Incannex Healthcare, Inc.

Plus, news about Chai Discovery, Relay Therapeutics, Incannex Healthcare, PhoreMost, Epsilogen and LIFTT: Ionis prices $500M offering: The veteran RNA biotech is offering 11.5 million shares $IONS at $43.50 apiece, almost $5.00 below Monday’s closing price. The Carlsbad, CA-based drugmaker has long relied on partners to commercialize its medicines but is attempting to launch its own treatments, with multiple late-stage programs in the works. The FDA is set to decide whether to approve Ionis’ olezarsen in familial chylomicronemia syndrome by Dec. 19. Terns Pharmaceuticals eyes $125M offering: The same day that it shared positive data for its oral GLP-1 , the biotech said it would seek $125 million in a public offering. OpenAI invests in drug discovery: The ChatGPT maker is joining Thrive Capital and Dimension Capital to back Chai Discovery, which raised a total of $30 million, according to Bloomberg . The startup, which was founded less than a year ago, is using machine learning to predict biochemical molecule structures and unveiled its first open-source model. Relay Therapeutics also tees up offering: After sharing early-stage breast cancer data on Monday morning, Relay went to investors with a $200 million public offering. Incannex Healthcare forges up to $60M in financing: The funding , which comes from Arena Investors, will help the chronic disease biotech as it works on clinical trials across sleep apnea, generalized anxiety disorder and rheumatoid arthritis. PhoreMost adds $12M to Series B: The Cambridge, UK-based startup previously closed the round in 2021. The total raise now surpasses $50 million . It’s working on new degraders in oncology and inflammatory diseases. Epsilogen extends Series B with £12.5M: The London-based startup originally raised £30.75 million for the round in 2022. The new funding is expected to help fuel a proof-of-concept trial in platinum-resistant ovarian cancer. The European Investment Bank and Italian VC firm LIFTT are jointly contributing to a €100M venture that will back 20 to 30 startups, including those in life sciences.

The psychedelic drug field hit a setback this month when the Food and Drug Administration rejected Lykos Therapeutics application for approval of an MDMA-assisted therapy.The rejection was not entirely unexpected, after advisers to the FDA had recommended against approval for several reasons, including concerns over drug abuse, alleged sexual misconduct during testing and Lykos failure to collect certain data the FDA requested.While an approval would have been a notable milestone, Lykos disappointment could still prove instructive to other biotechnology companies advancing their own psychedelic therapies.The FDAs decision has put the sector on notice that [the agency] will not accept any short cuts, said Doug Drysdale, CEO of Cybin, a biotech with several psychedelic therapies in the clinic. While the decision may be impacting psychedelic stocks in the near term, long term we expect FDA rigor to result in more robust studies and outcomes for patients.Lykos lessons?In its August decision, the FDA issued Lykos a complete response letter for its MDMA capsules for people with post-traumatic stress disorder, requesting the company conduct another Phase 3 trial. Lykos said at the time that it planned to request a meeting with the FDA to reconsider the decision and seek recommendations for a resubmission.However, in the weeks following, Lykos revealed plans to lay off 75% of its staff as part of a reorganization before it resubmits an application. The company also recruited David Hough, a former vice president of R&D at Johnshon & Jonhson who helped develop the approved esketamine spray Spravato, to oversee clinical work and FDA engagement.Other biotechs advancing psychedelic compounds, such as MDMA, ketamine, LSD or psilocybin, are similarly targeting PTSD, depression, anxiety and other mental health disorders. And those companies with therapies in mid- and late-stage studies have been taking notes on Lykos rejection.Cybin is preparing to begin Phase 3 testing for its psilocybin-related drug CYB003 in people with major depressive disorder. Cybin completed a meeting with the FDA this month to finish the design of a study thats slated to begin in late summer 2024.Both FDA staff and advisers had flagged issues with functional unblinding in Lykos testing of MDMA-assisted therapy. The effect, which describes how patients can guess their treatment assignment based on their reaction to the drug, remains a key challenge for testing psychoactive substances.Cybin has attempted to design its study to prevent such unblinding. By using a three-arm design with a high dose, mid-dose and placebo arm, participants may be less likely to guess if they received a therapeutic or sub-therapeutic dose. Like Lykos did in its tests, Cybin is also using remote raters to mitigate the risks of unblinding.Still, the rejection may be specific to Lykos rather than representative of the outlook for the entire psychedelic field.During our interactions with the FDA we have received invaluable guidance on the design of our Phase 3 depression program, said Drysdale, of Cybin. From a regulatory perspective, we believe that we have a clear roadmap ahead and that the Lykos issues were very much specific to the quality of their [application], rather than a category issue.More data aheadFollowing behind Lykos are a cluster of biotechs, Cybin among them, that have medicines in mid- to late-stage testing.Compass Pathways is furthest along in clinical trials with a psilocybin treatment, dubbed COMP360, that it is evaluating for treatment-resistant depression, PTSD and anorexia nervosa. In May, the company announced topline results from its Phase 2 study of the drug in PTSD patients, showing improvements on scales rating symptoms of the condition. Compass expects to reveal topline data from its Phase 3 study of COMP360 in treatment-resistant depression during the fourth quarter.Australia-based Incannex Healthcare is developing psilocybin-assisted psychotherapy to treat generalized anxiety disorder, and will soon begin Phase 2b testing. The company released topline results from a Phase 2 trial earlier this year.MindMed, a biotech studying LSD as a treatment for generalized anxiety disorder, also completed a meeting with the FDA in June as it works to finalize its Phase 3 trial design. The company also plans to use tiered dosing.We are on schedule to initiate our Phase 3 clinical program for MM120 oral dissolving tablet in GAD in the second half of this year and look forward to sharing additional details on the design of our pivotal program in the coming months, MindMed CEO Rob Barrow said in June. '

