Citius Pharmaceuticals Inc.’s retooled version of withdrawn cancer drug Ontak (denileukin diftitox) is not quite ready for prime time, according to the U.S. FDA, which issued a complete response letter (CRL) for the interleukin-2-diphtheria toxin fusion protein known as Lymphir. The agency is asking for Citius to incorporate enhanced product testing and additional controls but did not raise any concerns regarding safety and efficacy, the company said.

Sumitomo/Otsuka’s ulotaront misses phase III endpoints in schizophrenia

Top-line results show a disappointing placebo effect that resulted in Sumitomo Pharma Co. Ltd./Otsuka Pharmaceutical Co. Ltd.’s ulotaront (SEP-363856) missing the primary endpoints in both the Diamond (Developing Innovative Approaches for Mental Disorders) 1 and Diamond 2 trials in schizophrenia. A trace amine-associated receptor 1 (TAAR1) agonist with 5-HT1A agonist activity, ulotaront was dosed once daily in acutely psychotic adults living with schizophrenia. “Sumitomo Pharma and our collaborator Otsuka Pharmaceutical have done preliminary analyses of the data and we believe that a high placebo response may have masked the therapeutic effect of this innovative molecule,” Sumitomo Pharma CEO Hiroshi Nomura said.

Powerful phase II data helps Mymd stock surge

Mymd Pharmaceuticals Inc.’s stock rallied in early trading on top-line phase II results from its phase II study of MYMD-1 for treating sarcopenia but had settled a few hours later. The company’s shares (NASDQ:MYMD) still were getting a solid bump at midday though as they traded 12% upward to $1.23 each. The oral TNF-α inhibitor powered the study to meet its primary endpoints of significantly reducing chronic inflammatory markers in patients with chronic inflammation associated with age-related frailty. The study also hit all its secondary endpoints regarding safety and tolerability. There were no treatment-related adverse events or serious adverse events during the study.

Hanmi repositions once-returned GLP-1 drug to obesity

South Korean pharmaceutical company Hanmi Pharmaceutical Co. Ltd. may have found its footing after its misstep with Sanofi SA in 2020 for efpeglenatide, its glucagon-like peptide-1 (GLP-1) receptor agonist. On July 31, Hanmi announced that the once-dropped drug would be developed to treat obesity in the Korean population, submitting an IND application to the MFDS on July 28 to examine the once-a-week injection efpeglenatide in a phase III trial. The domestic phase III study will benchmark standards set by the Korean Society for the Study of Obesity, which defines obesity as a body mass index of 25 kg/m² or higher.

Galectin developers casting wide net in clinical development

The galectin pathway has proven increasingly alluring to drug developers taking aim at conditions as varied as cancer, liver fibrosis and Alzheimer’s disease. In late May, Galecto Therapeutics Inc. dosed the last patient in its Galectic-1 phase IIb trial with the Boston firm’s most advanced product candidate: inhaled, once-daily GB-0139 for idiopathic pulmonary fibrosis. Other players include Galectin Therapeutics Inc., Puretech Health plc and Truebinding Inc.

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