This week on Pipeline Moves, we start the week by looking at the completion of the Phase III trial investigating oral semaglutide. We also review trial completions in dry eye disease, renal stones, and psoriasis. We finish off by investigating the termination of a trial in haematological malignancies.

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Completion of Phase IIIa trial with semaglutide

Novo Nordisk’s oral semaglutide (NN-9932) saw its Likelihood of Approval (LoA) rise by 10 points to 50% after the completion of a Phase IIIa study. LoA is identified via GlobalData’s analysis using a combination of machine learning and a proprietary algorithm. LoA can be calculated for a drug by considering characteristics like therapy area, indication and molecule type.

The trial’s status changed from ongoing, not recruiting to completed on 22 May, with the asset’s LoA being updated the next day.

The Phase IIIa study (NCT05035095) study enrolled 667 overweight or obese patients. It aimed to evaluate the safety, tolerability, and superior efficacy on body weight reduction in overweight or obese patients taking oral semaglutide 50 mg once daily versus placebo as an adjunct to a reduced-calorie diet and increased physical activity.

As per a Novo Nordisk press release announcing headline results, semaglutide achieved 15.1% weight loss from a mean baseline body weight in all evaluated patients regardless of treatment adherence. When readjusted to include only patients who adhered to treatment, the percentage rose to 17.4%. For the placebo group, there was a 1.8% reduction. After 68 weeks, 89.2% of those who received the drug reached a weight loss of 5% or more, compared to 24.5% of placebo subjects.

Novo Nordisk’s injectable semaglutide is currently marketed as Ozempic for use as an adjunct to diet and exercise to improve glycemic control specifically in adults with type 2 diabetes mellitus. Semaglutide improves the efficiency of incretin function by binding to and activating GLP-1 receptors. It increases insulin secretion, supresses glucagon secretion, and slows gastric emptying.

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Completion of Phase II dry eye trial

Aramis Biosciences’s A-197 saw its Phase Transition Success Rate (PTSR) in keratoconjunctivitis sicca spring after the completion of a Phase II trial.  The PTSR grew by 10 points to 36%. PTSR is the probability, given as a percentage, of a drug progressing successfully from one development stage to the next.

The study’s status on its page switched from active, not recruiting to completed on 16 May, with GlobalData updating the PTSR the next day. Also known as dry eye disease, keratoconjunctivitis sicca causes eye irritation and other symptoms. A-197 is a first-in-class immunomodulatory agent for the condition, based on the company’s website.

The Phase II trial (NCT05238597) investigated the efficacy, safety and tolerability of an ophthalmic solution of A-197 compared to vehicle control in patients with keratoconjunctivitis sicca. The trial investigated the change from baseline in total corneal fluorescein staining (CFS) at a 12-week timeframe as the primary endpoint.

Investigator-led Phase II trial in renal stones completed

Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) saw its PTSR in renal stones grow after the completion of an investigator-led Phase II trial. The PTSR rose by 10 points to 24%.

The study’s status on its listing changed from active, not recruiting to completed on 12 May, with GlobalData appraising the asset on 15 May.

The Phase II study (NCT04911660) investigated the use of Jardiance on urinary supersaturations in patients with kidney stones. The 50-patient trial was sponsored by the Inselspital, also known as the University Hospital of Bern, Switzerland. The primary endpoint measured the supersaturation of urine with calcium oxalate, calcium phosphate and uric acid.

Jardiance is marketed as a treatment for type 2 diabetes and heart failure. It is a sodium-glucose cotransporter-2 inhibitor, which lowers hepatic glucose production and ameliorates glucotoxicity.

Healthy volunteer trial completed in psoriasis

Huabo Biopharm’s HB-0034 saw its PTSR rise in generalised pustular psoriasis (GPP) after a Phase I trial was completed. The drug’s PTSR grew by seven points to 16%.

The trial’s status (NCT05460455) was updated from active, not recruiting to completed on on 9 May, and GlobalData evaluated the asset on the following day. The aim of the study was to investigate the safety and tolerability of HB-0034 in healthy subjects following multiple doses. The trial enrolled 30 patients.

HB-0034 is a monoclonal antibody (mAb) that elicits anti-inflammatory properties by antagonizing the interleukin-36 receptor. The mAb is under development for the treatment of pustular psoriasis, systemic lupus erythematosus, and ulcerative colitis.

Termination of investigator-led haematological malignancies trial

ADC Therapeutics’s ADCT-301 (camidanlumab tesirine) saw its PTSR decline in haematological malignancies after an investigator-led Phase II trial was terminated. The PTSR decreased by 20 points to 11% in myeloproliferative disorders and by 19 points to 12% in myelodysplastic syndrome.

GlobalData evaluated the asset on 15 May after a update on 12 May. The trial was terminated because ADC Therapeutics is reallocating all resources to the Phase III program, according to the trial listing. There is no Phase III trial listed for camidanlumab tesirine on, nor has the company outlined any plans in its Q1 earnings. The Phase II trial was sponsored by Duke University.

The open-label trial (NCT04639024) recruited three out of the 10 planned patients with relapsed or refractory acute myeloid leukaemia, myelodysplastic syndrome, or myeloproliferative neoplasms. The aim of the trial was to evaluate the safety and efficacy of ADCT-301. ADCT-301 targets CD25, which is a cell-surface antigen that is overexpressed in tumour cells.

Read the last edition:

Pipeline Moves: Hengrui Medicine Phase III breast cancer termination lowers approval prospects

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.