Company Product Description Indication Status
Phase I
Aiviva Biopharma Inc., of Newport Beach, Calif. AIV-001 Intradermally administered small molecule Superficial or nodular basal cell carcinoma Started dosing patients with biopsy-confirmed disease; phase I/II trial to enroll 18 subjects studied in 2 ascending-dose cohorts
Astrazeneca plc, of Cambridge, U.K. AZD-1222 Vaccine COVID-19 Phase I/II study resumed in Japan after discussion with regulators
Xencor Inc., of Monrovia, Calif. Tidutamab (XmAb-18087) SSTR2 x CD3 bispecific antibody Neuroendocrine tumors Initial data from ongoing trial showed treatment generally well-tolerated at recommended dose, a 0.3-mcg/kg priming dose and subsequent 1-mcg/kg repeated doses; CD8-positive effector T cells showed dose-dependent increase in proliferation (Ki67) and activation (PD-1) markers that began within 48 hours of first dose and persisted at least 7 weeks, as measured at cycle 2, day 22; best overall response was stable disease, with disease control rate of 43% and median duration of treatment of about 7 months
Phase II
Algernon Pharmaceuticals Inc., of Vancouver, British Columbia NP-120 (ifenprodil) NMDA receptor antagonist COVID-19 Enrolled 75% of target for phase IIb/III study
Epygenix Therapeutics Inc., of Paramus, N.J. EPX-100 First-generation antihistamine Dravet syndrome Enrolled first patient in 20-week study testing drug as adjunctive therapy in children
Kyowa Kirin Co. Ltd., of Tokyo, and Mei Pharma Inc., of San Diego Zandelisib (ME-401) Oral, once-daily selective PI3K-delta inhibitor Indolent B-cell non-Hodgkin lymphoma Dosed first patient in pivotal study in patients without small lymphocytic lymphoma, lymphoplasmacytic lymphoma and Waldenström's macroglobulinemia in Japan; trial will evaluate monotherapy in patients with relapsed or refractory iNHL with at least 2 prior systemic therapies
Synthetic Biologics Inc., of Rockville, Md. SYN-010 Modified-release formulation of lovastatin lactone Irritable bowel syndrome with constipation Planned interim futility analysis of phase IIb study showed drug well-tolerated but unlikely to meet primary objective; sponsor Cedars-Sinai Medical Center agreed to discontinue trial and conduct comprehensive review
Phase III
Cytokinetics Inc., of South San Francisco Omecamtiv mecarbil Selective cardiac myosin activator Heart failure Data detailing baseline characteristics from Galactic-HF event-driven cardiovascular outcomes trial were published in the European Journal of Heart Failure; patients enrolled were required to have a diagnosis of HFrEF with left ventricular ejection fraction ≤35% and elevated natriuretic peptides; patients were either currently hospitalized for heart failure (25% of total enrollment), or had a recent hospitalization, or a visit to an emergency room or urgent care facility for heart failure within the preceding year
Otonomy Inc., of San Diego Otividex  Sustained-exposure formulation of dexamethasone Ménière’s disease Completed enrollment with 149 patients; results expected in first quarter of 2021
RVL Pharmaceuticals Inc., of Bridgewater, N.J., a subsidiary of Osmotica Pharmaceuticals plc Upneeq (oxymetazoline hydrochloride ophthalmic solution 0.1%) Adrenergic receptor agonist Acquired blepharoptosis (ptosis) Pooled analysis from 2 studies comprising 304 patients showed increase from baseline in mean number of points seen on superior visual field (Leicester Peripheral Field Test) was 5.9 ± 6.4 vs. 1.8 ± 4.1 for vehicle (p<0.001) on day 1; 7.1 ± 5.9 vs. 2.4 ± 5.5 for vehicle (p<0.001) on day 14; increase from baseline in upper eyelid elevation was .96 ± 0.89 mm vs. 0.50 ± 0.81 mm for vehicle (p<0.001) for day 1 and 16 ± 0.87 mm vs. 0.50 ± 0.80 mm for vehicle on day 14; data published in JAMA Ophthalmology 

Notes

For more information about individual companies and/or products, see Cortellis.