SMUP-IA-01 / Medipost - LARVOL DELTA

Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Subjects Receiving SMUP-IA-01 or Active Control (clinicaltrials.gov) - P2 | N=84 | Active, not recruiting | Sponsor: Medipost Co Ltd. | Trial completion date: Nov 2026 ➔ Nov 2027 | Trial primary completion date: Mar 2026 ➔ Mar 2027

Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology

Clinical Trial to Evaluate Efficacy and Safety of SMUP-IA-01 in Patients With Knee Osteoarthritis (clinicaltrials.gov) - P2 | N=94 | Completed | Sponsor: Medipost Co Ltd. | Recruiting ➔ Completed

Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology

Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Patients Receiving SMUP-IA-01 or Active Control (clinicaltrials.gov) - P2 | N=84 | Active, not recruiting | Sponsor: Medipost Co Ltd.

New P2 trial • Immunology • Osteoarthritis • Pain • Rheumatology

Medipost, Injectable Knee Osteoarthritis Treatment 'SMUP-IA-01', Long-term Efficacy and Safety Confirmed [Google translation] (Hankyung) - P1 | N=12 | NCT04037345 | Sponsor: Medipost Co Ltd. | "Medipost...has confirmed that the long-term efficacy and safety of its injectable knee osteoarthritis stem cell treatment 'SMUP-IA-01' continues for up to 4 years after administration....The data analysis results once again confirmed its long-term efficacy and safety. All of the efficacy indices, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), 100-mm Visual Analogue Scale (VAS), and International Knee Documentation Committee (IKDC) subjective knee assessment, showed improved efficacy compared to before administration even after 4 years after administration."

P1 data • CNS Disorders • Osteoarthritis • Pain

Medipost Announces Phase 2 Clinical Results for SMUP-IA-01, Injectable Knee Osteoarthritis Treatment [Google translation] (Hankyung) - P2 | N=93 | NCT05182034 | Sponsor: Medipost Co Ltd. | "Medipost (CEO Won-il Oh) announced the results of the domestic phase 2 clinical trial of SMUP-IA-01, an injectable knee osteoarthritis treatment, on the 10th....As a result of the clinical trial, it was confirmed that SMUP-IA-01 administration was safe as no immune response or serious adverse drug reaction occurred, and the efficacy evaluation index, WOMAC (pain for osteoarthritis, pain, The SMUP-IA-01 treatment group also showed a statistically significant improvement in symptoms compared to the baseline in the total score change result (an index scored in three areas such as stiffness and physical function) (p<0.0001). However, it was not observed that the SMUP-IA-01 administration group was superior to the control group, the sodium hyaluronate injection group."

P2 data • CNS Disorders • Osteoarthritis • Pain

Medipost recorded 54.9 billion won in sales last year [Google translation] (Medical News) - "Last year, the company recorded an operating loss of 5.24 billion won, an increase of 117% compared to the previous year, due to an increase in R&D costs for injection-type knee osteoarthritis treatment SMUP-IA-01 and advance investment in GMP production facilities."

Commercial • CNS Disorders • Osteoarthritis • Pain

Medipost completes domestic phase 2 administration of injection-type knee osteoarthritis treatment [Google translation] (Hankyung) - "Medipost announced on the 12th that it has finished administering the injection-type knee osteoarthritis treatment (SMUP-IA-01) to patients in phase 2 clinical trials in Korea....The drug was administered once divided into SMUP-IA-01 low-dose and medium-dose, and an active control group. The safety and exploratory efficacy will be evaluated through an observation period of one year after administration, and the optimal dose for phase 3 clinical trial will be confirmed. SMUP-IA-01 confirmed the efficacy and safety of clinical symptoms such as knee pain and improvement of knee function after one administration as a result of domestic phase 1 results. As a result of a meeting with the US Food and Drug Administration (FDA), it was answered that it was possible to skip phase 1 and proceed with phase 2 in recognition of domestic clinical data. We plan to promote the second phase of the US."

Trial status • CNS Disorders • Osteoarthritis • Pain

Clinical Trial to Evaluate Efficacy and Safety of SMUP-IA-01 in Patients With Knee Osteoarthritis (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Medipost Co Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Osteoarthritis • Pain • Rheumatology • MMP3

Medipost secured investment, spurs entry into US clinical and CGT markets for Cartistem [Google translation] (Newsway) - "According to the industry on the 14th, Medipost attracted a total of 140 billion won in third-party allocation-type private equity funds in March....In addition, CEO Yang plans to use the investment in US clinical trials for knee osteoarthritis treatment 'Cartistem' and injectable osteoarthritis treatment 'SMUP-IA-01' to speed up its entry into the US osteoarthritis treatment market."

Financing • CNS Disorders • Osteoarthritis • Pain

Medipost begins administration of knee osteoarthritis drug in P2 trial (Korea Biomedical Review) - "Medipost said that it started administering SMUP-IA-01, an injection type knee osteoarthritis treatment, in a phase 2 trial in Korea....The company will conduct the trial at five medical institutions -- SNUH, Seoul National University Bundang Hospital, Severance Hospital, Asan Medical Center, and Korea University Anam Hospital – and administer the treatment to 90 knee osteoarthritis patients who have a Kellgren-Lawrence grading scale of 2-3."

Trial status • CNS Disorders • Immunology • Osteoarthritis • Pain

Clinical Trial to Evaluate Efficacy and Safety of SMUP-IA-01 in Patients With Knee Osteoarthritis (clinicaltrials.gov) - P2; N=90; Not yet recruiting; Sponsor: Medipost Co Ltd.

