Company

Product

Description

Indication

Status

Phase I

Noveome Biotherapeutics Inc., of Pittsburgh

ST-266

Secretome biologic administered as nasal spray

Intraocular hypertension

Started open-label trial to test safety in patients who have not yet developed optic nerve damage

Vaccinex Inc., of Rochester, N.Y.

Pepinemab

Semaphorin 4D-blocking monoclonal antibody

Non-small-cell lung cancer

Interim phase Ib/II data testing drug in combination with Bavencio (avelumab) showed 59% of patients (17/29) whose tumors had progressed during or following treatment with checkpoint inhibitors appeared to benefit from switching to the combination; among the 17 responders, 2 had partial responses with 49% and 37% tumor reductions on combination therapy, and 15 experienced stable disease; in cohort of immunotherapy-naïve patients (n=18), 5 subjects experienced PR, 3 have experienced durable clinical benefit for > 1 year at data cutoff, and disease control rate is 81%

Phase II

Nicox SA, of Sophia Antipolis, France

NCX-4251

Ophthalmic suspension of fluticasone propionate nanocrystals

Blepharitis

Completed enrollment in trial testing drug in acute exacerbations of blepharitis; top-line data expected in the fourth quarter of 2019

Phase III

Nabriva Therapeutics plc, of Dublin

Lefamulin

Semi-synthetic pleuromutilin antibiotic

Community-acquired bacterial pneumonia

Journal of the American Medical Association published results from Leap 2 trial, showing a short-course treatment (5 days) was noninferior to a 7-day regimen of moxifloxacin; lefamulin achieved high clinical response rates for both typical and atypical pathogens

Pfizer Inc., of New York

Abrocitinib

Oral JAK1 inhibitor

Moderate to severe atopic dermatitis

Top-line data from Jade Mono-2, the second pivotal study, testing monotherapy in patients 12 and older showed that by week 12, percentage of patients achieving each co-primary endpoint and each key secondary endpoint with either dose was statistically significant vs. placebo; in addition, a statistically significant number of patients achieved reduction in pruritus by week 2, as measured by 4-point or larger reduction in itch severity using pruritus numerical rating scale

Sunovion Pharmaceuticals Inc., of Marlborough, Mass., and Psychogenics Inc., of Paramus, N.J.

SEP-363856

Believed to activate TAAR1 and 5-HT1A receptors

Schizophrenia

Initiated Diamond studies; program includes 4 trials: a 6-week study in acutely psychotic adults and adolescents (13 to 17); a 6-week study in acutely psychotic adults with schizophrenia; a 52-week trial in adults and adolescents who completed either of 6-week studies; and a 52-week comparator-controlled, long-term safety study in adults with schizophrenia

Notes

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