November 17, 2021

Saniona (OMX: SANION), a medical stage biopharmaceutical firm centered on uncommon illnesses, immediately introduced the initiation of a Phase 2b medical trial of Tesomet in sufferers with hypothalamic weight problems (HO). Tesomet is an investigational fixed-dose mixture remedy of tesofensine, a triple monoamine reuptake inhibitor, and metoprolol, a beta-1 selective blocker. Data from the trial are anticipated within the second half of 2023.

“The initiation of this Phase 2b medical trial represents the end result of the numerous work and mixed experience of our medical, regulatory, technical operations and high quality groups,” stated Rudolf Baumgartner, M.D., Chief Medical Officer and Head of Clinical Development at Saniona. “We are additionally getting ready to provoke a Phase 2b medical trial of Tesomet in Prader-Willi syndrome earlier than the tip of the 12 months, which, mixed with our ongoing Phase 1 trial for SAN711, means our group will finish the 12 months with three rigorous medical packages underway.”

The Phase 2b medical trial features a randomized, double-blind, placebo-controlled 36-week therapy interval adopted by a 36-week open-label extension interval. The trial will search to enroll roughly 110 members 16 years of age and older with hypothalamic weight problems – a uncommon illness brought on by injury to the hypothalamus. During the 36-week double-blind interval, members will likely be randomized to obtain each day dosing with Tesomet at one among three dose ranges or placebo. During the 36-week open-label extension interval, all members, together with those that initially obtained placebo, will obtain the best tolerated dose of Tesomet as established through the double-blind interval. The major endpoint of the research is the proportion change in physique weight from baseline to week 36. Secondary endpoints embrace the proportion of members who meet pre-specified thresholds for physique weight reduction at week 36, in addition to change from baseline to week 36 in physique weight, waist circumference, and physique mass index.

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The medical trial is being performed at a number of websites world wide together with within the United States, New Zealand, Australia, and in a number of international locations in Europe together with the United Kingdom, Sweden, Italy, Spain and others. More info is obtainable at www.hypothalamicstudy.com or www.clinicaltrials.gov.

Amy Wood, Executive Director of the Raymond A. Wood Foundation and mother or father of a kid residing with hypothalamic weight problems, commented, “Hypothalamic weight problems is a devastating situation that causes extreme weight achieve even when meals is restricted – and there are presently no FDA-approved remedies. Earlier this 12 months, the FDA awarded Tesomet the first-ever orphan drug designation for HO, which was a big milestone for the HO group, and we’re so excited to now see one other milestone achieved with the initiation of the trial.”

“Management of hypothalamic weight problems is extraordinarily tough as a result of customary approaches to treating weight problems resembling way of life counseling, drugs for basic weight problems, and even surgical procedure are largely ineffective on this inhabitants,” stated Ashley Shoemaker, Attending Physician, Assistant Professor of Pediatrics, Pediatric Endocrinology, Vanderbilt University Medical Center. “We desperately want therapy choices for HO, and I’m inspired to see Saniona provoke this medical trial.”

Saniona beforehand evaluated Tesomet in a randomized, double-blind, placebo-controlled preliminary Phase 2 trial in adults with HO. In the research, Tesomet was usually nicely tolerated and led to a statistically important discount in physique weight, in addition to enhancements in waist circumference and glycemic management. Tesomet obtained the first-ever orphan drug designation in HO from the FDA, and the FDA has confirmed that Tesomet could also be superior through the 505(b)(2) regulatory pathway. Saniona is partnering with the Raymond A. Wood Foundation to tell the medical trial design and medical growth processes, and to lift consciousness inside the HO group.

Saniona can be evaluating Tesomet for the therapy of Prader-Willi syndrome (PWS) and plans to start a Phase 2b trial in on this indication earlier than the tip of this 12 months. The FDA granted Tesomet orphan drug designation in PWS in March 2021.

For extra info, please contact
Trista Morrison, Chief Communications Officer, Saniona. Office: + 1 (781) 810-9227. Email: trista.morrison@saniona.com

The info was submitted for publication, by the company of the contact individual set out above, at 8:00 CET on 17 November 2021.

About Saniona
Saniona is a clinical-stage biopharmaceutical firm centered on discovering, growing and commercializing progressive therapies for sufferers affected by uncommon illnesses for which there are an absence of obtainable therapy choices. The firm’s lead product candidate, Tesomet, is in mid-stage medical trials for hypothalamic weight problems and Prader-Willi syndrome, critical uncommon problems characterised by extreme weight achieve, disturbances of metabolic features and uncontrollable starvation. Saniona has developed a proprietary ion channel drug discovery engine anchored by IONBASE™, a database of greater than 130,000 compounds, of which greater than 20,000 are Saniona’s proprietary ion channel modulators. Through its ion channel experience, Saniona is advancing two wholly-owned ion channel modulators, SAN711 and SAN903. SAN711 is in a Phase 1 medical trial and could also be relevant within the therapy of uncommon neuropathic problems, and SAN903 is in preclinical growth for uncommon inflammatory, fibrotic and hematological problems. Led by an skilled scientific and operational group, Saniona has a longtime analysis group within the Copenhagen space, Denmark, and a company workplace within the Boston, Massachusetts space, U.S. The firm’s shares are listed on Nasdaq Stockholm Small Cap (OMX: SANION). Read extra at http://www.saniona.com.

About Tesomet
Tesomet is an investigational fixed-dose mixture remedy of tesofensine (a triple monoamine reuptake inhibitor) and
metoprolol (a beta-1 selective blocker). Saniona is advancing Tesomet for hypothalamic weight problems and Prader-Willi
syndrome, two critical uncommon problems characterised by extreme weight achieve, disturbances of metabolic features and uncontrollable starvation. The packages are presently in medical growth. Saniona holds worldwide rights to Tesomet and is actively evaluating alternatives to advance this therapy globally.

About Hypothalamic Obesity (HO)
Hypothalamic weight problems (HO) is a uncommon dysfunction brought on by harm to a area of the mind generally known as the hypothalamus. This harm is mostly sustained throughout surgical procedure to take away a noncancerous tumor known as a craniopharyngioma (CP). HO is characterised by speedy, extreme, and intractable weight achieve that persists regardless of restricted meals consumption. Patients might have hyperphagia, an uncontrollable starvation, and will show irregular meals in search of habits resembling stealing meals. Additional signs might embrace reminiscence impairment, consideration deficit, extreme daytime sleepiness and lethargy, points with impulse management, and despair. HO sufferers are additionally at elevated danger of growing obesity-related comorbid situations resembling Type 2 diabetes, non-alcoholic fatty liver illness, hypertension, stroke, and congestive coronary heart failure. Ultimately, CP survivors with in depth hypothalamic harm report a 20-year mortality fee at the least thrice larger than CP survivors with out in depth hypothalamic harm. There are not any drugs permitted particularly for HO, and there’s no remedy for this illness. Many HO sufferers are handled with approaches used for basic weight problems resembling surgical procedure, treatment and way of life counseling, however these are principally ineffective. The variety of sufferers with of HO is estimated to be between 10,000 and 25,000 within the U.S. and between 16,000 and 40,000 in Europe.



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By Seth A. Dunbar

Seth Dunbar leads clinical research study operations and quality & compliance. He is experienced working with teams to help drug sponsors better leverage eSource data. With 10+ years of experience Seth brings expertise developing eClinical services that integrate data and technology to help companies optimise study execution.

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