Ionis, Cyclerion tout positive data readouts; MAIA prices first biotech IPO in over two months
Ionis put out positive topline results from a Phase IIb trial on end-stage renal disease, investigating patients on dialysis.
The drug candidate, fesomersen, achieved its primary goal of “no increase in incidence of major bleeding and clinically relevant non-major bleeding,” compared to placebo. The study, named RE-THINC ESRD, was conducted by Bayer, which licensed the drug from Ionis.
Specific data will be presented at a later date at an undisclosed, upcoming medical meeting.
Ionis reported that the drug, developed as an antithrombotic, was safe and well-tolerated when administered monthly at 40 mg, 80 mg and 120 mg for up to 48 weeks. Fesomersen also showed statistically significant reductions in factor XI activity levels. Factor XI is a protein that plays a role in blood clotting.
“The results of the RE-THINC ESRD study demonstrate fesomersen’s potential as a novel anti-thrombotic treatment for cardiovascular and renal disease patients,” said Ionis SVP and CMO Sanjay Bhanot in a statement. — Paul Schloesser
Cyclerion says its drug showed cognitive effect in schizophrenia-related indication
Over at Cyclerion Therapeutics, the biotech said its drug showed promise in an early-stage study in patients with cognitive impairment associated with schizophrenia.
In the multiple-ascending dose study, the once-daily oral drug, dubbed CY6463, showed cognitive and inflammation effects after two weeks of dosing at 15 mg. The positive allosteric modulator led to an effect size of 0.60, compared to placebo, on the Cogstate Schizophrenia Battery cognition scale, the company reported, saying 0.3 is “generally considered clinically relevant in neuropsychiatry.”
The trial included 48 patients with stable schizophrenia on a “stable, single, atypical antipsychotic regimen.” The drug was safe and well-tolerated, Cyclerion said.
The higher doses of the drug did not have an effect on the general cognition composite at day 14, though. The results of the 30 mg and 60 mg dosing levels were “consistent with preclinical experiments,” Cyclerion said.
Cyclerion is also testing the drug in patients with Alzheimer’s with vascular pathology and patients with Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke-like episodes (MELAS). — Kyle LaHucik
MAIA Biotechnology prices at low end of range for its small IPO; opens on NYSE
Chicago biotech MAIA Biotechnology put out a statement Thursday setting its IPO price at $5 a share, and selling 2 million shares to gross $10 million in the raise. The range originally put out was $5-7 a share.
The company, specializing in targeted immunotherapies for cancer, added that underwriters will have 45 days to purchase an additional 300,000 shares at the offering price. It listed on the NYSE under the ticker $MAIA this morning, and the offering is expected to close Aug. 1.
The biotech added in an S-1 that it plans to use the funds from the offering to fund the first part of the Phase II trials of its product candidate THIO, a telomere targeting agent, in trials for NSCLC, CRC and other types of cancers that are telomerase-positive. On top of that, funding will go toward pre-clinical development of second-generation telomere targeting compounds and other undisclosed R&D.
Though small, MAIA’s IPO represents the first biotech debut in a couple months, per the Endpoints News tally. The last company to IPO was Okyo Pharma on May 17. — Paul Schloesser
Editor’s note: This story was updated to clarify that the higher doses of Cyclerion’s drug did not have an effect.