Jerusalem, Israel, December 10, 2023

  • Indication of neurodegeneration slow down following IPL344 treatment

Immunity Pharma, a clinical-stage neurology-focused biopharmaceutical company, today updated on biomarker data from its Phase 2a study with IPL344 in ALS. In a poster presented at the 34th international symposium on ALS and motor neuron disease (MND), December 6-8, 2023, in Basel, Switzerland, the company reported an observed numerical reduction in plasma neurofilament NfL concentrations following IPL344 treatment. The poster was titled ‘Neurofilament light chain level reduction in plasma of ALS patients following IPL344 treatment in phase 1/2a clinical trial (NCT03652805, NCT03755167)’.

Change in neurofilament light (NfL) levels is an established biomarker for ALS progression, reflecting neuronal injury and degeneration, correlating with the rate of disease progression and shorter lifespan. Of the eight participants with available blood samples, NfL concentrations were reduced during IPL344 treatment in all but one participant. Six participants had blood sampling past the initial dose-escalating study. In these participants, plasma NfL concentrations were reduced by a mean of 20%, suggesting decrease of neuronal injury following IPL344 treatment. The detailed data are presented in the poster.

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“These biomarker data strengthen IPL344 potential as a potentially important therapy for ALS, adding to the drug’s previously reported safety and efficacy data,” said Dr. Ilana Cohen, Immunity Pharma’s VP of R&D.

About the Phase 2a ALS Clinical Trial

The Phase 1/2a trial was an open-label,  study with once-daily IPL344 treatment administered IV (home administration). Subjects were allowed to stay in the study for up to 3 years. The study includes a 28-day Phase 1 dose escalating portion, after which subjects may continue to the Phase 2a portion of the study. The study was conducted at the Hadassah Medical Center in Jerusalem (NCT03652805, NCT03755167).

The Phase 1/2a study included nine participants with probable or definite ALS and a progression rate >0.55 points/month on the ALS functional rating scale-revised (ALSFRS-R) that received open-label treatment with once-daily IPL344 for up to 36 months. Efficacy outcomes included the rate of progression on ALSFRS-R, slow vital capacity (SVC), weight, and survival compared with historical placebo from the PRO-ACT database and ceftriaxone study. The statistical analysis included a method previously proposed by Dr. Schoenfeld designed to quantify inter-center and inter-study variability, to pinpoint whenever ALSFRS-R slowdown exceeds the normal variability. This analysis shows that, despite the small number of participants the magnitude of ALSFRS-R slope reduction is larger than the threshold needed for significance and is beyond that expected by inter-study variation.

About IPL344

IPL344 is a biologically active peptide that stimulates therapeutic cell-signaling processes including activation of the Akt pathway, which is down-regulated in neurodegenerative diseases. IPL344 was discovered in the Weizmann institute of Science, Israel, at Prof. Irun Cohen's Laboratory. IPL344 is being developed as an intravenous injection for the treatment of ALS and has completed a Phase 1/2a clinical trial in ALS patients. IPL344 received orphan drug designation from FDA and EMA, which grants exclusivity for at least seven years. 

About Immunity Pharma

Immunity Pharma Ltd. (IPL) is a privately-held clinical-stage neurology-focused biopharmaceutical company that develops therapies for neurodegenerative diseases, with an initial focus on Amyotrophic lateral sclerosis (ALS). IPL’s drugs are biologically active peptides that stimulate therapeutic cell-signalling processes and mitigate progression of neurodegenerative diseases by inducing intra-cellular survival-supporting processes. IPL’s drugs are being developed as treatment for ALS, Parkinson’s disease and other neurodegenerative diseases.

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