The previous head of clinical improvement and investigation at Athira Pharma criticized the company’s handling of an investigation that led to the resignation of longtime CEO Leen Kawas in October.
Xue Ha released a blog site submit Tuesday describing her departure from the Seattle-place biotech enterprise. Ha first joined Athira in 2015 from the College of Southern California, the place she was an assistant professor of neurology.
“I still left Athira in February 2022, as I strongly disagree with the Board’s decision to dismiss Leen Kawas as the CEO, the rationale Athira presented to the general public to purportedly justify her dismissal, and the deficiency of transition that resulted in rising leadership gaps,” she wrote.
Kawas resigned and departed the board following an impartial specific committee concluded that she experienced altered details-made up of illustrations or photos in scientific papers as a graduate pupil. Individuals papers were central to the founding of the Bothell, Clean.-primarily based neurosciences enterprise, then termed M3 Biotechnology, in 2011.
“In my feeling, the managing of Athira’s investigation pertaining to Leen Kawas and her subsequent dismissal fell under what scientific ethics named for and raises many unanswered thoughts,” Ha said in the put up.
Reached through e mail, Kawas declined to remark on Ha’s write-up. GeekWire reached out to Athira for comment and we’ll update when we hear back again.
The publish is the hottest addition to ongoing drama at Athira, which this 7 days was hit with an additional lawsuit submitted by a shareholder accusing the company of withholding information about the graphic alteration in advance of Athira’s IPO in 2020. Athira is struggling with related lawsuits from other shareholders.
Ha claimed the graphic manipulation was disclosed to the board in 2015, and that a new enterprise presentation on its scientific prospect for neurological condition did not appropriately attribute Kawas. Ha has retained documents from the company related to creation and authorship, she reported.
Athira is accomplishing 4 clinical trials on a compound named fosgonimeton (also identified as ATH-1017) for neurological ailments, which include Alzheimer’s disorder. But the company has not nevertheless posted its preclinical findings on that compound in a peer-reviewed journal. The company’s data, reported Ha, demonstrate that fundamental conclusions of Kawas’ graduate do the job on a similar compound are valid.
The organization produced its preclinical facts on fosgonimeton in a presentation at a convention in March.
Ha also criticizes the board for distancing the firm from Kawas’ initial papers. For instance, she pointed out that company’s current annual report with the SEC said, “the carry out that was the subject of the allegations is not associated to any of our existing products candidates or ongoing scientific investigate.”
Ha disagrees with that characterization. She notes that Kawas’ unique papers assessed a compound very comparable to fosgonimenton, called dihexa. Fosgonimeton is a “prodrug” of dihexa, which means that it breaks down in the overall body into dihexa. Dihexa “is not only linked to fosgonimeton it is the core active drug that provides the therapeutic potential.”
By stating that Kawas’ analysis is not associated to the company’s current applicant, the organization also is not offering correct attribution, claimed Ha.
In its place of pushing Kawas out of the corporation, Athira really should have proven the scientific validity of dihexa and “integrity of the prior analysis,” Ha mentioned.
“Doing so would not only have been the ideal issue to do, but it also would have avoided the expensive and disruptive ousting of the CEO,” mentioned Ha in her publish.
Ha explained “none of the inventors of dihexa” were being detailed as co-authors on the new conference presentation. Kawas’ title was not detailed, nor was that of her advisor at Washington Point out University, fellow co-founder Joseph Harding.
In her post, Ha reported that she has an “ongoing dispute” with Athira because she retained files from the firm. “I noticed how Leen’s authorship was dealt with and the inventorship was managed, I retained files to help the contributions,” she additional in an e-mail.
Ha is 1 of numerous of Kawas’ associates to weigh in with support. In April, Harding wrote a letter on LinkedIn praising her do the job as a graduate student and CEO. He wrote that he elevated the problem of details “embellishment” by Kawas with then-board chair John Fluke and other folks in the organization, when he very first realized about it in 2015.
Ha additional in her submit: “Leen Kawas designed a miscalculation in excess of 10 decades back as a younger and inexperienced graduate student. She acknowledged and preset her oversight with the assistance of her advisor and colleagues to the ideal extent probable, with proper disclosure to the college, Athira board, and other crucial stakeholders much more than five decades in the past.”
Kawas has due to the fact co-launched an financial investment organization with an additional supporter, Athira trader Richard Kayne. Kayne has criticized the board for changing Kawas and has released an work to switch the recent CEO, Mark Litton, with the previous chief professional medical officer of GlaxoSmithKline, Ronald Krall.
Athira is envisioned to report early knowledge on a period 2 medical demo for fosgonimeton this quarter.