OLP-1002 / Olipass - LARVOL DELTA

Sodium Channel Inhibitors in Clinical Development for Pain Management: A Focused Review. (PubMed, CNS Drugs) - "This review explores sodium channel inhibitors currently in clinical development, with a focus on suzetrigine (VX-548), the first US Food and Drug Administration (FDA)-approved Nav1.8 inhibitor for acute pain, as well as other investigational agents such as ralfinamide, OLP-1002, LTGO-33 and HBW-004285. Despite setbacks in early candidates owing to selectivity and tolerability issues, ongoing trials demonstrate renewed optimism for a new class of analgesics that may overcome the limitations of traditional pain therapies. We discuss key pharmacological challenges observed in earlier trials including functional redundancy, species differences, and on-target side effects, and outline how emerging strategies, such as structural biology-guided design, combination therapies, and precision medicine, are paving the way for safer, more effective, nonaddictive pain treatments."

Journal • Review • Addiction (Opioid and Alcohol) • Neuralgia • Pain • NAV1

Study of OLP-1002 Injections for Reducing Moderate to Severe Pain Due to Osteoarthritis in Hip and/or Knee Joint (clinicaltrials.gov) - P2 | N=134 | Completed | Sponsor: OliPass Corporation | Recruiting ➔ Completed | Phase classification: P2a ➔ P2 | Trial primary completion date: May 2023 ➔ Sep 2023

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

OliPass Discloses Painful but Hilarious Clinical Findings from a Phase 2a Trial in OA Patients with Nav1.7 Selective Inhibitor OLP-1002 (PRNewswire) - P2a | N=120 | NCT05216341 | Sponsor: OliPass Corporation | "OliPass Corporation...disclosed uncanny clinical findings from a multi-center Phase 2a trial with Nav1.7 selective OLP-1002 in osteoarthritis (OA) patients with moderate to severe pain in Australia with Novotech.... 1 mcg OLP-1002 turned out to be most effective, showing average pain reductions of 50 ~ 70% by WOMAC Pain and 60 ~ 80% by VAS over the period of 4 weeks. All the five patients on 1 mcg OLP-1002 effectively responded to the medication....An interim analysis was conducted for the first 30 patients (10 patients per group) to estimate due statistical power for efficacy. The interim analysis suggested that the study be properly powered for efficacy if evaluated in 60 to 90 patients. The study was extended to evaluate 59 additional patients."

P2a data • CNS Disorders • Osteoarthritis • Pain

“Safe for long-term use”… Acquired domestic patent for non-narcotic analgesic candidate [Google translation] (Nate) - "Olipass, an RNA therapeutic platform company, has acquired a domestic patent for 'OLP-1002', a non-narcotic analgesic that is currently undergoing phase 2a clinical trials for patients with chronic arthritis pain. According to OliPass on the 21st, this is the 11th domestic patent acquisition, following the United States, Japan, Australia, and China. Currently, material patent examination for OLP-1002 is underway in countries such as Europe, India, Brazil, and Canada."

Patent • CNS Disorders • Osteoarthritis • Pain

Olipass acquires patent for non-narcotic painkiller 'OLP-1002' [Google translation] (HIT News) - "Olipass...has acquired a Chinese patent for 'OLP-1002 (development code name)', a non-narcotic analgesic that is undergoing phase 2a clinical evaluation for patients with chronic arthritis pain. It was announced on the 25th. This Chinese patent acquisition marks the 10th, including those in the United States, Japan, and Australia....Meanwhile, according to the company, the phase 2a placebo-controlled, double-blind clinical trial for OLP-1002 was completed on the 94th patient on the 7th after the first patient received the medication at the end of September last year. Currently, compilation of clinical results is in progress."

Patent • Trial completion • CNS Disorders • Osteoarthritis • Pain

OliPass raises funds worth 10 billion won… “Push for L/O after clinical trials are completed” [Google translation] (Sedaily) - "...Olipass announced a paid-in capital increase worth 5 billion won and a CB issuance worth 5 billion won on the 4th. The purpose of the capital increase is to raise operating funds, which are expected to be mainly used to complete clinical trials for 'OLP-1002', a new non-narcotic painkiller that Olipass is pursuing. For both paid-in capital increase and CB, the conversion price (2,085 won) and the minimum adjustment price were set at 1,460 won."

