quisovalimab (AVTX-002) / Kyowa Kirin, Avalo Therap - LARVOL DELTA

A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma. (clinicaltrials.gov) - P2 | N=91 | Completed | Sponsor: Avalo Therapeutics, Inc. | Active, not recruiting ➔ Completed

Trial completion • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Avalo Announces Topline Data from Phase 2 PEAK Trial for AVTX-002 (quisovalimab) in Patients with Non-Eosinophilic Asthma (GlobeNewswire) - P2 | N=80 | NCT05288504 | Sponsor: Avalo Therapeutics, Inc. | "Avalo Therapeutics...today announced topline results from the Phase 2 randomized, double-blind, placebo-controlled trial (PEAK trial) evaluating AVTX-002 (anti-LIGHT mAb) in patients with poorly controlled non-eosinophilic asthma (NEA). The trial did not meet its primary endpoint, measured by the reduction in asthma-related events. AVTX-002 demonstrated a favorable safety and tolerability profile....AVTX-002 significantly reduced LIGHT levels for the study duration indicating target engagement. Additionally, an exploratory analysis revealed a positive trend in reduction of asthma related events in patients treated with AVTX-002 as compared to placebo within a substantial sub-population of patients with elevated baseline LIGHT levels."

P2 data • Asthma • Respiratory Diseases

Avalo to Present at ATS 2023 Respiratory Innovation Summit (BioSpace) - "Avalo Therapeutics...announced today that Garry A. Neil, M.D., Chief Executive Officer and Chairman of the Board, will attend and present at the ATS 2023 Respiratory Innovation Summit (RIS), hosted by the American Thoracic Society, on May 19-20, 2023 in Washington, DC. Dr. Neil will present on AVTX-002 in non-eosinophilic asthma during Showcase One: Asthma, COPD, and Airway Inflammation Innovators at 8:30am ET on Saturday, May 20, 2023."

Clinical • Asthma • Chronic Obstructive Pulmonary Disease

Avalo Reports First Quarter 2023 Financial Results and Provides Business Updates (GlobeNewswire) - "Program Updates and Milestones: AVTX-002: Anti-LIGHT monoclonal antibody (mAb) targeting immune-inflammatory diseases. NEA: Avalo has completed enrollment of the Phase 2 PEAK trial evaluating the safety and efficacy of AVTX-002 in 91 patients with NEA. Topline data expected in the second quarter of 2023. AVTX-008: B and T Lymphocyte Attenuator (BTLA) agonist fusion protein targeting immune dysregulation disorders. Avalo identified a lead molecule and is currently evaluating several immune dysregulation disorders, with a target IND submission planned in 2024."

IND • P1/2 data • Asthma • Immunology • Inflammation • Respiratory Diseases

A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma. (clinicaltrials.gov) - P2 | N=80 | Active, not recruiting | Sponsor: Avalo Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma. (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Avalo Therapeutics, Inc. | Trial completion date: Sep 2022 ➔ Mar 2023 | Trial primary completion date: Sep 2022 ➔ Mar 2023

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Avalo Therapeutics Announces First Patient Dosed in the Phase 2 PEAK Trial of AVTX-002 for the Treatment of Non-Eosinophilic Asthma (NEA) (GlobeNewswire) - "Avalo Therapeutics...announced that the first patient has been dosed in the company’s Phase 2 PEAK (A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma K) trial evaluating AVTX-002 for the treatment of non-eosinophilic asthma (NEA)....The PEAK trial (n=approximately 80) is a 12-week randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of AVTX-002 for the treatment of poorly controlled NEA (NCT05288504)."

Trial status • Asthma • Immunology

A Study to Evaluate the Safety and Efficacy of AVTX-002 for the Treatment of Poorly Controlled Non-Eosinophilic Asthma. (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Cerecor Inc

New P2 trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis (clinicaltrials.gov) - P1 | N=8 | Terminated | Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company | N=14 ➔ 8 | Trial completion date: Sep 2022 ➔ Oct 2021 | Recruiting ➔ Terminated | Trial primary completion date: Sep 2022 ➔ Sep 2021; Strategic reasons

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Avalo Therapeutics Reports 2021 Financial Results and Provides Business Updates (GlobeNewswire) - Avalo Therapeutics, Inc...today announced business updates and year-end financial results for 2021....As Avalo intends to focus on placebo-controlled trials for AVTX-002 going forward, we will not be moving forward with the uncontrolled cohort of AVTX-002 in UC patients. Avalo will consider planning for a possible randomized, double-blind, placebo-controlled clinical study in moderate to severe refractory patients in inflammatory bowel disease."

