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Psychedelic Bulletin #143: Trademark Filing Reveals Potential Brand Name for MDMA; DEA “Open to Considering” Special Registration for Controlled Substances via Telemedicine; Professional Practice Guidelines for PAT; Sage’s Zuranolone Rejection

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atai Reports Q2 2023 Earnings and Provides Ibogaine Phase 1 Update

Yesterday, atai Life Sciences reported Q2 2023 financial results along with the first clinical data from DemeRx’s ibogaine (DMX-1002) candidate.

On the corporate side, atai had a cash position of $227.5 million as of June 30, 2023. When combined with a term loan facility, the company expects to be able to fund its operations through 1H 2026.

Contained within the business update were results from DemeRx’s Phase 1 study of DMX-1002 (N=20), its ibogaine candidate being developed for the treatment of opioid use disorder (OUD). Interestingly, the clinical trial registry entry explained that the single-ascending dose design would include four potential doses: 3, 6, 9, and 12 mg/kg. However, atai did not mention the 12 mg/kg dose in the present results, suggesting that it was not evaluated. One practitioner told Psychedelic Alpha that doses of >10 mg/kg are regularly given to individuals with substance use disorders in the unregulated space.

The company reports that treatment-related adverse events “were similar to those observed in prior trials of [ibogaine]”, adding that “nearly all (>94%) were rated mild-to-moderate in severity”. No serious adverse events were reported.

According to the press release, one of the two participants that received 9 mg/kg experienced QTc prolongation seen in other studies of ibogaine, though the company notes the patient “was asymptomatic, with no cardiac arrhythmias”. DemeRx worked “closely” with “cardiology experts” during the study. Those experts “concluded that while QT prolongation of this order is a clinical risk, monitoring can help mitigate the risk to ensure the safety of patients, especially in a medical setting.”

DemeRx “plans to engage regulatory authorities to assess progressing DMX-1002 into an efficacy study in patients with OUD.” It will be interesting to see whether the 9 mg/kg dose represents an upper limit for DemeRx in later-stage (efficacy-oriented) trials, at least until further safety testing is done in humans.


COMPASS Pathways’ Q2 2023 Earnings

Last week, COMPASS Pathways announced its Q2 2023 financial results and hosted a conference call, as is customary. At June 30, 2023, the company had a cash position of $148.2 million.

COMPASS’ Form 8-K also revealed that on July 26, 2023, atai Life Sciences exercised its right to demand registration rights for nearly 8 million CMPS shares. This type of registration rights allow an investor (in this case atai) to compel the company (in this case COMPASS) to file a registration statement, which would allow the investor to sell the shares into the public market. According to the Shareholder’s Agreement, COMPASS is required to file a resale registration statement within 45 days of that exercise.

Now, turning to the conference call. Commenting on the FDA’s draft guidance on clinical trials with psychedelic drugs (see Bulletin #140), COMPASS CMO Guy Goodwin said: “A particular note in the FDA guidance is the use of psychotherapy where the agency cautions such interventions may complicate the assessment of clinical trials.” He went on:

“I will note that COMP360 treatment is not designed to utilise psychotherapy but instead, psychological support, which primarily focuses on safeguarding patients”, he explained. “In fact, we think it is inappropriate to refer to psilocybin treatment as psychedelic-assisted psychotherapy as commonly occurs.”

“Regulators generally evaluate and approve investigational drug candidates based on quality, safety and efficacy. They have not historically evaluated or regulated psychotherapy. Our approach is clear to achieve regulatory approval, the drug effect needs to be established unambiguously in clinical trials, which is only possible with any psychological support is applied in a consistent way and is not an alternative treatment itself.”

As we noted in Bulletin #141 (and our 2022 Year in Review), COMPASS has sought—via a Commentary piece in the American Journal of Psychiatry and an associated press release—to further distance its self-described “psilocybin treatment” from “psilocybin-assisted psychotherapy”.

“Why might the use of the terms ‘psilocybin-assisted therapy’ or ‘psychedelic-assisted therapy’ move the authors to pen this article? …”

“COMPASS is gunning for FDA approval, but FDA’s remit doesn’t conventionally extend to psychotherapy. What’s more, FDA expects to see a submission that’s formed of ‘adequate and well-controlled’ studies. Given the much-discussed difficulties of expectancy effects and blinding challenges in psychedelic studies, it’s in COMPASS’ interest to present as if they are able to disaggregate or isolate the pharmacological effect as much as possible.”

As such, it wasn’t surprising to hear Goodwin toeing this particular line on the call, tying it in with the FDA’s draft guidance for good measure.


atai Announces PCN-101 IV-to-Subcutaneous Bridging Results

This week Perception Neuroscience, an atai subsidiary, announced results from its Phase 1 IV-to-subcutaneous (SQ) bridging study of its R-ketamine candidate, PCN-101.

The study, which enrolled 16 healthy participants, found that PCN-101 was generally well-tolerated via this administration route with no serious adverse events reported. “Encouragingly,” the company writes, “at the highest SQ dose of 120mg, rates of sedation … and dissociation … were each 14%.”

atai was keen to point out that the safety and tolerability profile “compares favorably to that of Spravato, for which rates of sedation and dissociation have been reported to be in the ranges of 50-61% and 61-69%”.

It’s not surprising that atai is looking to present its R-ketamine product as a potential alternative to Janssen’s esketamine product, Spravato. The product’s recent success was mentioned on COMPASS’ earnings call, too, when CEO Kabir Nath noted in his opening remarks that the esketamine product has “now achieved sales of $255 million for the first half of the year in the U.S. with quarter-over-quarter growth of roughly 30%”. atai will hope that SQ PCN-101 will be able to be taken at home, versus Spravato which is self-administered by the patient under the supervision of a healthcare provider.

But, it’s unlikely to be atai or Perception pushing things forward from here on out. The pair continue to work on exploring “strategic options”, the press release ends. (See our January analysis for a refresher on PCN-101’s ill-fated Phase 2a study.)

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