Financing • CNS Disorders • Osteoarthritis • Pain

Olipass, pain reliever 'OLP-1002' completed phase 2 clinical trial in Australia [Google translation] (HIT News) - "OliPass...announced on the 28th that it had completed all administration of phase 2a clinical trials in Australia for the new non-narcotic analgesic drug 'OLP-1002 (development code name)'. This Phase 2a Phase 2 evaluation is conducted on patients with chronic arthritis pain. After a single injection of 1 μg or 2 μg of OLP-1002 or a placebo, changes in pain were followed over 6 weeks. The evaluation of the last dosed patient is expected to be completed around September 10th." "

Trial status • CNS Disorders • Osteoarthritis • Pain

Phase 2a clinical trial for Olipass painkiller and development of Lou Gehrig’s treatment “on cruise” [Google translation] (Health in News) - "Since the last interim evaluation, more than 20 patients have been additionally administered, and for many patients, the 6-week analgesic efficacy evaluation has been completed, the company said."

Enrollment status • CNS Disorders • Osteoarthritis • Pain

Olipass, analgesic 'OLP-1002' efficacy confirmed in phase 2a clinical trial [Google translation] (Pharm News) - P2a | N=120 | NCT05216341 | Sponsor: OliPass Corporation | "Olipass Co., Ltd...conducted interim statistics on the first 30 patients who were evaluated in the Australian phase 2a 'placebo-controlled double-blind' trial for the new non-narcotic analgesic 'OLP-1002'. Interim analysis is being conducted in detail, and it was revealed on the 6th that the WOMAC_Pain score, the primary pain index, decreased statistically significantly (p-value 0.05 or less) in the 2 microgram (mcg) administration group....Since the interim statistical evaluation is carried out by reflecting various perspectives and variables, it is expected that it will take some time to complete the statistical analysis of all indicators. When the clinical evaluation is completed, the p-value between the 2 mcg OLP-1002 administration group and the placebo group is expected to stably reach 0.01 or less, the company said."

P2a data • CNS Disorders • Osteoarthritis • Pain

Olipass acquires Japanese patent for non-narcotic analgesic 'OLP-1002' [Google translation] (Hankyung) - "OliPass announced...that it had obtained a Japanese patent for the non-narcotic pain reliever 'OLP-1002' and its derivatives. The patent name is 'SCN9A Antisense Pain killer'. This patent acquisition is said to be the eighth following the United States, Singapore, and Australia. Olipass has applied for material patents in major countries around the world and is undergoing examination."

Patent • CNS Disorders • Osteoarthritis • Pain

Olipass, 'Nav1.7 inhibitor' pain phase 2a “interim results disclosed” [Google translation] (Biospectator) - P2a | N=120 | NCT05216341 | Sponsor: OliPass Corporation | "RNA platform company Olipass announced on the 30th the results of its own interim analysis of the first 30 patients evaluated in the Australian phase 2a placebo-controlled double-blind trial of the non-narcotic analgesic candidate 'OLP-1002'. Although the trend for analgesic efficacy was confirmed, it was a result that did not secure statistical significance in small clinical trials....According to the results of OLP-1002's own analysis, a trend toward higher analgesic efficacy was observed in the group administered with 2μg of OLP-1002 than the 1μg or placebo group, and the efficacy reached its maximum at 5 to 6 weeks after administration in the 2μg-administered group....Olipass plans to notify the top-line results of this interim evaluation separately after the end of February when the analysis is completed."

P2a data • CNS Disorders • Osteoarthritis • Pain

Olipass, non-narcotic analgesic Australia phase 2a phase 2 evaluation update [Google traslation] (BioTimes) - P2 | N=120 | NCT05216341 | Sponsor: OliPass Corporation | "In this second-phase evaluation, after administering 1 microgram OLP-1002, 2 microgram OLP-1002, or a placebo once to patients with arthritis pain, the analgesic efficacy of each patient was followed in a placebo-controlled, double-blind manner over 6 weeks. Since the first patient was administered at the end of September, a total of 31 patients have been administered until November 25th. Of the 31 patients who received medication, 2 patients completed a 6-week pain follow-up evaluation, and most patients had a pain follow-up evaluation of 2 weeks or longer...When analyzed based on the pain follow-up results for the first two weeks after administration obtained so far, a significant number of patients had similar pain reductions as those of patients who received '1 microgram OLP-1002' in the last stage 1 open label evaluation completed. A pattern is being observed..."

