INE963 / Novartis - LARVOL DELTA

The non-artemisinin antimalarial drugs under development: a review. (PubMed, Clin Microbiol Infect) - "Although attrition remains a possibility, several promising candidate drugs with novel modes of action are advancing through clinical development. Many are expected to become available for treating uncomplicated and severe malaria within the next decade. These new antimalarials could significantly enhance malaria treatment, reduce resistance, and support global health effort toward malaria control, elimination, and, potentially, eradication."

Journal • Review • Infectious Disease • Malaria

Differential ex vivo susceptibility of Plasmodium malariae and Plasmodium falciparum clinical isolates from Ghana and Mali to current and lead discovery candidate antimalarial drugs. (PubMed, Microbiol Spectr) - "In Ghana, the susceptibility of the two species to most of the current antimalarial drugs was comparable, except for artemether, sulfadoxine, and atovaquone, for which the drugs were less potent against P. malariae than P. falciparum (7.12 vs 2.15 nM, 25.72 vs 7.86 nM, and 10.38 vs 2.51 nM, respectively). In Mali, quinine was significantly more potent against P. malariae than P. falciparum (18.35 and 26.84 nM), and tafenoquine was less potent against P. malariae than P. falciparum (5.50 and 2.85 nM). Among the candidate drugs, except INE963, whose inhibitory potency was comparable between both species, the other compounds significantly inhibited P. malariae more than P. falciparum...However, in Mali, chloroquine resistance appeared to have affected the suitability of quinine-based compounds for non-falciparum malaria treatment. Therefore, additional studies are required to establish the efficacy of artemether-lumefantrine for the treatment of P. malariae..."

Journal • Preclinical • Infectious Disease • Malaria

PLATINUM: Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria (clinicaltrials.gov) - P2 | N=327 | Recruiting | Sponsor: Novartis Pharmaceuticals | N=207 ➔ 327 | Trial completion date: Oct 2025 ➔ May 2026

Enrollment change • Trial completion date • Infectious Disease • Malaria

PLATINUM: Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria (clinicaltrials.gov) - P2 | N=207 | Recruiting | Sponsor: Novartis Pharmaceuticals | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Monotherapy • Infectious Disease • Malaria

Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Terminated | Sponsor: Novartis Pharmaceuticals | Completed ➔ Terminated; Sponsor's decision.

Trial termination

Recent developments in antimalarial drug discovery. (PubMed, Bioorg Med Chem) - "Methods to fight malaria are being diversified, including the use of mosquito nets, the target candidate profiles (TCPs) and target product profiles (TPPs) of medicine for malarial venture (MMV) strategy, the search for newer and potent drugs that could reverse chloroquine resistance, and the use of adjuvants such as rosiglitazone and sevuparin. Although these adjuvants have no antiplasmodial activity, they can help to alleviate the effects which result from plasmodium invasion such as cytoadherence. The list of new antimalarial drugs under development is long, including the out of ordinary new drugs MMV048, CDRI-97/78 and INE963 from South Africa, India and Novartis, respectively."

Journal • Review • Infectious Disease • Malaria

Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Completed | Sponsor: Novartis Pharmaceuticals | Terminated ➔ Completed

Trial completion

PLATINUM: Platform Study to Evaluate the Efficacy and Safety of Anti-malarial Agents in Patients With Uncomplicated Plasmodium Falciparum Malaria (clinicaltrials.gov) - P2 | N=180 | Not yet recruiting | Sponsor: Novartis Pharmaceuticals

Combination therapy • Monotherapy • New P2 trial • Infectious Disease • Malaria

Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - P1 | N=64 | Terminated | Sponsor: Novartis Pharmaceuticals | Trial completion date: Mar 2023 ➔ Nov 2022 | Recruiting ➔ Terminated; Sponsor's decision

Trial completion date • Trial termination

Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Novartis Pharmaceuticals | Trial completion date: Nov 2022 ➔ Mar 2023

Trial completion date

Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Novartis Pharmaceuticals | N=53 ➔ 76

Enrollment change

Discovery and Preclinical Pharmacology of INE963, a Potent and Fast-Acting Blood-Stage Antimalarial with a High Barrier to Resistance and Potential for Single-Dose Cures in Uncomplicated Malaria. (PubMed, J Med Chem) - "These properties suggest the significant potential for INE963 (1) to provide a curative therapy for uncomplicated malaria with short dosing regimens. For these reasons, INE963 (1) was progressed through GLP toxicology studies and is now undergoing Ph1 clinical trials."

Journal • Preclinical • Infectious Disease • Malaria

Discovery of clinical candidate INE963: A potent and fast-acting blood-stage antimalarial with a high barrier to resistance and potential for single-dose cure in uncomplicated malaria. (ACS-Sp 2022) - "Taken together, these properties craft a great potential for INE963 to provide a curative therapy for uncomplicated malaria with short dosing regimens. For these reasons, INE963 was progressed through GLP toxicology studies and is now undergoing Ph1 clinical trials."

Clinical • Infectious Disease • Malaria

Study of Safety, Tolerability, and Pharmacokinetics of INE963 in Healthy Participants (clinicaltrials.gov) - P1; N=53; Recruiting; Sponsor: Novartis Pharmaceuticals; Trial completion date: Nov 2021 ➔ Jun 2022; Trial primary completion date: Nov 2021 ➔ Jun 2022

Clinical • Trial completion date • Trial primary completion date