Month: September 2022

Sight Sciences Announces Completion of Enrollment in SAHARA, a Randomized Clinical Trial of the TearCare® System vs Restasis®

09/27/2022

310-patient RCT designed to evaluate the superiority of TearCare® (device) vs Restasis® (drug) in patients with chronic dry eye disease is now fully enrolled 6-Month efficacy results expected by Summer 2023 Excerpt from the Press Release: MENLO PARK, Calif., Sept. 13, 2022 (GLOBE NEWSWIRE) — Sight Sciences, Inc. (Nasdaq: SGHT), an eyecare technology company focused…

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Sagimet Biosciences Announces Completion of Patient Enrollment in Phase 2b ‘FASCINATE-2’ Clinical Trial with Denifanstat (TVB-2640), a First-in-Class Fatty Acid Synthase Inhibitor, in Non-alcoholic Steatohepatitis

09/27/2022

Excerpt from the Press Release: SAN MATEO, Calif.–(BUSINESS WIRE)–Sagimet Biosciences, a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic pathways, announced today that it has completed enrollment of its Phase 2b liver biopsy-based clinical trial (“FASCINATE-2”) with denifanstat, a fatty acid synthase (FASN) inhibitor, in non-alcoholic steatohepatitis (NASH) patients. “Completing patient enrollment in the…

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Nura Bio Reports Preclinical Data Validating a Conserved Mechanism of Inhibition of NAD Hydrolases Implicated in Neurodegeneration in Neuron

09/26/2022

– Potent, uncompetitive inhibitors of the pro-degenerative NADase SARM1 reported – Molecular basis of product-assisted inhibition of NAD hydrolases like SARM1 and CD38 that have been implicated in neurological diseases elucidated – Research supports Nura Bio’s goal of entering First-in-Human trials with oral, brain-penetrant SARM1 inhibitors in early 2023 Excerpt from the Press Release: SOUTH…

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Mereo BioPharma Reports Clinical Update and Interim Biomarker Analysis Presented at ESMO 2022 from ACTIVATE Phase 1b/2 Open Label Study of Etigilimab (Anti-TIGIT Antibody MPH-313) plus Nivolumab (Anti-PD-1 Antibody) in Solid Tumors

09/26/2022

Data support further evaluation of PVR, CD226, and TIGIT as potential biomarkers of enrichment for etigilimab plus anti-PD1 therapy Continued clinical benefit observed with the combination of etigilimab and nivolumab, including in PD-L1 negative or low subjects Excerpt from the Press Release: LONDON and MOUNTAIN VIEW, Calif., Sept. 12, 2022 (GLOBE NEWSWIRE) — Mereo BioPharma…

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In Akero Therapeutics’ Phase 2b HARMONY Study, Both the 50mg and 28mg EFX Doses Achieved Statistical Significance on Primary and Secondary Histology Endpoints after 24 Weeks

09/26/2022

50mg (41%) and 28mg (39%) groups demonstrated ≥1 stage improvement in fibrosis without worsening of NASH, double the placebo rate (20%) 50mg (76%) and 28mg (47%) groups demonstrated NASH resolution without worsening of fibrosis, three to five times the placebo rate (15%) 50mg (41%) and 28mg (29%) groups demonstrated fibrosis improvement AND resolution of NASH,…

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Join Christopher Kata in San Diego for the “IN”novation Mixer Networking Event on September 28th!

09/25/2022

We’re extending this special invitation to our “IN”novation Mixer event, hosted by TrialStat Solutions, Avance Clinical, Science Media and Life Sciences Marketplace on Wednesday, September 28th, starting at 5 pm PT at The Winery Restaurant and Wine Bar, located in the UTC Westfield Plaza at 4301 La Jolla Village Dr Ste 2040, San Diego, CA 92122. Please join Christopher Kata, and a select…

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Excision BioTherapeutics Doses First Participant in EBT-101 Phase 1/2 Trial Evaluating EBT-101 as a Potential Cure for HIV

09/23/2022

EBT-101 is an in vivo CRISPR-based therapeutic designed to remove HIV proviral DNA from affected cell reservoirs First-in-human study will evaluate the safety and efficacy of EBT-101 in participants who chronically suppress HIV with daily antiretroviral therapy EBT-101 has been well tolerated to-date and the trial is proceeding as planned Excerpt from the Press Release:…

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BioJiva Reports Results of Pilot Phase 2 Clinical Trial of RT001 in Patients with Amyotrophic Lateral Sclerosis (ALS)

09/23/2022

Signals of Clinical Benefit Detected in Small Phase 2 Study, Suggesting Potential to Show Statistically Significant Therapeutic Benefit in Larger, Targeted Trial Consistent Benefit vs. Placebo in Primary and Secondary Endpoints, With Greater Benefit Witnessed in More Severe Patients Excerpt from the Press Release: LOS ALTOS, Calif., Sept. 15, 2022 (GLOBE NEWSWIRE) — BioJiva, a…

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Celsion Completes Enrollment of the Phase I/II OVATION 2 Study with GEN-1 in Advanced Ovarian Cancer

09/23/2022

110 Patients Enrolled in Study Comparing Novel Gene-Mediated Immunotherapy plus Neoadjuvant Chemotherapy versus Neoadjuvant Chemotherapy Alone Excerpt from the Press Release: LAWRENCEVILLE, N.J., Sept. 15, 2022 (GLOBE NEWSWIRE) — Celsion Corporation (NASDAQ: CLSN), a clinical-stage company focused on DNA-based immunotherapy and next-generation vaccines, today announced that its Phase I/II OVATION 2 Study with GEN-1 in advanced…

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Danicopan (ALXN2040) Add-On to ULTOMIRIS® (ravulizumab-cwvz) or SOLIRIS® (eculizumab) Met Primary Endpoint in ALPHA Phase III Trial for Patients with Paroxysmal Nocturnal Hemoglobinuria Who Experience Clinically Significant Extravascular Hemolysis

09/22/2022

Interim results demonstrate statistically significant improvement compared to placebo in hemoglobin levels from baseline to week 12 Excerpt from the Press Release: WILMINGTON, Del.–(BUSINESS WIRE)–A prespecified interim analysis of the ALPHA Phase III trial evaluating danicopan (ALXN2040), an investigational, oral factor D inhibitor, as an add-on to C5 inhibitor therapy ULTOMIRIS® (ravulizumab-cwvz) or SOLIRIS® (eculizumab)…

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