Pictured: Man sitting on a bed looking stressed/iStock, pcess609 Lykos Therapeutics’ investigational midomafetamine capsules, which the biotech is proposing as a treatment for post-traumatic stress disorder, is slated to come under the scrutiny of the FDA’s Psychopharmacologic Drugs Advisory Committee. The meeting of external experts, which is scheduled for June 4, 2024, will be the first advisory committee session convened for a potential new post-traumatic stress disorder (PTSD) therapy in 25 years, according to the biotech’s press release. Lykos’ drug application will also be the “first MDMA-assisted therapy and psychedelic-assisted therapy to be reviewed by the Psychopharmacologic Drugs Advisory Committee,” CEO Amy Emerson said in a statement, calling the meeting and the investigational therapy a “significant milestone in the field of psychedelic medicine.” MDMA, scientifically known as 3,4-methylenedioxymethamphetamine but colloquially called ecstasy—belongs to a class of psychoactive compounds called entactogens, which have the effect of increasing their users’ self-awareness and introspection. MDMA is a Schedule I drug, limiting its recreational and medical use. Lykos is proposing to use MDMA tablets, in conjunction with psychotherapy and other supportive mental health services, as a treatment for adults with PTSD. Its New Drug Application, which the FDA accepted in February 2024, is backed by data from several studies including the Phase III MAPP1 and MAPP2 trials. Both late-stage trials evaluated the Lykos’ MDMA-assisted therapy using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), the gold standard in PTSD symptom assessment. Key secondary endpoints for both trials also included functional improvement. Results from MAPP1, which focused on patients with severe PTSD, showed a “significant and robust attenuation” in CAPS-5 scores versus placebo, according to a 2021 publication in Nature Medicine. The MDMA-assisted regimen also led to a significant improvement on the Sheehan Disability Scale, which quantifies functional ability. MAPP2, which enrolled patients with moderate-to-severe disease, showed similar outcomes. CAPS-5 scores improved significantly compared to placebo, as did patients’ functional performance. Both studies also revealed an overall favorable tolerability pro the MDMA-assisted therapy, with no deaths and serious adverse events associated with the investigational treatment. The FDA’s verdict is due on August 11, 2024. Lykos’ adcomm meeting comes as psychedelics are poised to break into the biopharma industry’s mainstream. Last week, Novo-backed Reunion Neuroscience raised $103 million in a Series A financing round to advance its psilocybin-derivate therapy RE104 for postpartum depression. In March 2024, MindMed’s LSD-based treatment MM120 (lysergide d-tartrate) won the FDA’s breakthrough designation on the back of positive Phase IIb data. A few weeks earlier, Incannex also reported strong Phase II data for its investigational psychedelic psilocybin drug candidate in generalized anxiety disorder. In January 2024, the MAPS Public Benefit Corporation rebranded as Lykos Therapeutics after raising $100 million in a Series A. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.