Aridis Pharmaceuticals Inc. has taken a few knocks in the past year but its new agreement with the U.S. FDA is giving it another opportunity to move forward. At midday, the company stock (NASDAQ:ARDS) had more than doubled to about 39 cents per share as the company and agency agreed on the design of the single confirmatory phase III superiority study of AR-301, an adjunctive therapy for treating pneumonia caused by gram-positive bacteria Staphylococcus aureus in mechanically ventilated hospitalized patients. Top-line results from the phase III AR-301-002 study in January showed an improvement in clinical cure rate of at least 10% with adjunctive use of AR-301 along with standard-of-care antibiotics. The big bump in the road has been Medimmune Ltd. pulling out of a 2021 licensing deal with Aridis in March, putting the AR-320-003 study of preventing ventilator acquired pneumonia on hold and prompting a 20% headcount reduction.

Zelira’s stock triples on cannabinoid outperforming Lyrica in head-to-head pain trial

Medicinal cannabis company Zelira Therapeutics Ltd.’s stock shot up 224% on May 31 on the heels of news that its cannabinoid product, ZLT-L-007, outperformed Lyrica (pregabalin, Pfizer Inc.) in a head-to-head trial in diabetic nerve pain. Top-line results showed that ZLT-L-007, a 1:1 tetrahydrocannabinol/cannabidiol combination product, achieved a significant reduction in Numerical Rating Scale (NRS) pain scores and was safe and well-tolerated. The company plans to progress the therapy to formal U.S. FDA clinical trials, said Zelira Chairman Osagie Imasogie, who noted that Lyrica has achieved peak annual sales of $5 billion per year, “clearly indicating the market potential for Zelira’s pain relief medication.” Zelira’s shares (ASX:ZLD) tripled on the news, climbing from AU94 cents on the previous day to close at AU$3.05 on May 31.

Signs of efficacy seen in Coave Therapeutics’ gene therapy trial in RP

Coave Therapeutics aims to move its lead gene therapy program, CTx-PDE6b, for a form of retinitis pigmentosa (RP) into a pivotal trial in 2025 on the back of a phase I/II study, which uncovered a preliminary efficacy signal in one patient subgroup. Before doing so, however, it aims to recruit onto the current protocol another six younger patients (aged 13–25 years) with early stage disease. The first subject is expected to undergo therapy in July, and the rest will follow within about nine months, CEO Rodolphe Clerval told BioWorld. The primary endpoint of the phase I/II study was safety. It recruited 17 patients in all, including 11 with advanced disease who were not expected to respond to the therapy. CTx-PDE6b, which employs an adeno-associated virus vector, is intended to preserve existing photoreceptor function but cannot regenerate those that have already been lost during the course of the disease.

Newco news: LTZ raises $10M in pre-series A round to advance lead immunotherapy 

Immunotherapy-focused biotech company LTZ Therapeutics Inc. raised more than $10 million in a pre-A+ financing that will be used to continue establishing the company’s platform and pipeline that is initially focused on solid and liquid tumors. Headquartered in Palo Alto, Calif., and with operations in Shenzhen, China, and Heidelberg, Germany, LTZ was founded in 2021 by three seasoned drug developers who held key leadership roles at Genentech Inc. The company has made significant progress, both scientifically and operationally, since it was established, LTZ co-founder and CEO Robert Li said. The fledgling company whose acronym stands for “Lift to Zenith,” is developing a three-tiered immunotherapy platform that is focused on reducing immunosuppression, reprogramming innate immunity and modulating adaptive immunity, Li told BioWorld.

Snipr’s Crispr-Cas bacteriophage kills resistant E. coli, offers new option for blood cancer

Snipr Biome ApS has published initial clinical data showing its Crispr-Cas modified bacteriophage product selectively kills Escherichia coli – including strains that are resistant to antibiotics – with no effect on the rest of the gut microbiome. That paves the way to test Snipr-001 in the prevention of bloodstream infections in hematological cancer patients who, as a result of increased intestinal permeability caused by chemotherapy, are at high risk of gut bacteria getting into the bloodstream. The data also provide proof of principle for treating other serious forms of E.coli bloodstream infections, and for the use of the platform technology to modify other wild-type phages to act against other bacterial infections. The results are a significant milestone in developing new approaches to treating antibiotic-resistant infections, said Christian Grøndahl, CEO and co-founder of Snipr.

Also in the news

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