Small Pharma Implements Costs Cut: New R&D Strategy And Management Team Change

Together with reporting its annual financial results and pipeline update, short-acting psychedelics developer Small Pharma Inc. DMTTF stated its intentions to reduce its “historical” cash burn.

The company has also updated its research and development (R&D) strategy.

Small Pharma now aims to expedite novel deuterated DMT compound SPL028’s clinical program, which is currently undergoing the dosing stage in a Phase 1 study. 

Preliminary Findings: The first two trial cohorts show that intravenous (IV) SPL028 produces a psychedelic experience of less than one hour long and is well-tolerated.

The compound’s “strong commercial proposition” takes base in an anticipated short in-clinic treatment (less than total 2 hours and a half including dosing with therapy) delivering “a rapid and durable antidepressant response,” as supported by the related SPL026 Phase 2a data; as well as a “robust” multi-layered IP protection.

Specifically, development of the SPL028 program — including dosage — is informed by data from Small Pharma’s clinical trials on SPL026, the company’s “native” DMT compound showing sound and long-lasting positive outcomes for the treatment of Major Depressive Disorder (MDD).

Expedited Path: Lead drug candidate SPL026, also short-duration and DMT-based, has been granted an Innovation Passport designation by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA).

Small Pharma expects that the combined data from the SPL026 and SPL028 programs enables an expedited path to initiating a multi-jurisdiction, multi-site Phase 2 study in 2024. Accordingly, the SPL028 Phase 1 program’s protocol includes the option of initiating a Phase 1b patient study of injectable SPL028 for participants with depression. 

What's Next?: Topline data from the ongoing Phase 1 study is expected in the fourth quarter of 2023, and will help determine the optimal development route for SPL028 including the targeted depression patient population. 

C-Suite Shakeup

Peter Rands — Small Pharma's co-founder, chief innovation and IP officer, and former CEO — has left his positions, effective July 1.

The company’s current head of IP, patent attorney Emma Hodge, will lead development and strategy in the department following Rands’ departure as chief innovation and IP officer. 

The company is also making a 30% headcount reduction, including COO Alastair Riddell, who will be succeeded by the current chief manufacturing and development officer and previous COO Marie Layzell.

Rands said he started Small Pharma in 2015 “with a vision to create innovative pharmaceutical products based on known compounds that could be transformative for people suffering from mental health disorders.”

The company’s board chair, Lyne Fortin, recognized and thanked Rands’ “original vision” and “tenacity in pursuing it.” Small Pharma will continue developing novel mental health treatments “for millions of patients worldwide” under the leadership of CEO George Tziras, she added.

Photo: Benzinga edit with photo by RF._.studio by Pexels and Jynto on Wikimedia Commons.