RE: Funding / Cash Position29 Jan 2024 09:16
For what it's worth this is a brief appraisal. Lots of info around Avion and Immupharma and funding but here's the basics.
A brief synopsis from Phase2 forward:
Rigerimod - Lupuzor (Immupharma)
Lupuzor administered at 200 µg once a month for 3 months achieved a clinically significant improvement in patient response rate in comparison with placebo.
From: Dubois' Lupus Erythematosus and Related Syndromes (Eigth Edition), 2013
Lupuzor, being developed by ImmuPharma, is a potentially revolutionary peptide-based therapy for SLE, because, contrary to other immunomodulating therapies, it suppresses the activation of auto-reactive T-cells — immune cells that attack the body’s own tissues — without affecting healthy immune cells.
2018 Lupuzor’s aim is to potentially eliminate autoimmunity without the need for immunosuppression, allowing the occurrence of normal immune responses.
Participants were randomly assigned to receive 200 micrograms of either Lupuzor under the skin or a placebo in addition to standard therapy every four weeks for 48 weeks.
An analysis of all 202 participants showed that more patients had a reduction in disease activity with Lupuzor combined with standard therapy (52%) than with standard therapy alone (44.6%), but the difference was not statistically significant.
Among the 153 patients who completed the study, Lupuzor also showed a superior response rate compared with placebo (68.8% vs 59.2%), but this was not statistically significant.
In patients with anti-dsDNA autoantibodies — a recognized biomarker for SLE — clinical response was achieved by a higher proportion of patients receiving Lupuzor (61.5%) than those receiving placebo (47.3%). Notably, 7.6% of these patients in the Lupuzor group went into full remission, compared with none in the placebo group.
Results also confirmed that the treatment is very safe, with no serious adverse events reported
In the forthcoming Phase 3 trial.
The trial design and protocol is substantially different from previous clinical trials that ImmuPharma has completed and includes maintaining subcutaneous dosing but at much higher concentrations and significant changes to patient inclusion criteria and primary and secondary clinical endpoints.