplement-free for up to six months and over 80% receiving only zero or one supplement for up to six months.

The results also reported a continued positive safety and tolerability profile with no EYP-1901-related ocular or systemic serious adverse events (SAEs). Patient discontinuation up to week 32 was low at 4%.

Vorolanib is a vascular endothelial growth factor (VEGF) inhibitor. VEGF promotes its signalling through the VEGF receptor (VEGFR). VEGF signalling modulates angiogenesis, which involves making of new blood vessels from existing blood vessels.

Completion of Phase II substance abuse trial

PleoPharma’s PP-01 saw its PTSR rise in substance abuse disorder by 10 points to 35% after the completion of a Phase II study.

The Phase II trial’s (NCT05494437) status was updated from active, not recruiting to completed on ClinicalTrials.gov on 6 December and GlobalData appraised the asset the next day.

The trial studied if PP-01 reduces withdrawals associated with discontinuing cannabis in 234 subjects with moderate to severe cannabis use disorder, based on the trial’s listing. The trial used the evaluation of a patient reported outcome measure of cannabis withdrawal over five days as its primary endpoint.

PP-01 is an orally administered drug that works through an undisclosed mechanism.

Phase I/II basal cell carcinoma trial completes

AiViva BioPharma’s AIV-001 saw its PTSR rise in basal cell carcinoma and non-melanomatous skin cancer after the completion of a Phase I/II study.

The PTSR rose by nine points to 34% in basal cell carcinoma while growing by 10 points to 27% in non-melanomatous skin cancer.

The company announced the Phase I/II trial’s (NCT04470726) completion in a 11 December press release, with GlobalData appraising the asset the next day.

The 26-subject trial studied the efficacy, safety, and skin tolerability of AIV001 in four ascending dose cohorts. The company now has multiple options for the compound’s further development, which includes seeking strategic partnerships, based on the 11 December press release.

AIV101 is a novel formulation of a multi-kinase inhibitor combined with AiViva’s proprietary delivery technology that is administered intradermally. The compound is designed for the treatment of different dermatological conditions such as rosacea by targeting vascular endothelial growth factors (VEGF) and limiting inflammation and fibrosis.

Phase I/II HER2-negative breast cancer trial completion

Dantari’s DAN-222 saw its PTSR increase in human epidermal growth factor receptor 2 negative breast cancer (HER2-negative breast cancer) after a Phase I/II trial was completed.

The drug’s PTSR increased by nine points, reaching 42%.

The Phase I/II trial’s (NCT05261269) status was updated from active, not recruiting to completed on ClinicalTrials.gov on 13 December and GlobalData evaluated the asset on the following day.

The purpose of the dose escalation study was to evaluate the safety and pharmacology of DAN-222 in metastatic breast cancer patients. The study enrolled 30 patients.

DAN-222 is a polymeric nanoparticle conjugated with camptothecin, a topoisomerase I inhibitor.

Phase I/II solid tumour trial terminated

Shanghai Fosun Pharmaceutical’s ORIN-1001 saw an 11-point drop in its PTSR landing at 12% in solid tumour, following a Phase I/II trial termination.

In an 8 December overseas regulatory announcement, the company declared that the trial (NCT05154201) would be terminated after an evaluation of the investment on development and clinical value of the drug. GlobalData evaluated the asset on 11 December.

Shanghai Fosun said that it will reallocate resources towards research and development for the rest of its clinical pipeline. The Phase I/II dose-finding and dose expansion study investigated ORIN-1001’s tolerability and efficacy in patients with advanced solid tumours.

ORIN-1001 is an oral therapy that inhibits inhibiting IRE1, triggering antineoplastic activity. The Shanghai, China-headquartered pharmaceutical company is also developing the drug as a treatment for idiopathic pulmonary fibrosis.

Phase I solid tumour trial completes

Yisheng Biopharma’s YSON-001 saw its Phase Transition Success Rate (PTSR) increase in metastatic breast cancer after a Phase I trial was completed. The drug’s PTSR increased by nine points, reaching 66%. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The Phase I trial’s (NCT03131765) status was updated from active, not recruiting to completed on ClinicalTrials.gov on 5 December and GlobalData evaluated the asset on 11 December.

The purpose of the study was to evaluate the tolerability and safety of YSON-001 in patients with advanced solid tumours. The study enrolled 31 patients.

YS-ON-001 elicits immunostimulant properties. The Beijing, China-based company is developing the vaccine candidate for the treatment of hepatocellular carcinoma, pancreatic cancer, breast cancer, metastatic breast cancer, lung cancer, liver cancer, melanoma, colorectal cancer, prostate cancer, and other solid tumours.

Read the last edition:

Pipeline Moves: Approval prospects rise for Mirum’s rare disease candidate after trial completion

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.