Clinical • New P2 trial • Immunology • Osteoarthritis • Pain • Rheumatology • MMP3 • MRI

Medipost enters domestic phase 2 clinical trial for knee osteoarthritis treatment SMUP-IA-01 [Google translation] (eDaily) - "Medipost announced on the 22nd that it has entered the domestic phase 2 clinical trial of 'SMUP-IA-01', an injection-type osteoarthritis treatment for the knee, developed in-house....This domestic phase 2 clinical trial for SMUP-IA-01 will be conducted at Seoul National University Hospital and Sinchon Severance Hospital, targeting a total of 90 patients with mild and moderate knee osteoarthritis. After dividing the patients into three groups of 30 patients, including the low-dose administration group, the medium-dose administration group, and the active control group, SMUP-IA-01 is injected once into the knee joint space and administered. After that, patients in each group will be observed for one year to evaluate the safety and exploratory efficacy of the drug, and the optimal dose for phase 3 clinical trial will also be confirmed."

Trial status • CNS Disorders • Osteoarthritis • Pain

Medipost strengthens its position in cord blood and taps into the global market for knee osteoarthritis 'speed' [Google translation] (Newdaily) - "The fact that the next-generation injection-type knee osteoarthritis treatment 'SMUP-IA-01' started a phase 2 clinical trial in Korea is also considered a factor in its resilience....'We plan to hold a Pre-IND meeting and promote clinical planning and technology transfer in the US.'"

FDA event • Trial status • CNS Disorders • Osteoarthritis • Pain

Medipost Approval of Korean Phase 2 Clinical Trial for Knee Osteoarthritis Treatment SMUP-IA-01 [Google translation] (Health Korea News) - “Medipost announced on the 27th that the domestic phase 2 clinical trial plan for SMUP-IA-01, a next-generation injectable knee osteoarthritis treatment, submitted to the Ministry of Food and Drug Safety in July was approved….In this domestic phase 2 clinical trial, SMUP-IA-01 was administered in a single injection into the knee joint cavity for a total of 90 patients with knee osteoarthritis of mild and moderate severity (K&L grades 2-3), and after a one-year observation period…We plan to confirm the optimal dose for phase 3 clinical trials. Clinical trials will be conducted at three institutions: Seoul National University Hospital, Sinchon Severance Hospital, and Seoul National University Bundang Hospital.”

New P2 trial • CNS Disorders • Osteoarthritis • Pain

Medipost's clinical trial approved to evaluate efficacy of knee osteoarthritis treatment (Aju Business Daily) - P1, N=12; NCT04037345; Sponsor: Medipost Co Ltd.; "Medipost, a South Korean biotech firm know for stem cell-based treatment, has applied for state approval to go ahead with phase 2 clinical trials to evaluate the safety and efficacy of its next-generation intra-articular Injectable treatment and prevention of knee osteoarthritis, code-named 'SMUP-IA-01'...Based on safety and validity data confirmed through clinical trials in South Korea, Medipost would send a pre-IND (investigational new drug) application to the U.S. Food and Drug Administration (FDA) in the fourth quarter of this year....In results of phase 1 clinical trials...Medipost said SMUP-IA-01 showed excellent safety and improved knee pain and joint function after six months of evaluation."

FDA event • New P2 trial • P1 data • CNS Disorders • Osteoarthritis • Pain

Evaluate Safety and Explore Efficacy of SMUP-IA-01 in Patients With Knee Osteoarthritis (clinicaltrials.gov) - P1; N=12; Completed; Sponsor: Medipost Co Ltd.; Recruiting ➔ Completed

Clinical • Trial completion • Immunology • Osteoarthritis • Pain • Rheumatology • MRI

Medipost, 3Q sales of 11.8 billion won... 6.3% ↑ [Google translation] (Maekyung Media Group) - "Katistem's application for phase 3 clinical trials in Japan and the completion of phase 1 clinical trials in Korea for injection-type knee osteoarthritis treatment SMUP-IA-01 will be promoted as planned by this year, and next year SMUP-IA-01 will be promoted promptly."

Trial status • CNS Disorders • Osteoarthritis • Pain

’Enforcement of the Science and Technology Act, interest in Medipost·Antrogen·Tegoscience’ [Google translation] (The Korea Economic Daily) - "Medipost is a stem cell therapy company. It is expected to complete phase 1 clinical trials in Korea for the injection-type knee arthritis treatment 'SMUP-IA-01' within this year and announce the results in the first half of next year."

P1 data • Trial completion date • Osteoarthritis • Pain

3: Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Medipost Co Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • CNS Disorders • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology • MRI

3: Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Medipost Co Ltd.

Clinical • New P1 trial

[Interview] Medipost to unlock potential in regenerative medicine (KoreaTimes) - "In September, Medipost received the Ministry of Food and Drug Safety's approval for a phase 1 trial of SMUP-IA-01, and has been testing the drug with Seoul National University, finishing the first round of injections, Oct. 14....Medipost plans to roll out its existing Cartistem treatment in Japan. The company applied for phase 2 trials of the drug to Japan's Pharmaceuticals and Medical Devices Agency in November and expects to see it granted this week. In the U.S., it has finished phase 1/2a trials....It surpassed the 10 billion won mark in yearly sales in 2017 and more than 1,100 vials were sold in the first quarter of this year."

Japanese regulatory • Sales • Trial completion • Trial status