bazlitoran (IMO-8400) / Aceragen - LARVOL DELTA

A phase 2 double-blinded, placebo-controlled trial of toll-like receptor 7,8,9 antagonist, IMO-8400, in dermatomyositis. (PubMed, J Am Acad Dermatol) - No abstract available

Clinical • Journal • P2 data • Dermatomyositis • Immunology • Myositis

Idera Pharmaceuticals announces efficacy data for IMO-8400 in preclinical models of lupus and psoriasis (Idera Pharmaceuticals, Inc) - The data presented at American Association of Immunologists (AAI) demonstrate that inhibition of TLR7, 8 and 9 with IMO-8400 suppressed the cycle between autoimmune antibody production and tissue damage, leading to improved renal function in lupus-prone mice; No treatment-related side effects were observed in the mice from IMO-8400 treatment at the doses employed in the study; Idera expects to submit an Investigational New Drug application for IMO-8400 to the FDA during the Q4 2012, and has selected lupus as the initial disease indication for clinical development

Anticipated IND filing • Data release • Lupus

Idera Pharmaceuticals reports first quarter 2013 financial results (Businesswire) - "...during the fourth quarter...to initiate Phase 2 clinical trials of IMO-8400 in other autoimmune disease indications, including lupus.”

Anticipated new P2 trial • Lupus

Idera Pharmaceuticals: Set to ride a 200% gain in 2014 (SeekingAlpha) - "With the safety and tolerability seen thus far with these results for IMO-8400 Idera has decided to add 12 more patients in an expansion cohort with a higher dosing regimen of 0.6 mg/kg."; Anticipated topline P2 data for expansion cohort end of 2Q 2014; Anticipated clinical development for IMO-9200 H2 2014.

Anticipated P2 data • New molecule • Psoriasis

Extension Study of IMO-8400 in Patients With Waldenström's Macroglobulinemia Who Completed Study 8400-401 (clinicaltrials.gov) - P1/2; N=24; Enrolling by invitation; Sponsor: Idera Pharmaceuticals, Inc.; Trial primary completion date: Feb 2016 ➔ Dec 2016

Trial primary completion date • Biosimilar • Hematological Malignancies

Idera Pharma: Wedbush PacGrow Healthcare Conference (Idera Pharmaceuticals, Inc) - Anticipated dose escalation data from P1/2 trial (NCT02092909) in Waldenstrom's macroglobulinemia and P1/2 trial (NCT02252146) in DLBCL in H1 2017

Anticipated P1/2 data • Diffuse Large B Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Idera Pharma: ASH 2015 (Idera Pharmaceuticals, Inc) - “Safety: IMO-8400 was generally well tolerated at dose levels of 0.6, 1.2 and 2.4 mg/kg (1.2 mg/kg twice) per week, The Maximum Tolerated Dose of IMO-8400 has not yet been identified”; “Clinical activity: In the highest dose cohort studied to date (2.4 mg/kg): There were 3 responses and 2 stable disease out of 6 patients with evaluable disease treated to date, Median time to first response ~10.5 weeks, Improvements in symptoms, hemoglobin and bone marrow were seen, One of these responders was refractory to ibrutinib”; “Summary: These data in patients with WM provide the first clinical evidence supporting inhibition of the TLR pathway as a potential therapeutic approach for B-cell lymphomas harboring the MYD88 L265P oncogenic mutation”

P1/2 data • Oncology

Idera announces presentation of positive data from phase 2 trial of TLR 7 and 9 antagonist in patients with moderate-to-severe plaque psoriasis (Idera Pharmaceuticals, Inc) - P2, N=44; NCT01622348; "48% of patients treated with either dose of IMO-3100 (12 of 25) demonstrated statistically significant improvements of 35% to 90% from baseline PASI scores compared with 0 of 12 in the placebo cohort (p<0.005)...Idera has determined that the next step is to conduct a Phase 2 clinical trial of IMO-8400 in patients with psoriasis...In this trial, 32 patients would be randomized...Idera anticipates initiating enrollment under this protocol during the second quarter of 2013."

Anticipated target enrollment • Anticipated trial initiation date • P2 data • Psoriasis

Idera announces clinical development progress in its autoimmune diseases program (Idera Pharmaceuticals, Inc) - P1, N=32; "Idera Pharmaceuticals...completed dosing in its Phase 1 trial of IMO-8400 in healthy subjects. In addition, the Company announced that its protocol for a Phase 2 study of IMO-8400 in patients with psoriasis has received “no objection” clearance from the Competent Authority of the Netherlands...The Company expects to report top-line data from the multiple-dose portion of the trial later in the second quarter of 2013"; P2, N=44; NCT01622348; "Top-line microarray results of the clinical samples show significant improvement of psoriasis disease-associated gene profile in patients treated with IMO-3100 compared to placebo"

Anticipated new P2 trial • Anticipated P1 data • P2 data • Regulatory • Trial status • Psoriasis

A Double-Blind, Placebo-Controlled, Phase 2 Trial of a Novel Toll-Like Receptor 7/8/9 Antagonist (IMO-8400) in Dermatomyositis (ACR-ARHP 2019) - "IMO-8400 did not reach clinical efficacy in reducing cutaneous DM disease activity nor in decreasing the type I IFN signature in skin or blood, suggesting that TLR7/8/9 signaling may not play a causal role in IFN dysregulation in DM. Furthermore, our exploratory findings suggest that skin type I IFN signature scores provide a stronger indication of DM skin disease activity than blood type I IFN signature scores and that skin type I IFN signaling may be a pathway to target in improving pruritus symptoms in DM patients."

Clinical • IO Biomarker • P2 data

Idera Pharmaceuticals announces completion of patient enrollment in phase 2 trial of IMO-3100 in patients with psoriasis (Idera Pharmaceuticals, Inc) - Idera anticipates initiating P1 dose escalation trial during the Q4 2012 to evaluate the safety and pharmacodynamics of IMO-8400 in healthy subjects; Also will be presenting preclinical data on IMO-8400 at major scientific meetings Q4 2012; Anticipated P1 data 2013; Anticipated P2 trial 2013

Anticipated new P1 trial • Anticipated new P2 trial • Anticipated P1 data

Idera announces presentation at AAD annual meeting demonstrating toll-like receptor antagonists normalize expression of inflammatory genes in psoriasis model (Idera Pharmaceuticals, Inc) - "Idera...announced the presentation of new data showing that its selective Toll-like receptor antagonists, IMO-3100 and IMO-8400, normalized the gene expression of important cytokines in a preclinical study of skin inflammation that is commonly used as a model of psoriasis...genes related to the production of key mediators of psoriasis including Interleukin (IL) -17, IL-6, IL-12/23, IL-1, IL-21 Receptor, and INF-gamma were restored toward normal levels..." Anticipated presentation of P2 detailed results from the clinical trial at the International Investigative Dermatology Annual Meeting in May 2013; Anticipated P1 data of IMO-8400 in Q2 2013.

Anticipated P1 data • Anticipated P2 data • Preclinical

IMO-8400: Expiry of patents related to chemical composition-of-matter and certain methods of use in US in 2031 (Idera Pharmaceuticals, Inc) - Annual Report 2018:

Patent

Trial of IMO-8400 in Adult Patients With Dermatomyositis (clinicaltrials.gov) - P2; N=30; Completed; Sponsor: Idera Pharmaceuticals, Inc.; Active, not recruiting ➔ Completed; Trial completion date: Dec 2018 ➔ Jun 2018

Clinical • Trial completion • Trial completion date