Clinical protocol • Crohn's disease • Inflammation • Inflammatory Bowel Disease

Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis (clinicaltrials.gov) - P1; N=14; Recruiting; Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company; Trial completion date: Oct 2021 ➔ Sep 2022; Trial primary completion date: Sep 2021 ➔ Sep 2022

Clinical • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Avalo Reports Positive Phase 1b Results for AVTX-002 in Moderate to Severe Crohn’s Disease Patients and Presents Additional Program Updates at 2022 Investor Event (Yahoo News) - P1, N=8; NCT03169894; Sponsor: Aevi Genomic Medicine, LLC; "Avalo Therapeutics, Inc...today provides a comprehensive update on the Company’s growth opportunities and mid-stage development portfolio. AVTX-002 Phase 1b Crohn’s Disease (CD) Clinical Trial Results....Clinically meaningful mucosal healing, determined by colonoscopy and adjudicated by a central reader, was observed in fifty percent (4/8) of subjects with one subject achieving remission (SES-CD = 0)....Seventy-five percent (3/4) of patients that demonstrated mucosal healing by colonoscopy reported they had returned to doing poorly two to three months after cessation of study drug, suggesting a drug-related effect...The Company is currently evaluating AVTX-002 in a cohort of ulcerative colitis (UC) patients with moderate to severe UC who are refractory to biologic therapy, including anti-TNFα, with data anticipated in the third quarter of 2022..."

Clinical data • P1 data • Crohn's disease • Inflammation • Inflammatory Bowel Disease

Avalo Therapeutics to Host Virtual Investor Day on January 6, 2022 (GlobeNewswire) - "Avalo Therapeutics, Inc...today announced it will host a virtual investor day that will be held on Thursday, January 6th from 8:00 a.m. to 10:00 a.m. ET....The event will provide a comprehensive update on Avalo’s lead programs and clinical-stage pipeline, including: Update on the Phase 1b proof-of-concept study of AVTX-002 in Crohn’s disease, upcoming plans in ulcerative colitis and discuss the long-term product development plans, including new indications"

P1 data • Crohn's disease • Inflammatory Bowel Disease

Randomized, double-blind, controlled trial of human anti-LIGHT monoclonal antibody in COVID-19 acute respiratory distress syndrome. (PubMed, J Clin Invest) - P2 | "For patients with COVID-19-associated ARDS, adding CERC-002 to standard of care treatment reduces LIGHT levels and might reduce the risk of respiratory failure and death."

Clinical • Journal • Acute Respiratory Distress Syndrome • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • TNFSF14

CERC-002: “No serious adverse events attributes to the study drug“; Crohn’s disease (Cerecor) - CERC-002 Results in Moderate to Severe Crohn's Disease

P1 data • Crohn's disease • Inflammatory Bowel Disease

Cerecor Reports Second Quarter 2021 Financial Results and Provides Business Updates (GlobeNewswire) - "The Company announced the completion of enrollment in Cohort 2 (3.0 mg/kg) of its Phase 1b proof-of-concept study of CERC-002 in moderate-to-severe Crohn’s disease and anticipates data in the second half of 2021."

Enrollment status • P1 data • Crohn's disease • Inflammatory Bowel Disease

Cerecor Announces Drawdown of $10 Million Tranche under its Debt Financing Agreement with Horizon Technology Finance (GlobeNewswire) - "Cerecor Inc...announced that it has completed its second drawdown of $10 million under its previously announced $35 million debt financing agreement with Horizon Technology Finance Corporation...This second tranche was made available in connection with the Company’s successful positive initial results from a Phase 1b proof-of-concept study evaluating CERC-002, an investigational first-in-class fully human anti-LIGHT (tumor necrosis factor superfamily member 14 (TNFSF14)) monoclonal antibody, in adult patients with moderate- to-severe Crohn's disease..."

