KM023 / Kainos Medicine, Jiangsu Aidea Pharma - LARVOL DELTA

Study of KM-023 in Healthy Volunteers and Patients With Olmsted Syndrome. (clinicaltrials.gov) - P1 | N=64 | Recruiting | Sponsor: Kamari Pharma Ltd

New P1 trial

TRPV3 novel inhibitor KM-023 as a potential oral treatment for keratodermas (SID 2025) - "The results suggest that KM-023 can be potentially used to treat OS, PC and other Keratodermas. A Phase 1 study in healthy volunteers and OS patients is planned to be initiated shortly."

Dermatology • Inflammation • Pruritus • LORICRIN • TRPV3

Phase II study evaluating the safety and efficacy of neratinib and trastuzumab biosimilar in patients with HER2 mutated advanced solid tumors: KCSG AL20-17/KM23 trial. (PubMed, Cancer Commun (Lond)) - No abstract available

Journal • P2 data • Oncology • Solid Tumor • HER-2

Predicting drug‐drug interactions between ainuovirine and rifampicin plus isoniazid using PBPK modelling (HIV-Glasgow 2024) - "Background: Ainuovirine (ACC007) is a next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) primarily metabolized by CYP2C19... The developed PBPK model characterized the opposite effect-mediated DDIs between RFP and INH on metabolisms of ANV, accurately predicting a narrowed therapeutic window when ANV 150 mg daily was co-administered with RFP plus INH. A change in ANV dosing regimen from 150 to 225 mg was predicted to mitigate the effect of the DDIs on the Cmax and Ctrough of ANV, maintaining plasma concentration levels above the therapeutic threshold but well below the safety margin."

Human Immunodeficiency Virus • Infectious Disease • Respiratory Diseases • Tuberculosis • CYP2C19

Effect of fluconazole on the pharmacokinetics of ainuovirine in healthy adults (HIV-Glasgow 2024) - "Background: Ainuovirine (ACC007) is a next-generation non-nucleoside reverse transcriptase inhibitor (NNRTI) for combinational therapy for people living with HIV, which is primarily metabolized by CYP2C19. Co-administration of ainuovirine with fluconazole significantly increased ainuovirine systemic exposure, whereas ainuovirine did not appear to affect fluconazole exposure. Therefore, it is recommended that the ainuovirine dose be halved (i.e. 75 mg) when co-administered with strong CYP2C19 inhibitors, including fluconazole."

Clinical • PK/PD data • Human Immunodeficiency Virus • Infectious Disease • CYP2C19

The function of the cytoplasmic dynein light chain PTKM23 in the transport of PTSMAD2 during spermatogenesis in Portunus trituberculatus. (PubMed, Biol Reprod) - "KM23 belongs to the dynein light chain family...These results indicate that PTKM23 is involved in the assembly of cytoplasmic dynein and microtubules during spermatogenesis and that PTKM23 mediates the participation of cytoplasmic dynein in the transport of PTSMAD2 during spermatogenesis. This study provides a theoretical molecular biological basis for the breeding of P. trituberculatus."

Journal • SMAD2 • TP53

Hydroxy(phenyl)pyruvic acid reductase in Actaea racemosa L.: a putative enzyme in cimicifugic and fukinolic acid biosynthesis. (PubMed, Planta) - "NADPH is the preferred cosubstrate (Km 23 ± 4 µM). Several substrates are accepted by ArH(P)PR with β-hydroxypyruvic acid (Km 0.26 ± 0.12 mM) followed by 4-hydroxyphenylpyruvic acid (Km 1.13 ± 0.12 mM) as the best ones. Thus, ArH(P)PR has properties of β-hydroxypyruvic acid reductase (involved in photorespiration) as well as hydroxyphenylpyruvic acid reductase (possibly involved in benzyltartaric acid formation)."

Journal

No Meaningful Drug-Drug Interactions Are Associated with the Coadministration of ACC007, Lamivudine, and Tenofovir Disoproxil Fumarate. (PubMed, Antimicrob Agents Chemother) - "ACC007 is a new-generation nonnucleoside reverse transcriptase inhibitor (NNRTI) with favorable pharmacokinetic and safety profiles. ACC007 combined with 3TC-TDF was generally well tolerated during daily dosing for 17 days with no serious adverse events. Overall, ACC007 and 3TC-TDF had no significant or meaningful interactions and a favorable safety profile, which supports the use of the combination regimen."