Enrollment status • P2 data • CNS Disorders • Osteoarthritis • Pain

Olipass “Non-narcotic analgesic OLP-1002, phase 2a phase 2 evaluation in Australia” [Google translation] (Health Korea News) - "According to the company, this clinical trial is proceeding smoothly, with 23 patients receiving the drug since the first patient was administered at the end of September, and the efficacy pattern observed in the phase 1 open-label evaluation of phase 2a clinical trial was observed."

Trial status • CNS Disorders • Osteoarthritis • Pain

Study of OLP-1002 Injections for Reducing Moderate to Severe Pain Due to Osteoarthritis in Hip and/or Knee Joint (clinicaltrials.gov) - P2a | N=120 | Recruiting | Sponsor: OliPass Corporation | N=30 ➔ 120

Enrollment change • Immunology • Osteoarthritis • Pain • Rheumatology

Olipass Announces 'OLP-1002' Phase 2a Phase 1 Results at the World Pain Society Conference [Google translation] (Hankyung) - P2 | N=30 | NCT05216341 | Sponsor: OliPass Corporation | "Olipass announced on the 26th that it had presented the main non-clinical results of the non-narcotic analgesic 'OLP-1002' and the results of the Australian Phase 2a clinical trial as a poster at the '2022 World Society for Pain Management'....The presentation was focused on the analgesic efficacy observed in Australia's Phase 2a Phase 1 (open label), which has recently been discontinued. By analyzing the animal analgesic efficacy results and clinical efficacy results of OLP-1002, they said that they focused on explaining the appropriate clinical dose of OLP-1002 identified in Phase 2a Phase 1. In rodents, Nav1.7 inhibition was found to play a more important role in pain suppression in the central nervous system than in the peripheral nerves. On the other hand, based on the results of Phase 2a Phase 1, it was concluded that in humans, strong analgesic efficacy could be secured only by inhibition of Nav1.7 in peripheral nerves."

P2 data • Preclinical • CNS Disorders • Osteoarthritis • Pain

Olipass Announces 'Australian Phase 2a Clinical Phase 1 Results' of Non-narcotic Pain Relief at the World Pain Society Conference [Google translation] (Pharm News) - "Olipass Co., Ltd...announced the main preclinical efficacy results of the non-narcotic analgesic 'OLP-1002' and the Australian Phase 2a Phase 1 open-label clinical trial at the 2022 World Congress. on Pain) announced on the 30th that the poster will be released....Phase 2 evaluation is scheduled to begin in September."

P2a data • CNS Disorders • Osteoarthritis • Pain

Olipass acquires approval for non-narcotic analgesic analgesic in Australia, Phase 2a Phase 2 clinical trial [Google translation] (eDaily) - "Olipass...announced on the 10th that the Australian Ethics Committee (HREC) has approved the Phase 2 clinical trial plan for the Australian Phase 2a trial of the non-narcotic analgesic new drug 'OLP-1002'."

New P2a trial • CNS Disorders • Osteoarthritis • Pain

Olipass, non-narcotic analgesic 'OLP-1002' entered Australia Phase 2a Phase 2 early [Google translation] (Pharm News) - "Olipass...submitted a clinical trial to the Ethics Committee (HREC) for the evaluation of the 'placebo-controlled double-blind' phase 2 clinical trial in Australia for the non-narcotic analgesic new drug 'OLP-1002'....'The Pre-IND meeting with the US FDA, which was conducted to explore the US Phase 2a clinical trial, has been successfully completed, and the data has been gradually reinforced in consideration of the FDA's opinions presented at the Pre-IND meeting, causing disruptions in the US Phase 2 clinical IND approval. 'The US IND submission is planned before and after the end of October, and the first clinical administration is expected early next year...'"

