ORJ-001 / NIBEC, Oorja Bio - LARVOL DELTA

A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis (clinicaltrials.gov) - P1 | N=35 | Terminated | Sponsor: NIBEC Co., Ltd. | Completed ➔ Terminated; Study was terminated at the end of Part A for strategic reasons (not due to lack of efficacy or safety issues

Trial termination • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis (clinicaltrials.gov) - P1 | N=35 | Completed | Sponsor: NIBEC Co., Ltd. | Recruiting ➔ Completed | N=24 ➔ 35 | Trial completion date: May 2025 ➔ Sep 2025 | Trial primary completion date: Mar 2025 ➔ Jul 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Nivek announced on the 28th that it has signed a technology transfer contract worth up to $435 million (about 595.2 billion won) with a U.S.-based pharmaceutical bio company for “NP-201,“ a candidate for fibrosis treatment. (Maeil) - "The other party to this technology transfer contract is a U.S.-based company with R&D and commercialization capabilities in idiopathic pulmonary fibrosis (IPF) and pulmonary arterial hypertension (PAH). Through this agreement, Nivek will transfer exclusive rights to the global development and commercialization of NP-201. The down payment is $8 million (KRW 10.9 billion) and will be received within 30 days from the effective date of the contract. The contract also included the condition of receiving 4% of net sales as current technology fees (royalty)."

Commercial • Idiopathic Pulmonary Fibrosis • Pulmonary Arterial Hypertension

Naivek Completes Administration of Inflammatory Bowel Disease Treatment Drug 'NP-201' in Australian Clinical Phase 1b [Google translation] (Newstown) - "Naivec announced on the 20th that it has completed the 1b dosing of the Australian phase 1b/2a clinical trial of 'NP-201', an inflammatory bowel disease treatment. All doses up to the maximum dose of cohort 3 in the 1b clinical trial have been completed, and no serious adverse reactions have been reported to date....Naivec expects to receive the final results of the Phase 1b clinical trial for NP-201 in May. Separately from this global clinical trial, Naivec plans to apply for a Phase 2a clinical trial for NP-201 to the U.S. Food and Drug Administration (FDA). Based on the Australian clinical data, it is preparing to apply for FDA clinical trials and is currently pursuing a Type C meeting with the FDA to discuss clinical trial details."

P1 data • Trial status • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: NIBEC Co., Ltd. | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2027 ➔ May 2025 | Trial primary completion date: Dec 2025 ➔ Mar 2025

Enrollment open • Trial completion date • Trial primary completion date • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

A Study of NP-201 Acetate Injection in Healthy Adult Volunteers and in Patients With Mild-To-Moderate Active Ulcerative Colitis (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: NIBEC Co., Ltd.

New P1 trial • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Nyvec presents the world's first regenerative inflammatory bowel disease treatment at an international conference [Google translation] (Pharm News) - P=NA | N=32 | "Nyvec announced...that it will participate in the 'IBD INNOVATE Conference 2024' and announce the research and development results of 'NP-201', an inflammatory bowel disease treatment with a regenerative mechanism that it is developing....At this conference, Nyvec plans to disclose clinical and preclinical trial data for NP-201, an inflammatory bowel disease treatment with a peptide-based regenerative mechanism....As a result of the test, NP-201 showed no abnormalities in absorption, distribution, and excretion at high concentrations, and the half-life was also maintained for an appropriate period of time. Even in preclinical tests, NP-201 was confirmed to have excellent efficacy."

Clinical data • Preclinical • Immunology • Inflammatory Bowel Disease

Nyvec, world’s first regenerative inflammatory bowel disease treatment ’US FDA clinical trial Pre-IND’ [Google translation] (Pharm News) - "Nyvec successfully completed the Pre-IND process to proceed with phase 1b/2a clinical trials of its self-developed new drug 'NP-201' as an inflammatory bowel disease treatment at the U.S. Food and Drug Administration (FDA)....Nyvek plans to apply for an IND (Inclinical Investigational New Drug) for NP-201 in the second half of this year....'As early as this year or early next year at the latest. 'We will be able to enter clinical trials that include medication...'"

IND • New P1/2 trial • Immunology • Inflammatory Bowel Disease

[Feature stock] Nivec, strong with FDA approval of key implant material [Google translation] (BioTimes) - "In addition, the results of the global clinical trial of NIPEP-PF, a pulmonary fibrosis treatment that global pharmaceutical companies are interested in, are scheduled to be announced within the year, and various peptide-based pipelines and drug delivery platforms such as NIPEP-IBD, an inflammatory bowel disease treatment, are being researched and developed."

Clinical data • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases

Nivec, “Bio USA pays attention to global pharmaceutical companies’ peptide pipeline clinical trials” [Google translation] (Pharm News) - "Nivec, a company specializing in peptide fusion biotechnology, announced on the 15th that it had discussed partnerships with about 30 global pharmaceutical companies, including 'Pfizer', at 'Bio USA'....According to the company, during this BioUSA period, global pharmaceutical companies, including Pfizer, expressed great interest in the pipeline. paid attention to....The drug delivery platform technology was also discussed for technical cooperation with global pharmaceutical companies. In particular, the company is pursuing specific technical cooperation agreements, including concluding confidentiality and material transfer agreements, with global pharmaceutical companies in the field of pain and nervous system disease treatment....'NIPEP-PF', which is waiting for global phase 1 clinical results, shows tolerance and selective drug distribution in the interim results, and plans to sign confidentiality agreements with licensed pharmaceutical."

Licensing / partnership • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

[SEN] Nyvek participates in the JPM conference…“Announcement of interim clinical results for pulmonary fibrosis treatment” [Google translation] (Sedaily) - P1 | N=NA | Sponsor: Nibek | "JPMorgan Healthcare Conference...announce the interim results of the global clinical phase 1 of the pulmonary fibrosis treatment 'NP-201'. The conference will be held for 4 days from January 9th to 12th next year. NP-201, which is undergoing phase 1 clinical trials in Australia, completed high-dose administration up to 3 groups, and the company explained that no unusual side effects occurred....'Since NP-201, a pulmonary fibrosis treatment, has been proven effective in pulmonary arterial hypertension and good results are expected in phase 1 clinical trials, related discussions are expected to proceed.'"

P1 data • Idiopathic Pulmonary Fibrosis • Interstitial Lung Disease

Nyvec launches global clinical trials for pulmonary fibrosis treatment… What makes it different from existing treatments? [Google translation] (BioTimes) - "Nyvec...has started full-scale global clinical trials for 'NP-201', a treatment for lung fibrosis. The company started administering the first injectable drug to clinical patients in the Australian phase 1 clinical trial...The phase 1 clinical trial was conducted at the CMAX Clinical Trial Center (CMAX), a local clinical institution, by dividing 32 healthy adults aged 18 to 20 into 4 groups and administering a single subcutaneous injection of 'NP-201' for pharmacokinetic properties, safety, and tolerability. plan to evaluate."

Trial status • Idiopathic Pulmonary Fibrosis