IPL344 / Immunity Pharma - LARVOL DELTA

Immunity Pharma Presents New Data Supporting the Efficacy of IPL344 in ALS (PRNewswire) - P1/2 | N=15 | NCT03652805 | Sponsor: Immunity Pharma Ltd | "Results from phase 2a trial in ALS patients were published in Muscle and Nerve; Statistically significant 58% to 64% slower ALSFRS-R progression rate in IPL344-treated patients compared to the matched PRO-ACT records; NfL was reduced by 27% for patients treated for at least two months; Unadjusted median survival for participants in the IPL344 group was 43.4 months compared with 19.1 months in the historical control group; IPL344 was safe and well-tolerated."

P1/2 data • Amyotrophic Lateral Sclerosis

Akt Activation With IPL344 Treatment for Amyotrophic Lateral Sclerosis: First in Human, Open-Label Study. (PubMed, Muscle Nerve) - "These preliminary data indicate that IPL344 was safe and well-tolerated, and possibly effective. Our findings may merit further investigation in a larger placebo-controlled clinical trial."

Clinical • Journal • P1 data • Amyotrophic Lateral Sclerosis • CNS Disorders • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases • NEFL • Plasma NfL

A Study of IPL344 in the Treatment of ALS Patients (clinicaltrials.gov) - P1/2 | N=15 | Suspended | Sponsor: Immunity Pharma Ltd. | Trial completion date: Feb 2025 ➔ Feb 2026 | Trial primary completion date: Jan 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders

A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV (clinicaltrials.gov) - P2 | N=15 | Suspended | Sponsor: Immunity Pharma Ltd. | Trial completion date: Feb 2026 ➔ Feb 2027 | Trial primary completion date: Jan 2026 ➔ Jan 2027

Trial completion date • Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders

Immunity Pharma Announces Positive Top Line Results from Phase 2a Trial with IPL344 in ALS Patients (PRNewswire) - P1/2a | N=15 | NCT03652805 | Sponsor: Immunity Pharma Ltd. | "Immunity Pharma...announced positive top line results from the Phase 2a trial with IPL344 in amyotrophic lateral sclerosis (ALS) patients....Median survival of patients in this study was 29 months vs. 19 months of placebo treated patients in the ceftriaxone study (post-treatment follow-up is still ongoing), indicating a trend toward reduced risk of death in favor of IPL344 (p=0.13). There was a non-significant trend for preserved respiration capacity (44% slower reduction in average %SVC loss per month vs. historical placebo; p=0.15). Biomarker data for plasma neurofilament light (NfL) levels were obtained for eight subjects. NfL concentrations were reduced during IPL344 treatment in all but one participant."

P2a data • Amyotrophic Lateral Sclerosis • CNS Disorders

A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV (clinicaltrials.gov) - P2 | N=15 | Suspended | Sponsor: Immunity Pharma Ltd. | Trial completion date: Dec 2022 ➔ Feb 2026 | Recruiting ➔ Suspended

Trial completion date • Trial suspension • Amyotrophic Lateral Sclerosis • CNS Disorders

A Study of IPL344 in the Treatment of ALS Patients (clinicaltrials.gov) - P1/2 | N=15 | Suspended | Sponsor: Immunity Pharma Ltd. | Trial completion date: Aug 2022 ➔ Feb 2025 | Unknown status ➔ Suspended

Trial completion date • Trial suspension • Amyotrophic Lateral Sclerosis • CNS Disorders

Neurofilament light chain level in plasma of ALS patients following IPL344 treatment in phase 1/2a clinical trial (NCT03652805 NCT03755167) (ALS-MND 2023) - P1/2, P2 | "We previously reported ALSFRS-R slope reduction of 64% in this clinical study. The reduction of NfL levels and the correlation between NfL reduction and ALSFRS-R slope reduction following IPL344 treatment supports a disease modifying effect. Moreover, these data further support the use of NfL as a valid outcome measure in ALS treatment trials."

Clinical • P1/2 data • Amyotrophic Lateral Sclerosis • CNS Disorders • Frontotemporal Lobar Degeneration • NEFL • Plasma NfL

Immunity Pharma Announces Promising Interim Results of its Phase 1/2a Study with IPL344 in ALS (PRNewswire) - P1/2a, N=15; NCT03652805; Sponsor: Immunity Pharma; “Immunity Pharma…announced today interim results from its Phase 1/2a clinical study with IPL344, an Akt activating disease-modifying drug for the treatment of ALS. In this early stage clinical trial, disease progression rate during IPL344 treatment was about 50% slower than expected without treatment, in both functional and respiratory endpoints (ALSFRS-R and SVC, respectively).”

P1/2 data • Amyotrophic Lateral Sclerosis • CNS Disorders

A Study of IPL344 in the Treatment of ALS Patients (clinicaltrials.gov) - P1/2; N=15; Recruiting; Sponsor: Immunity Pharma Ltd.; Trial completion date: Aug 2020 ➔ Aug 2022; Trial primary completion date: Jul 2020 ➔ Jul 2022

Clinical • Trial completion date • Trial primary completion date • Amyotrophic Lateral Sclerosis • CNS Disorders • Complement-mediated Rare Disorders • Pain

A Follow up Study to Protocol 101/2 - Continued Treatment by IPL344 IV (clinicaltrials.gov) - P2; N=15; Recruiting; Sponsor: Immunity Pharma Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open

A Study of IPL344 in the Treatment of ALS Patients (clinicaltrials.gov) - P1/2; N=15; Recruiting; Sponsor: Immunity Pharma Ltd.; Trial completion date: Aug 2019 ➔ Aug 2020; Trial primary completion date: Jul 2019 ➔ Jul 2020

Clinical • Trial completion date • Trial primary completion date