Company Product Description Indication Status
Phase I
Athira Pharma Inc., of Seattle NDX-1017 Small-molecule therapeutic designed to enhance activity of hepatocyte growth factor and its receptor, MET Alzheimer's disease NDX-1017 showed dose-dependent and consistent changes in brain activity across all treated cohorts
BJ Bioscience Inc., of Hangzhou, China BJ-001 IL-15 fusion protein Cancer cells that overexpress integrins such as αvβ3, αvβ5, and αvβ6  First patient dosed
Cerevel Therapeutics Inc., of Boston CVL-865 Alpha 2/3/5-subtype GABAA positive allosteric modulator Epilepsy Observed to be rapidly absorbed and well-tolerated in healthy volunteers
Cortexyme Inc., of South San Francisco COR-388 Small-molecule gingipain inhibitor Alzheimer's disease After 28 days, a statistically significant decrease in ApoE fragments (both ApoE4 and ApoE3) was observed in subjects treated with drug vs. those treated with placebo
Eagle Pharmaceuticals Inc., of Woodcliff Lake, N.J. Fulvestrant Estrogen receptor antagonist Hormone-related breast cancer Dosing begun in pilot study
Ico Therapeutics Inc., of Vancouver, British Columbia Oral amphotericin B Antifungal Vulvovaginal candidiasis First 2 cohorts received the first dose
Immunocore Ltd., of Oxfordshire, U.K. IMC-C103C T-cell redirecting bispecific biologic MAGE-A4-expressing cancers First patient dosed
Nouscom GmbH, of Basel, Switzerland NOUS-209 Off-the-shelf therapeutic vaccine based on shared tumor neoantigens Microsatellite instable high gastric, colorectal and gastroesophageal junction cancers  First patient dosed
Sage Therapeutics Inc., of Cambridge, Mass. SAGE-718 Oxysterol-based positive allosteric modulator of N-methyl-D-aspartate receptor Huntington’s disease Drug was well-tolerated in patients and healthy volunteers; in patients, drug improved performance compared to baseline on assessments of executive functioning; patient data to be presented in 2020; plans to move drug into phase II development
Syndax Pharmaceuticals Inc., of Waltham, Mass. SNDX-6352 Anti-CSF-1R monoclonal antibody Chronic graft-vs.-host disease Both evaluable patients treated at the highest dose of 1 mg/kg had a partial response as did the 1 patient treated at 0.5 mg/kg; cohort testing 3 mg/kg is open; plans to advance into a phase II expansion cohort at 1 mg/kg in first quarter of 2020
Vaccinex Inc., of Rochester, N.Y. Pepinemab Humanized monoclonal antibody that binds and blocks the signaling activity of semaphorin 4D  Neurodegenerative disease Presented evidence suggesting the drug prevents transformation of brain glial cells from their normal supportive activities to inflammation
Vedanta Biosciences Inc., of Cambridge, Mass. VE-800 Rationally defined bacterial consortium of 11 commensal strains that activate cytotoxic CD8+ T cells Selected types of advanced or metastatic cancer Study begun in combination with Opdivo (nivolumab, Bristol-Myers Squibb Co.)
Phase III
Eisai Inc., of Woodcliff Lake, N.J.  Fycompa (perampanel) AMPA glutamate receptor antagonist Partial-onset seizures In the 91-patient Freedom study, seizure freedom rates at 26 weeks were 64.6% and 77% for 4-mg dose and combined 4 mg plus 8 mg, respectively; in the 85-patient Fame study, after a 24-week maintenance period, 50% responder rate was 80%, 75% responder rate was 71.8% and seizure freedom rate was 47% by adjunctive anti-epileptic drug use
Moberg Pharma AB, of Stockholm MOB-015 (topical terbinafine) Squalene epoxidase inhibitor Mild to moderate toenail onychomycosis At 52 weeks, 4.5% of patients treated with drug achieved a complete cure compared to 0% of those receiving vehicle (p=0.019); 70% of patients treated with drug achieved a mycological cure, defined as both negative KOH and negative dermatophyte culture (p<0.0001); 15.4% of patients treated with drug achieved treatment success, defined as mycological cure and almost or completely clear great toenail (p= 0.0018)
Supernus Pharmaceuticals Inc., of Rockville, Md. SPN-810 5-HT2B receptor antagonist Impulsive aggression in attention deficit hyperactivity disorder Additional analysis of P301 study showed excluding patients with a baseline score of 6 episodes or less per week resulted in a median percent reduction of 59.2% in the average weekly frequency of impulsive aggression episodes from baseline (p=0.017)
Tonix Pharmaceuticals Holding Corp., of New York TNX-102 SL (cyclobenzaprine HCl sublingual tablets) Analgesic Fibromyalgia Enrolled first of approximately 470 patients in the Relief study measuring daily diary pain severity score change from baseline to week 14
Phase IV
Eisai Inc., of Woodcliff Lake, N.J.  Fycompa (perampanel) AMPA glutamate receptor antagonist Epilepsy  In the real-world Prove study, 48% of 1,042 patients remained on treatment after 24 months and 39.2% of patients were seizure free during months 22-24

Notes

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

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