Company Product Description Indication Status
Phase I
Flexion Therapeutics Inc., of Burlington, Mass. FX-201 IL-1Ra gene modulator Knee osteoarthritis Trial to advance into high-dose cohort following review by independent data monitoring committee of middle dose safety data; trial also expanded to include up to 20 additional participants in both low and mid-dose groups
Ultimovacs ASA, of Oslo, Norway TENDU-1 Tetanus-epitope targeting vaccine Relapsed prostate cancer First participant dosed; efficacy endpoints include immunological responses such as activation of T cells and antitumor activity; first interim safety data expected by year-end 2021
Vtv Therapeutics Inc., of High Point, N.C. HPP-737 PDE4 inhibitor Psoriasis Trial initiated in healthy adults to determine maximum tolerated dose; study expected to finish in second quarter of 2021
Phase II
Devonian Health Group Inc., of Quebec City Thykamine (PUR-0110) IL-1 beta/TNF alpha ligand modulator Mild to moderate atopic dermatitis Administered at 0.1%, study drug showed improvement vs. placebo on primary endpoint of IGA at all measured time lines (week 1: p=0.006; week 2: p<0.001; week 3: p<0.001; week 4: p=0.002) and, at doses of 0.05% and 0.1%, achieved statistically significant differences vs. placebo in key secondary efficacy endpoint of body surface area after 2 weeks (p=0.036 and p=0.001, respectively), 3 weeks (p=0.02 and 0.002) and 4 weeks (p=0.04 and p=0.004)
Helix Biopharma Corp., of Richmond Hill, Ontario L-DOS47 Immunoconjugate Lung adenocarcinoma Study testing combination with vinorelbine/cisplatin suspended; study halted due to other budgetary priorities
Helsinn Group, of Lugano, Switzerland Valchlor (mechlorethamine hydrochloride topical gel) Nitrogen mustard cytotoxic agent  Cutaneous T-cell lymphoma Analysis of pivotal study data, published in Clinical Lymphoma Myeloma and Leukemia, showed by-time post-hoc analyses of clinical response complemented traditional overall response rate analysis, showing improved response rates over time during 12-month treatment period; prespecified analysis, published in Journal of Investigative Dermatology, showed bioanalytic testing indicated lack of systemic absorption of study drug in plasma samples from pivotal study
Immunic Inc., of New York IMU-838 (vidofludimus) Dihydroorotate dehydrogenase inhibitor Primary sclerosing cholangitis Per protocol (PP) population (n=11) showed statistically significant decrease in ALP levels (p=0.041) after 24 weeks of treatment (30 mg once daily) compared to baseline; 3 of 11 PP participants (27.3%) achieved primary outcome measure of reduction of ALP at week 24 >/= 25%, compared to baseline, and AST increase at week 24 of no more than 33% vs. baseline 
Kyowa Kirin Co. Ltd., of Tokyo KHK-4083 OX40 ligand inhibitor Atopic dermatitis Study in 274 participants met primary endpoint; all cohorts achieved statistically significant superiority to placebo in EASI percentage change from baseline at 16 weeks
Nordic Nanovector ASA, of Oslo, Norway Betalutin (177Lu lilotomab satetraxetan) B-lymphocyte antigen CD20 stimulator; CD37 antagonist Follicular lymphoma Ongoing phase IIb Paradigme trial in third-line relapsed/refractory disease showed improved recruitment rate, with 73 people enrolled as of Feb. 17, 2021; following discussions with FDA and internal review, data set to support regulatory filing expected to be achieved with target population of 120 vs. initial target of 130; top-line data still expected in second half of 2021
Ocuphire Pharma Inc., of Farmington Hills, Mich. Nyxol (phentolamine mesylate eye drops) Alpha 1/alpha 2 adrenoceptor antagonist Presbyopia First of about 152 participants enrolled in Vega-1 trial evaluating study drug dosed at 0.75% in combination with low dose (0.4%) pilocarpine; primary endpoint is percentage with at least 3 lines (15 letters or >) improvement in binocular distance corrected near visual acuity on standard near vision eye chart in daytime lighting
Pfizer Inc., of New York, and Biontech SE, of Mainz, Germany BNT-162b2 (Pfizer-Biontech COVID-19 vaccine) RNA vaccine  COVID-19 First participants dosed in phase II/III study testing safety, tolerability and immunogenicity of vaccine in preventing COVID-19 in healthy pregnant women 18 and older
Vtv Therapeutics Inc., of High Point, N.C. HPP-737 PDE4 inhibitor Chronic obstructive pulmonary disease Partner Newsoara Biopharma Co. Ltd. advanced agent into study in China
Phase III
Dermavant Sciences Inc., of Long Beach, Calif., subsidiary of Roivant Sciences Ltd., of Basel, Switzerland Tapinarof Aryl hydrocarbon receptor modulator Plaque psoriasis Interim analysis showed 57.3% (298/520) who entered long-term open-label safety study, Psoaring 3, with PGA score ≥ 2 achieved PGA score of 0 or 1, suggesting increased therapeutic effect beyond 12-week treatment periods in pivotal Psoaring 1 and 2 studies; 39.2% (299/763) included in interim analysis achieved complete disease clearance (PGA score = 0); discontinuation rate at interim analysis due to adverse events was 5.8%, consistent with other pivotal trials


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