FDA event • IND • New P2 trial • New P2a trial • Trial initiation date • CNS Disorders • Osteoarthritis • Pain

Olipass, interim results of non-narcotic analgesic clinical trial 2a …"Keeping pain relief at 65-85% for 2 weeks" [Google translation] (Investing.com) - P2a | N=30 | NCT05216341 | Sponsor: OliPass Corporation | "Olipass...announced the interim results of the Australian phase 2a clinical trial of OLP-1002, a non-narcotic analgesic, to domestic and foreign investors. According to the interim results of the OLP-1002 phase 2a clinical trial announced this time, in the case of the 1㎍ (microgram) administration group specialized for peripheral innervation, the analgesic effect was very strong, with an average of 65% to 85% of 5 patients for 2 weeks after administration. appeared to be maintained....A phase 2, placebo-controlled, double-blind evaluation of a total of 30 to 60 arthritis patients is scheduled to begin in September."

New P2 trial • P2a data • CNS Disorders • Osteoarthritis • Pain

OliPass Announces Commencement of Dosing in Phase 2a Trial for Pain Killer OLP-1002 (PRNewswire) - "OliPass Corporation...announced that the dosing of pain killer OLP-1002 commenced for a Phase 2a trial in osteoarthritis patients with pain...The Phase 2a trial is of a two stage adaptive design. The first stage is an open label study to identify an optimum dose range of the efficacy profile, in which patients receive a single subcutaneous injection of 1 ~ 80 mcg (microgram) OLP-1002. The second stage shall be a placebo-controlled double blind study to evaluate two doses of OLP-1002 selected based on the findings from the first stage."

Trial status • CNS Disorders • Osteoarthritis • Pain

A Study of OLP-1002 Subcutaneous Injections for Reducing Moderate to Severe Pain Due to Osteoarthritis in a Hip and/or Knee Joint (clinicaltrials.gov) - P2a | N=30 | Recruiting | Sponsor: OliPass Corporation

New P2a trial • Immunology • Osteoarthritis • Pain • Rheumatology

"Safe non-narcotic pain reliever, technology will be exported this year" [Google translation] (Sedaily) - "Non-narcotic analgesic 'OLP-1002' plans to license out (export technology) with a global pharmaceutical company that is currently under negotiation after the end of phase 2 administration in the first quarter of this year.”"

Licensing / partnership • CNS Disorders • Osteoarthritis • Pain

Olipass acquires Japanese patent for 'SCN9A antisense' pain reliever [Google translation] (Hankyung) - "Olipass...said 13 that it has obtained the patent for the material 'OliPass PNA' artificial gene to inhibit the 'SCN9A' activity of the gene to reduce the pain from the Patent Office in Japan. This material patent has been applied for in major countries around the world and is currently under examination."

Patent • CNS Disorders • Osteoarthritis • Pain

Olipass non-narcotic analgesic analgesic progresses in Australia [Google translation] (businesspost.co.kr) - "According to Olipass on the 5th, it is preparing to start the Australian phase 2a clinical trial of 'OLP-1002', a non-narcotic analgesic candidate, within December. CEO Jung has set up a plan to apply for a follow-up clinical trial to the US Food and Drug Administration (FDA) with the positive results of OLP-1002's phase 2a clinical trial in Australia within 2022."

New P2a trial • New trial • CNS Disorders • Osteoarthritis • Pain

SCN9A Antisense Pain Killer OLP-1002 Moves into Phase 2a Stage (PRNewswire) - “OliPass Corporation…announced to initiate a Phase 2a trial for SCN9A antisense pain killer OLP-1002 in Australia. In the Phase 2a trial of a two stage adaptive design in OA patients with pain, OLP-1002 shall be evaluated for analgesic efficacy, safety and therapeutic duration to confirm the target drug profiles as a first-line therapy for chronic pain. Long therapeutic duration is desired for good patient compliance, since OLP-1002 is currently developed for administration by subcutaneous injection….OliPass is planning additional Phase 2a trial in the US for chemotherapy-induced neuropathic pain (CINP). CINP may be taken as a good and realistic model system for neuropathic pain considering the mode of action of OLP-1002.”

New P2a trial • CNS Disorders • Pain