Phase 1 Trial

VYNE Therapeutics Inc (NASDAQ: VYNE) announced positive efficacy results from the Phase 1b segment of Phase 1b/2a trial of FMX114 in mild-to-moderate atopic dermatitis (AD). Mean Atopic Dermatitis Severity Index (ADSI) scores for FMX114 and vehicle-treated lesions were 7.8 and 8.0,...

In its SEC filing, Seres Therapeutics Inc (NASDAQ: MCRB) disclosed it would not move forward with the planned SER-301 Phase 1b second study cohort. In its Q4 earnings release, Seres said that SER-301 was safe to proceed to the placebo-controlled second cohort in a Phase Ib trial...

VBI Vaccines Inc (NASDAQ: VBIV) announced updated clinical and preclinical data from its VBI-2900 coronavirus program, consisting of three candidates. VBI-2902 and VBI-2905, evaluated at a low dose of 5µg, were well-tolerated in clinical studies, with no safety signals...

Stealth BioTherapeutics Corp (NASDAQ: MITO) announced the presentation of new SBT-272 preclinical data and dosing of the first subject in its Phase 1 trial of SBT-272. The new data demonstrated behavioral and metabolic improvements with SBT-272 in a mouse model of Huntington's...

Portage Biotech Inc (NASDAQ: PRTG) has updated its clinical development programs and announced its development goals for 2022, and it continues to work toward multiple clinical readouts in 2022. In 2021, clinical trials for Portage's lead invariant natural killer T cell (iNKT) agonist...

Longeveron Inc (NASDAQ: LGVN) announced the publication of Phase 1 trial results of Lomecel-B on patients with mild Alzheimer's disease (AD) in the Alzheimer's & Dementia journal. The 33-subject trial met its primary endpoint, demonstrating that Lomecel-B was well...

CureVac N.V. (NASDAQ: CVAC) dosed the first participant in a Phase 1 study of COVID-19 second-generation mRNA vaccine candidate, CV2CoV, developed with GlaxoSmithKline plc (NYSE: GSK).  The clinical trial is expected to provide valuable data to evaluate further the...

Synthetic Biologics Inc (NYSE: SYN) announced the peer-reviewed publication of the Phase 1 study investigating intravenous VCN-01 oncolytic adenovirus with or without standard-of-care (SoC) chemotherapy in advanced solid tumors.  The data, published in the ...

Biogen Inc (NASDAQ: BIIB) and Ionis Pharmaceuticals Inc (NASDAQ: IONS) have announced topline results from the Phase 1 study of BIIB078 (IONIS-C9Rx) for C9orf72-associated amyotrophic lateral sclerosis (ALS). In this Phase 1 study, BIIB078 was generally well-tolerated. The...

Pluristem Therapeutics Inc (NASDAQ: PSTI) announced final results from its hematology Phase 1 study of intramuscular injections of PLX-R18 in subjects with incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). Data collated 12 months post-treatment...

Aligos Therapeutics Inc (NASDAQ: ALGS) has discontinued the development of its drug candidate, ALG-020572, which was being studied in subjects with chronic hepatitis B (CHB).  Dosing in the first CHB cohort of the Phase 1 study was stopped after one subject experienced a...

ORIC Pharmaceuticals Inc (NASDAQ: ORIC) has decided to discontinue the further development of ORIC-101 after interim analyses from the two Phase 1b studies, wherein ORIC-101 did not demonstrate sufficient clinical activity. The dose-expansion portion of the Phase 1b trial of ORIC-...

Terns Pharmaceuticals Inc (NASDAQ: TERN) reported topline results from Part 1 of Phase 1b AVIATION Trial of TERN-201 for treating patients with non-alcoholic steatohepatitis (NASH).   Part 1 of the AVIATION Trial met the primary safety endpoint. Compared to placebo, 10 mg...

Pulmatrix Inc (NASDAQ: PULM) announced topline results of its recently completed Phase 1b clinical study of PUR1800 in patients with stable Chronic Obstructive Pulmonary Disease (COPD). PUR1800 is a narrow spectrum kinase inhibitor (NSKI) administered as a dry powder for inhalation...

KemPharm Inc (NASDAQ: KMPH) completed its analysis of the full data set from its Phase 1 clinical trial of serdexmethylphenidate (SDX) delivered at doses higher than those previously studied.  SDX, KemPharm's proprietary prodrug of d-methylphenidate (d-MPH), is the sole...