Journal • Human Immunodeficiency Virus • Infectious Disease

Kainos Medicine shares rally on partnership with Jiangsu Aidi for global sale of AIDS therapy (Pulse by Maeil Business News Korea) - "...Kainos Medicine Inc....announced that it signed a memorandum of understanding with its Chinese partner Jiangsu Aidi Pharmaceutical for joint commercial development of Kainos Medicine’s AIDS therapy (KM-023) in global markets....Jiangsu Aidi has co-developed ACC007, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), based the KM-023 technology from Kainos Medicine....The two companies agreed to set up a joint venture to sell KM-023 in global markets except Korea and China, which is pending trial results and regulatory approval."

Licensing / partnership • Human Immunodeficiency Virus

The new anti-AIDS drug developed by Yangqi has entered the countdown to the market and the future market has great prospects [Google translation] (Yznews) - "The reporter learned yesterday that the single-chip anti-HIV chemical class 1 new drug ACC007...has successfully completed the food and drug review and inspection of the State Drug Administration On-site inspection of drug registration in the center. This means that ACC007 monolithic is expected to be approved for new drug marketing and enter the 'countdown' stage of listing."

Non-US regulatory • Human Immunodeficiency Virus

Kino’s Med export AIDS treatment Chinese scholar “Expectation for marketability“ [Google translation] (The Korea Economic Daily) - "Kynosmed...announced on the 28th that the Chinese top authority evaluated 'the first oral treatment developed in China, and marketability is expected' for AIDS treatments developed by Chinese partners. Prof. Wu Hao said this while presenting the results of Phase 3 clinical trials of Jangsu ID's AIDS treatment (ACC007) at the 'China Biomed Innovation and Investment Conference' (CBIIC) held in Suzhou, China the day before."

Non-US regulatory • P3 data • Human Immunodeficiency Virus

Kinosmed AIDS treatment approved for phase 3 clinical trial in single-complex tablets [Google translation] (Sedaily) - "Kynosmed...Announced on the 3rd that a Chinese partner recently received approval from the Chinese National Drug Administration and Administration for Phase 3 clinical trials of the AIDS treatment single combination tablet (ACC008)....Jangsu ID recently completed phase 3 clinical trials of ACC007 and submitted an application for registration of a drug produced in China. ACC007 was clinically conducted in a way that was prescribed with tenofovir and lamivudine."

Non-US regulatory • Human Immunodeficiency Virus

Aidi Pharmaceuticals: Class 1 new drugs under development in the field of anti-AIDS are planned to be included in the priority review process [Google translation] (Sina Corp) - "...Aidi Pharmaceuticals (688488) announced on the evening of August 7 that the company's new class 1 drug ACC007 in the field of anti-AIDS was recently included in the list of proposed priority review varieties by the National Center for Drug Evaluation. The publicity period is 5 day. ACC007 is a non-nucleoside reverse transcriptase inhibitor with a new structure, and is the company's first class 1 new anti-AIDS drug."

Non-US regulatory • Human Immunodeficiency Virus

Aidi [sic] Pharmaceuticals’ first application for the registration of a new anti-AIDS class 1 drug is accepted and a patent license fee will be paid every year [Google translation] (Sina Corp) - "Aidi [sic] Pharmaceuticals...first anti-AIDS category 1 new drug registration application is accepted, and a patent license fee is required to be paid at 2% of the total sales each year....Received the 'Notice of Acceptance' issued by the State Food and Drug Administration regarding the registration application for the domestic production of ACC007...will be issued with a drug approval certificate and can be put into production and sales after approval....ACC007 has now completed phase III clinical trials with good results and in line with expectations, and strives to be approved for listing by the end of 2020. The announcement on the evening of July 23 also showed that the dosage form of ACC007 was tablet, and the specification was 75mg/tablet."

Non-US regulatory • Patent • Human Immunodeficiency Virus