SOM Biotech presents positive Phase 2a data with SOM3355 at
SOM Biotech present positive Phase 2a Data with SOM3355 at the 34and ECNP Congress 2021
~Data show SOM3355 reduces chorea in patients with Huntingdon’s disease and has a good safety profile~
~SOM3355 discovered via SOM Biotech proprietary computing technology based on artificial intelligence SOMAI PRO~
Barcelona, Spain, 4 October 2021 – SOM Biotech, a clinical-stage biopharmaceutical company with proprietary AI-based drug discovery technology focused on orphan diseases of the central nervous system, today announces that it will present positive Phase 2a data with SOM3355, an oral vesicular monoamine transporter 2 (VMAT2) for the symptomatic treatment of chorea movements associated with Huntington’s disease (HD), at 34and ECNP Congress from October 2 to 5, 2021 in Lisbon, Portugal.
HD is an inherited disease in which progressive degeneration of the brain centers involved in movement can lead to chorea, an involuntary, jerky movement that randomly affects somatic muscles and circulates from one part of the body to another. Xenazine (tetrabenazine), a VMAT2 inhibitor, is currently approved to treat chorea in HD despite serious side effects, including sedation, drowsiness, parkinsonism, and risk of depression and suicidality.
Using the company’s proprietary computer technology based on artificial intelligence (SOMAI PRO), SOM Biotech has identified SOM3355 or Bevantolol hydrochloride1 as an alternative VMAT2 inhibitor that could be repurposed to treat chorea in HD and potentially eliminate severe xenazine side effects. The chemical structure of the molecule differs significantly from xenazine and SOM3355 is thought to reduce chorea by inhibiting VMAT2 through a different mechanism.
The Phase 2a study was a double-blind, randomized, placebo-controlled study designed to evaluate the efficacy and safety of SOM3355 in HD patients with chorea. A total of 32 patients were enrolled in the study and randomly assigned to two arms of four six-week sequential periods during which they received placebo and SOM3355 100 and 200 mg twice daily in a crossover design. .
The study met the primary endpoint, with 57.1% of patients improving their total maximal chorea (TMC) score by at least two points during any period after treatment with SOM3355 compared to placebo. Even greater improvements in TMC score of three, four, five and six points over placebo were observed with SOM3355 in 28.6%, 25.0%, 17.9% and 10.7% of patients, respectively . Overall, SOM3355 was well tolerated with only mild to moderate side effects, the most common being due to the drug’s already known side effects, including headache, fatigue, nausea, and vomiting.
dr. Raúl Insa, CEO of SOM Biotech commented: “Huntington’s disease causes progressive degeneration of nerve cells in the brain and as such has a significant negative effect on patients’ quality of life, both physically and mentally. There is a huge unmet medical need for new treatment options to treat HD symptoms, including chorea, and we are very encouraged by the results we have seen so far. We will continue to advance SOM3355 into the clinic and plan to begin a Phase 2b trial later this year to bring this promising product candidate to patients as soon as possible. »
Session title: Dedicated poster session to interact with presenters
Summary Jtitle : Proof-of-concept study testing SOM3355 for the treatment of chorea symptoms in Huntington’s disease
Date and hour : Monday, October 4, 12:00 p.m.-1:00 p.m. CET
Presentation Number: P.0426
The full summary can be viewed here.
About SOM Biotech: SOM Biotech (www.sombiotech.com) – established in 2009 – is a biopharmaceutical company based in Barcelona, Spain. SOM has an extensive product portfolio that includes drugs for orphan diseases including TTR amyloidosis, Huntington’s disease, tardive dyskinesia, phenylketonuria, Niemann-Pick C, glioblastoma and Parkinson’s disease. The Company is committed to the accelerated discovery of therapies through proprietary computational technology based on artificial intelligence (SOMAI PRO) and develops strategic partnerships with major research centers and pharmaceutical laboratories.
On SMOAI PRO: SMOAI PRO is the company’s proprietary AI-based drug discovery technology. The Company successfully uses technology to identify effective drugs for the treatment of a specific disease, to discover new mechanisms of action and new applications for a drug, and to predict the toxicity of compounds, as well as molecular scaffolds for new chemical entities. . The key strength of the technology is its high success rate, with two of the Company’s programs already achieving positive Phase 2a results. Moreover, while other AI-based approaches use methods based on data mining, structural similarity or target structure, SOMAI PRO uses molecular fields, allowing for an increased success rate, with results achieved in the shortest possible time and significantly reducing the costs associated with drug discovery.
About SOM3355: SOM3355 is potentially the only safe VMAT2(-) not linked to serious adverse events such as depression, suicide, parkinsonism or neuroleptic syndrome. It has a potential peak maximum sales of 1.1 billion euros. The Company intends to launch a phase 2b later this year.
For more information on SOM Biotech, please contact:
Consilium Strategic Communications
Amber Fennell, Lindsey Neville, Lucy Featherstone
1 Bevantolol hydrochloride is currently marketed as Calvan® in Japan, South Korea and China for the treatment of hypertension.