Psyched: Next-Gen Compounds For Depression, Congress, Rescheduling, Benzinga Psychedelics Conference & More

Major Depressive Disorder: Small Pharma’s Phase 2 DMT Trial, BetterLife’s Preclinical LSD Trial

Short-acting psychedelics biotech company Small Pharma Inc. DMTTF shared positive outcomes from its Phase 2a study of SPL026, the first placebo-controlled trial of the DMT-based short-duration psychedelic compound for the treatment of Major Depressive Disorder (MDD). 

The trial assessed both the efficacy and safety of a 21.5mg IV dose of SPL026 paired with supportive therapy in 34 patients with moderate to severe MDD. It was split into two phases, the first a two-week blinded, randomized, placebo-controlled trial followed by a 12-week open-label stage in which all participants received one dose of the psychedelic compound.

Analyses of secondary and exploratory endpoints like effects on self-reported depression, anxiety and well-being -areas often negatively impacted by depression- demonstrated that patients receiving at least one dose of the psychedelic experienced clinically relevant improvements in function and mood. 

Learn more on the Phase 2 trial HERE.

Meanwhile, comparably less advanced but still pretty eagerly, BetterLife Pharma Inc. BETRF’s lead drug candidate LSD analog BETR-001 has also shown positive results in a preclinical study assessing it as a potential treatment for mood disorders. 

In preclinical and IND-enabling studies, BETR-001 is a non-hallucinogenic and non-controlled LSD derivative with the potential for self-administration, which BetterLife is aiming to patent for the treatment of Major Depressive Disorder (MDD,) anxiety disorder and neuropathic pain, among other conditions.

These outcomes of 2-bromo-LSD or BETR-001’s therapy, published in the peer-reviewed journal Cell Report, further support previous positive data through an extensive pharmacological characterization of the novel compound compared to LSD.

Distinct CNS receptors pharmacological differences between BETR-001 and LSD included: 

• 5-HT2A receptor partial agonism and no psychedelic-like effects in vivo for BETR-001 in contrast to LSD

• 5-HT2B agonism was caused by LSD but not by BETR-001, leading to a potentially safer cardiovascular profile. 

• BETR-001 induces neuroplasticity in vitro and in vivo while promoting active coping behavior in mouse models of depression and anxiety.

Learn more on this non-hallucinogenic version of LSD and its upcoming development steps HERE. 

Bipartisan Lawmakers Introduce Rescheduling Bill To Enable Psychedelics Research

Senators Cory Booker (D-NJ), Rand Paul (R-KY) Reps Madeleine Dean (D-PA) and Nancy Mace (R-SC) filed a revised bill requesting an update on the federal scheduling of “breakthrough therapies” -an FDA designation for certain treatments involving psilocybin and MDMA- towards advancing R&D and improving access for those in need, reported Marijuana Moment.

While the bill’s original version included sections calling for a simpler registration process for researching Schedule I drugs, the new “Breakthrough Therapies Act” would amend the Controlled Substances Act (CSA) to move Schedule I drugs, either breakthrough therapies or those qualifying for a waiver under the Food, Drug & Cosmetic Act (FDCA), to Schedule II, thus facilitating their study as well as promoting drug development.

Though drugs moved to Schedule II under the new measure could be placed back in Schedule I if they no longer have accepted medical uses and if the head of the HHS  recommends it to the attorney general.

Learn more on the bipartisan and bicameral proposal HERE.

Benzinga’s Psychedelics Event Is Just Around The Corner

The psychedelics industry is an absolute reality and we want to offer our readers the chance to get acquainted with some of the sector’s most knowledgeable people. 

That’s why we’ve launched a second edition of the Benzinga Psychedelics Capital Conference. Set for April 13 and following our established Cannabis Capital Conference, the PCC will also take place at the Fontainebleau Miami Beach Hotel, in Florida.

This past week, we’ve been announcing some of the great minds you’ll get to listen to and interact with if you’re planning to attend, including absolute psychedelics researcher Dr. Matthew Johnson; knife-precision business advisors Kevin Harrington, Courtney Barnes, Bryan Passman and David Traylor; directors of bursting companies like Joseph Tucker ENVB, Najla Guthrie KONEF and Kaia Roman BWVI; and, of course, insightful, long-time entrepreneurs Andrew Chomer VC Integrated), Simeon Schnapper (JLS Fund), and Dan Ahrens (AdvisorShares.)   

Do rush to get your tickets, as prices will go up soon!

The Milestone Round

Each week, Benzinga learns about new clinical trials, the creation of psychedelic-based compounds and novel potential treatments for those suffering from mental and physical health conditions.

Business update:

• MindMed MNMD has reported its yearly financials, numbers adding up and expecting cash runway for operations well into H1 2025.

• atai Life Sciences ATAI has shared updates on its clinical pipeline as well as announced a considerable 30% workforce layoff.

• Wellbeing Digital Sciences’ well-known subsidiary KGK Science is advancing the road towards a Health Canada-approved license to produce several controlled substances including LSD, DMT, psilocybin, MDMA and ketamine for research purposes.

• Adastra Labs XTXXF has provided clarification regarding its recently granted Canadian dealer’s license to produce controlled substances including cocaine.

• Mindset Pharma MSSTF has signed an exclusive sales partnership with PharmAla Holdings and delivered a first batch of clinical-grade psilocybin to Australia. 

Orbiting the wellness space, we heard of Dr. Deepak Chopra’s latest partnership with giant business The Healing Company.

Finally, the MAPS psychedelics annual gathering has announced its featured speakers and agenda for its 2023 edition.

Check out the list of the ten companies that have had the highest-priced stocks in the sector in the past year. 

See also: Last Week's Edition Of 'Psyched'

Psychedelics ETFs Weekly Performance

This is how the sector’s major ETFs performed in the week spanning March 6-10.

• AdvisorShares Psychedelics PSIL opened Monday 6 at $2.00, lower than past Monday, Feb. 27 at $2.14. The week saw a downward trend with a closing price of $1.81 on Friday, March 10, also considerably lower than the already low closing at $2.01 on Friday, March 3.
  For this ETF, the yearly price range was once set between $6.26 and $1.82, and after gradual changes in the past month when the range was set between $5 and $1.79, later redefined to highest $4.56 and lowest $1.79, and now again has been changed to be $4.35-$1.78.

• The Elemental Advisors PSYK ETF PSYK began Monday, March 6 at a good $17.65 after former opening at $17.15 on Monday, Feb. 27. That number fell during the week all the way to closing price $16.31 on Friday, March 10, considerably lower than former closing at $17.76.
  For this ETF, the yearly price range was set between $23.32 and $16.70, and now the lowest price has been adjusted to $16.28.

The second edition of the Benzinga Psychedelics Capital Conference is inching closer each day!

Taking place in the Fontainebleau Miami Beach Hotel in Florida on April 13, 2023, the event’s THE place to get DEALS DONE, raise money, jumpstart M&A and meet investors and key partners.

Secure your tickets now before prices go up.