Confo Therapeutics NV is banking an up-front payment of $40 million from a licensing deal with Eli Lilly and Co. involving its lead asset, CFTX-1554, an oral inhibitor of the angiotensin II type 2 receptor, which is in phase I development for neuropathic pain. The deal includes up to $590 million more in potential milestones and tiered sales royalties. Ghent, Belgium-based Confo could also secure a further $590 million in additional milestones should Indianapolis-based Lilly elect to take forward an antibody-based inhibitor directed against the same target.
After a long and bumpy road to approval, Reata Pharmaceuticals Inc. is to roll out the first treatment for Friedreich’s ataxia in the U.S. for patients ages 16 and older after the FDA gave its anti-inflammatory drug, Skyclarys (omaveloxolone), the green light.
A shortage of efficacy compared to placebo in a phase II study of treating cognitive impairment has put Aptinyx Inc. on the defensive. The company’s oral, small-molecule NMDA receptor modulator, NYX-458, was being studied in 99 patients with mild cognitive impairment or mild dementia associated with Parkinson’s disease or Lewy body dementia. Based on the results, Aptinyx has decided to stop the therapy’s development, along with closing its phase IIb study of another oral, small molecule, NYX-783, for treating post-traumatic stress disorder.
In light of the growing interest in the use of psilocybin, MDMA and other psychedelics in psychotherapy, Health Canada issued a notice spelling out how licensed providers can obtain the drugs through the agency’s special access program on a case-by-case basis.
Transcend Therapeutics Inc. has closed on a series A funding of $40 million for its next-generation compound, methylone, an MDMA analogue, to be developed as a rapid-acting, disease-modifying, non-hallucinogenic treatment for neuropsychiatric conditions, including post-traumatic stress disorder.
Despite pleas from patient advocacy groups and bipartisan pressure from the U.S. Congress, the Centers for Medicare & Medicaid Services (CMS) isn’t budging on its national coverage determination for amyloid-targeting monoclonal antibodies approved to treat Alzheimer’s.
South Korean biotech peers Celltrion Healthcare Co. Ltd. and Liscure Biosciences Co. Ltd. signed a deal to co-develop microbiome-based oral live biotherapeutic products for Parkinson's disease. Under the agreement, Celltrion, of Incheon, South Korea, will provide Seoul-based Liscure with research funding as well as additional payments as the project progresses. Liscure will lead discovery of the novel candidates, and Celltrion will be responsible for further clinical and regulatory development.
Now that the U.S. FDA has granted accelerated approval for Biogen Inc./Eisai Co. Ltd.’s early Alzheimer’s drug, Leqembi (lecanemab), the Centers for Medicare & Medicaid Services (CMS) is being pressured to rethink its coverage of amyloid-targeting monoclonal antibodies.
The steadily percolating psychedelic drug space stands poised to generate a near-term stream of potentially encouraging developments in a range of mental health disorders, including depression, anxiety, post-traumatic stress disorder and more.
Psychedelic drugs may exert their effects at intracellular serotonin receptors that serotonin itself, which does not cross cell membranes, cannot reach. The findings were published in the Feb. 17, 2023, issue of Science by researchers from the University of California at Davis. An accompanying editorial by Evan Hess and Todd Gould at the University of Maryland School of Medicine called them “a key achievement in the understanding of the mechanism of action of psychedelics” and “an important step forward for a rapidly expanding and much-needed field of study.”
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