NeuLara (ustekinumab biosimilar) / NeuClone, Serum Institute of India - LARVOL DELTA

NeuClone Announces Positive Results from Phase I Study of Stelara (ustekinumab) Biosimilar Candidate (Businesswire) - P1; N=210; Sponsor: NeuClone Proprietary Limited; "NeuClone Pharmaceuticals Ltd (NeuClone) today announced its biosimilar candidate of Stelara® (ustekinumab), NeuLara, has successfully met all primary and secondary endpoints in a Phase I clinical trial. This includes all pre-specified criteria demonstrating the clinical pharmacokinetic (PK) similarity of NeuLara, compared to US- and EU-sourced Stelara®....'We are on track for a global Phase III trial starting in 2021 and to be among the first biosimilar entrants, making this valuable antibody drug available to many more patients with psoriasis and inflammatory bowel diseases.'"

New P3 trial • P1 data • Crohn's disease • Immunology • Inflammatory Bowel Disease

NeuClone Developing Biosimilars of PD-1 Inhibitors (Center for Biosimilars) - "NeuClone has completed phase 1 testing for its ustekinumab biosimilar (NeuLara) and published the results in April 2020...Ustekinumab is used for the treatment of plaque psoriasis and psoriatic arthritis."

P1 data • Trial completion • Immunology • Psoriasis

NeuClone announces completion of subject visits in Stelara (ustekinumab) biosimilar phase I clinical trial (Businesswire) - "NeuClone...announced successful completion of monitoring visits and blood sampling for subjects in the Phase I clinical trial for its Stelara® (ustekinumab) biosimilar candidate, NeuLara....The final clinical study report is anticipated in 3Q 2020."

P1 data • Trial status

NeuClone completes dosing in phase I clinical trial of Stelara (ustekinumab) biosimilar candidate (Businesswire) - "NeuClone Pharmaceuticals Ltd (NeuClone)...today announced successful recruitment and dosing of all subjects in the Phase I clinical trial for its Stelara® (ustekinumab) biosimilar candidate, NeuLara. The final subject was dosed last week....Recruitment was completed ahead of schedule, with all doses successfully administered within two months. The final clinical study report is anticipated in 3Q 2020....'Our aim is to bring NeuLara to market as soon as possible so patients suffering from psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis'...NeuClone remains open to potential development and commercialisation collaborations."

Licensing / partnership • P1 data • Trial status

NeuClone announces first human dose of Stelara (ustekinumab) biosimilar candidate in Phase I clinical trial (Businesswire) - "NeuClone...announced it has commenced dosing of Stelara® (ustekinumab) biosimilar candidate, NeuLara, in a Phase I clinical trial...The NeuLara Phase I clinical trial is being conducted under the Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification (CTN) scheme. This pathway offers a streamlined approach and data output is supported by global regulatory agencies such as the EMA and U.S. FDA."

Trial status

NeuClone to initiate phase I clinical trial of Stelara (ustekinumab) biosimilar, the second biosimilar from the 10-product portfolio with Serum Institute (PRNewswire) - "NeuClone Pharmaceuticals Ltd....today announced it will initiate the Phase I clinical trial of its Stelara® (ustekinumab) biosimilar in the second half of 2019....NeuClone's Stelara® (ustekinumab) biosimilar is called 'NeuLara'. The multicentre Phase I trial of NeuLara will be conducted in Australia under the Clinical Trial Notification (CTN) scheme of the Therapeutic Goods Administration (TGA). The trial will be...comparing the pharmacokinetics and safety of NeuLara, to US- and EU-sourced Stelara® in healthy volunteers....NeuClone representatives will attend the upcoming 2019 BIO conference in Philadelphia from 3-6th June and look forward to discussing biosimilar development and commercialisation opportunities with potential partners."

Licensing / partnership • New P1 trial

"NeuClone to Initiate P-I Clinical Study of Stelara (ustekinumab, biosimilar) in Australia https://t.co/0cyyQpnvgO" (@Pharmashot)

Clinical