Financing • Crohn's disease • Inflammatory Bowel Disease

Cerecor Announces Positive Initial Phase 1b Results for CERC-002 in Moderate to Severe Crohn's Disease Patients (GlobeNewswire) - P1, N=8; NCT03169894; "Cerecor Inc...announced positive initial results from a Phase 1b proof-of-concept study evaluating CERC-002, an investigational first-in-class fully human anti-LIGHT (tumor necrosis factor superfamily member 14 (TNFSF14)) monoclonal antibody, in adult patients with moderate to severe Crohn's disease (CD)....The adverse events observed in study subjects were mild to moderate with the most common adverse events associated with the gastrointestinal track and the underlying Crohn’s disease; There were no treatment emergent serious adverse events attributed to CERC-002."

P1 data • Crohn's disease • Inflammatory Bowel Disease

Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease (clinicaltrials.gov) - P1; N=8; Recruiting; Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company; Trial completion date: Jul 2019 ➔ Oct 2021; Trial primary completion date: Jun 2019 ➔ Sep 2021

Clinical • Trial completion date • Trial primary completion date • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

Cerecor Reports First Quarter 2021 Financial Results and Provides Business Updates (GlobeNewswire) - "The Company is continuing to enroll patients in its Phase 1b trial in severe pediatric-onset Crohn’s disease with initial data expected in the second quarter and is exploring the applicability of CERC-002 in non-COVID-19 ARDS."

Enrollment status • P1 data • Crohn's disease • Inflammatory Bowel Disease

FDA Grants Fast Track Designation to CERC-002 for Treatment of Hospitalized Patients with COVID-19 (GlobeNewswire) - "Cerecor Inc....announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CERC-002 for treatment of hospitalized patients with COVID-19....Under Fast Track designation, a Biologic License Application (BLA) for CERC-002 is eligible for both rolling submission and priority review."

Fast track designation • Infectious Disease • Novel Coronavirus Disease

Cerecor Announces New Worldwide License Agreement with Kyowa Kirin for Anti-LIGHT Antibody CERC-002 (GlobeNewswire) - "Cerecor Inc....announced that its wholly-owned subsidiary, Aevi Genomic Medicine, LLC ('Cerecor'), has entered into an expanded agreement with Kyowa Kirin....Cerecor will receive exclusive rights for the development, manufacturing and commercialization of the antibody for all indications worldwide including the United States, Europe and Japan. Kyowa Kirin has an option to retain the rights in Japan. Kyowa Kirin will receive an up-front payment from Cerecor and is also eligible to receive additional payments based on achievement of regulatory and commercial milestones, as well as sales-based royalties and a share of sublicensing income."

Cytokine storm • Licensing / partnership • Acute Respiratory Distress Syndrome • Crohn's disease • Infectious Disease • Inflammatory Bowel Disease • Novel Coronavirus Disease

Cerecor Reports 2020 Financial Results and Provides Business Updates (GlobeNewswire) - "CERC-002:...The company is continuing to enroll patients in its Phase 1b trial in severe pediatric-onset Crohn’s disease with initial data expected in the second quarter..."

Enrollment status • P1 data • Crohn's disease • Inflammatory Bowel Disease

Cerecor Announces CERC-002 Significantly Reduced Respiratory Failure and Mortality in Phase 2 Clinical Trial in Patients Hospitalized with COVID-19 ARDS (GlobeNewswire) - P2, N=83; NCT04412057; Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company; "The final analysis inclusive of the 60-day safety update demonstrated the trial met its primary efficacy endpoint...Efficacy was highest in a prespecified subpopulation of patients over the age of 60 (n=34, p=0.042)...At both the 28-day and the 60-day final timepoints, an approximately 50% trend in mortality reduction (22.5% vs 10.8%) was observed. CERC-002 showed statistically significant efficacy on top of corticosteroids and standard of care treatments in COVID-19 ARDS...Cerecor has submitted applications to the U.S. Food and Drug Administration (FDA) for Breakthrough Therapy and Fast Track Designations. The Company plans to meet with FDA to discuss the potential path to Emergency Use Authorization (EUA) and approval."

Breakthrough therapy designation • Fast track designation • P2 data • Acute Respiratory Distress Syndrome • Infectious Disease • Novel Coronavirus Disease

Clinical Trial to Evaluate CERC-002 in Adults With COVID-19 Pneumonia and Acute Lung Injury (clinicaltrials.gov) - P2; N=83; Completed; Sponsor: Aevi Genomic Medicine, LLC, a Cerecor company; Recruiting ➔ Completed

Clinical • Trial completion • Acute Lung Injury • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases