Company

Product

Description

Indication

Status

Phase I

Afyx Therapeutics, of Copenhagen, Denmark

Rivelin bioadhesive patch

Undisclosed

Vulvar lichen sclerosus

All 12 patients were able to self-apply the patch to the lesions; mean adhesive time was more than 9 hours; plans to proceed with testing of patch that delivers an undisclosed drug

Annexon Biosciences Inc., of South San Francisco

ANX-007

Monoclonal antibody antigen-binding fragment targeting C1q

Glaucoma

The 2 higher doses of ANX-007 achieved complete suppression of the C1q target for at least 4 weeks in phase Ib trial, as measured in ocular fluid from aqueous humor taps; plans to advance the drug into geographic atrophy and other ophthalmic diseases

Debiopharm Group, of Lausanne, Switzerland

Debio-1143

Antagonist of inhibitor of apoptosis proteins

Non-microsatellite instability-high colorectal cancer and pancreatic ductal adenocarcinoma cancer

Enrolled first of up to 46 patients in the Catripca study testing Debio-1143 with anti-PD-1 Keytruda (pembrolizumab, Merck & Co. Inc.); study includes dose-escalation and expansion phases with objective response rate as the primary endpoint

Eyegate Pharmaceuticals Inc., of Waltham, Mass.

Ocular Bandage Gel

Modified form of the polymer hyaluronic acid

Punctate epitheliopathies

Enrolled first patient in study to evaluate several exploratory performance endpoints

Faron Pharmaceuticals Oy, of Turku, Finland

Clevegen

Targets clever-1-positive tumor-associated macrophages

Metastatic or inoperable solid tumors

Immune activation, defined as increased circulating CD8+ T cells and CD8+/CD4+ ratio, decreased regulatory T cells, or a substantial increase in mobile natural killer cells in the blood, observed in all 11 patients in part I of the study; increase in circulating B cells was observed during cycles 3 and 4 of the treatment; lowest doses of 0.3 mg/kg and 1 mg/kg had strongest immune response, so part 1 will be expanded to 30 patients to test a dose of 0.1 mg/kg before moving to part II

Phase II

Anavex Life Sciences Corp., New York

Anavex2-73 (blarcamesine)

Targets sigma-1 and muscarinic receptors

Early Alzheimer's disease

Started the phase Ib/III Attention-AD extension study of the Anavex2-73-AD-004 study testing treatment for an additional 2 years

EMD Serono, of Rockland, Mass., a unit of Merck KGaA

Sprifermin

Recombinant human fibroblast growth factor-18

Symptomatic radiographic knee osteoarthritis

Data published in the Journal of the American Medical Association showed primary endpoint, defined as change in total femorotibial joint cartilage thickness from baseline at 2 years vs. placebo as measured by quantitative MRI, was met; mean increase in cartilage thickness observed in 2 sprifermin groups receiving highest doses vs. placebo group, with statistical significance at +0.05 mm and +0.04 mm, respectively; 2-year changes with lower dose showed no significant differences vs. placebo; in 3-year follow-up analysis, statistically significant difference (+0.05 mm) in cartilage thickness vs. placebo for 100-µg dosed every 6 months was maintained

Galderma Pharma SA, of Lausanne, Switzerland

QM-1114

Botulinum toxin

Glabellar lines

Drug demonstrated safety and efficacy at all doses with high patient satisfaction; plans to run a phase III program with 1,500 patients

Intelgenx Corp., of Saint Laurent, Quebec

Montelukast Versafilm

Leukotriene inhibitor

Mild to moderate Alzheimer's Disease

The data safety monitoring board recommended the phase IIa trial continue following the review of data from the first 25 patients, including 13 who have completed 26 weeks of treatment

Oncologie Inc., of Boston

Bavituximab

Monoclonal antibody targeting phosphatidylserine

Advanced gastric or gastroesophageal cancer

Enrolled first of about 80 patients in study testing bavituximab plus anti-PD-1 Keytruda (pembrolizumab, Merck & Co. Inc.); primary endpoint is antitumor activity of the combination, as well as safety and tolerability; drug levels, the effect of treatment on target proteins and an exploratory analysis of RNA biomarker signatures will also be measured

Phase III

Dermira Inc., of Menlo Park, Calif.

Lebrikizumab

Monoclonal antibody targeting IL-13

Moderate to severe atopic dermatitis

First patient dosed in program that will enroll about 800 patients in 2 identical studies; primary efficacy endpoint is the percentage of patients with an Investigator's Global Assessment 0/1 response from baseline to week 16; top-line data expected during the first half of 2021

Eyegate Pharmaceuticals Inc., of Waltham, Mass.

Ocular Bandage Gel

Modified form of the polymer hyaluronic acid

Corneal wound repair following photorefractive keratectomy surgery

Completed randomization of 234 patients into the study; top-line data expected by the end of 2019

Sun Pharmaceutical Industries Ltd., of Mumbai, India

Ilumya (tildrakizumab-asmn)

Humanized lgG1/k monoclonal antibody that binds to p19 subunit of interleukin-23

Plaque psoriasis

Long-term follow-up data showed that response rates seen in initial 52 and 64 weeks, respectively, were maintained over 4 years in patients with moderate to severe disease; more than half of patients achieved at least 90% skin clearance; additional analyses showed that 75% to 100% skin clearance achieved over 3 years was sustained equally in people with and without metabolic syndrome

Notes

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