Lusaris Raises $60m to Develop 5-MeO-DMT

GH Research’s lead investor incubates its own 5-MeO-DMT company: Lusaris Therapeutics has emerged from stealth with a $60m Series A round, led by RA Capital, to propel sublingual 5-MeO-DMT formulation through trials.

The company’s lead candidate, LSR-1019, is a sublingual formulation of 5-MeO-DMT for treatment-resistant depression (TRD) and other neuropsychiatric indications. As such, this marks the second significant investment in the molecule by RA Capital, which incubated Lusaris and led the Series A. Their first was GH Research…

What’s Going on at GH Research?

A year and a half ago, RA Capital co-led Dublin-based GH Research’s $125m Series B financing to support the clinical development of inhaled 5-MeO-DMT (GH001) in TRD, among other conditions. Venrock and Boxer Capital also participated in this round, as well as Lusaris’ recent Series A. All that to say: there’s a clear interest in this particular molecule from this group of established healthcare and life sciences investors.

With around $250m cash on hand, GH Research has a runway that will likely take them into 2025. Despite having the largest marketcap among public psychedelics companies and one of the largest cash piles, many are wondering whether GH’s progress is on course.

According to the company’s latest filings it spent $4.2m on R&D in Q2 and $2.5m on G&A. Compare this with some comps: Small Pharma (which has just over a tenth of the cash on hand of GH) spent $2.7m, while COMPASS Pathways (which has around $170m cash on hand) spent $14m on R&D in its most recent filed quarter.

The Phase 2 part of GH’s Phase 1/2 trial out of Maastricht enrolled just 8 patients to receive the inhalable 5-MeO-DMT formulation. While results were impressive, with 7 of the 8 TRD patients in remission 7 days after dosing, such a small sample size and lack of placebo control dampens the utility of such findings.

GH Research is a tight-lipped company, but filings and clinical trial registry entries show that it was planning to submit clinical trial applications for an 80 patient Phase 2b of GH001 in a number of European countries this past quarter. Elsewhere, the company initiated two proof-of-concept Phase 2a studies of GH001 in Bipolar II Disorder and Post-partum Depression. GH also planned to submit an IND with the FDA for GH001 in TRD by Q1 2023, which would lead to a Phase 1 imaging study.

One thing to know about GH001 is that it employs an individualised dosing regimen, which is seen by some as complicated; especially when combined with the inhalation delivery mechanism which entails the use of a Volcano vaporiser and balloon.

It’s most likely, in this author’s opinion, that RA Capital thought a less convoluted dosing regimen would be beneficial: say, one dose via a sublingual tablet. This wrinkle in GH’s program was presumably what led RA to incubate Lusaris, though it’s unclear why this couldn’t have been integrated into GH’s operation.

Indeed, while Lusaris avoided our question of how they’re differentiated from their fellow RA Capital-backed GH Research, their response hinted that issues with the drug delivery system might indeed be the reason for the company’s new direction in that regard. “[Lusaris’] approach is scalable, eliminates the need for burdensome drug delivery systems, simplifies administration, and offers the potential for more consistent exposure and more predictable therapeutic benefit in patients,” the company told Psychedelic Alpha.

Lusaris Scores Exclusive Licence for Zydis Orally Disintegrating Tablet Tech

Alongside its Series A announcement, Lusaris revealed that it has secured an exclusive worldwide licence to Catalent’s Zydis orally disintegrating tablet tech. Lusaris isn’t the first psychedelics company to strike up a deal with Catalent for this popular drug delivery method: both Cybin and Awakn have entered into drug development agreements with the company (a point that Awakn was keen to emphasise in an investor communication following Lusaris’ news).

Note, however, that Lusaris has been granted an exclusive licence to use Catalent’s Zydis tablet tech, which is much more significant than the other two drug developers’ drug development agreements, which generally entail feasibility studies at this stage. Lusaris told Psychedelic Alpha that the licence “covers the molecule 5-MeO-DMT in the Zydis platform for all related formulations and indications.” This would presumably prevent companies like GH Research from piggy-backing on the Zydis drug delivery mechanism.

Lusaris expects to initiate Phase 1 clinical studies of LSR-1019 imminently, with a readout in mid-2023. The company is also building a portfolio of novel serotonergic neuroplastogens for a range of conditions including migraine and cluster headache, according to the press release.

Others Trialling the Toad

A number of other groups are exploring 5-MeO-DMT, including Beckley Psytech and Alvarius Pharmaceuticals.

For its part, Beckley dosed its first healthy volunteers in its Phase 1 trial of a dry powder intranasal spray formulation of 5-MeO-DMT (BPL-003) in Spring this year. The study, which took place at King’s College London and enrolled 36 patients (of the 52 anticipated), was completed in early July. The company announced BPL-003 as its lead candidate for upcoming Phase 2 studies in depression and alcohol use disorder, where the intranasal 5-MeO-DMT is delivered in combination with psychotherapy.

Alvarius Pharmaceuticals, meanwhile, was funded by Christian Angermayer’s Re:Mind Capital back in early 2021 when it secured EUR 2.7m. It was a spin-out from cannabis research co Greenlight Medicines and University College Dublin’s start-up accelerator, NovaUCD. No news on what stage this company’s at.