Biotechnology company Lusaris Therapeutics – which has a lead programme focusing on DMT for treatment-resistant depression – has launched with its Series A financing of US$60 million (~£52.01m).
Lusaris Therapeutics’ lead programme, LSR-1019, is a sublingual formulation of 5-MeO-DMT, a fast-acting and rapidly clearing serotonergic psychedelic. The formulation is being developed for patients with treatment-resistant depression (TRD) and other severe neuropsychiatric disorders.
RA Capital Management incubated Lusaris and led the Series A round with participation from leading healthcare investors including Venrock Healthcare Capital Partners, Deep Track Capital, Boxer Capital, and an additional undisclosed investor.
Interim Chief Executive Officer of Lusaris and Partner and Managing Director at RA Capital, Andrew Levin, M.D., Ph.D., commented: “Major depressive disorder is a severe, debilitating, and inadequately treated disease resulting in millions of patients progressing to TRD.
“Psychoplastogens have emerged as a promising treatment approach supported by compelling scientific evidence in patients with TRD and other severe neuropsychiatric conditions.
“We believe LSR-1019, our proprietary sublingual formulation of 5-MeO-DMT, has the potential to provide an important therapeutic advance for patients with severe depression who lack effective treatment options.”
The need for innovation in TRD care
TRD occurs when patients with major depressive disorder do not respond adequately to two lines of therapy. There is a tremendous need for new therapies for patients not adequately controlled with currently available treatments.
Serotonergic neuroplastogens have been shown to induce favourable structural and functional neural plasticity, resulting in rapid and dramatic improvement in patients with TRD.
Existing clinical data suggest that 5-MeO-DMT has the potential to offer best-in-class efficacy in people with TRD.
Orally administered 5-MeO-DMT is pharmacologically inactive due to rapid metabolism by enzymes in the gut and liver. LSR-1019 is a proprietary sublingual tablet formulation of 5-MeO-DMT that dissolves under the tongue within seconds and is absorbed without the need for water.
This 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. Lusaris plans to develop LSR-1019 for the treatment of TRD and additional severe neuropsychiatric disorders. Phase 1 clinical studies of LSR-1019 are expected to initiate imminently with topline data available mid-year 2023.
Exclusive delivery technology
The company has also announced that it has entered into a strategic collaboration with Catalent under which Lusaris has been granted an exclusive worldwide license to Catalent’s Zydis® fast-dissolving tablet technology for the 5-MeO-DMT programme.
The Zydis ODT (orally disintegrating tablet) technology has been used in more than 35 commercial products in over 60 countries.
Chief Operating Officer at Lusaris, Neil Buckley, commented: “We aim to develop best-in-class neurotherapeutics that have the potential to reach more patients in need by decreasing the treatment burden on both patients and physicians.
“With encouraging preclinical data, a proven delivery technology, and an expected rapid and short psychotropic experience, LSR-1019 has the potential to be a transformative treatment for patients suffering from TRD and other serious mood disorders.”
In addition to LSR-1019, Lusaris is building a portfolio of novel serotonergic neuroplastogens for a wide range of neuropsychiatric and neurological conditions, including migraine and cluster headache.
