Biotechnology company Saniona develops the lead candidate Thesomet for the treatment of patients with Prader-Willi syndrome (PWS) and hypothalamic obesity (HO), two serious, rare diseases in which unmanageable weight gain, disturbances in metabolic function and uncontrollable hunger dominate the patients' everyday lives.
The pipeline also includes drug candidates as well as ion channel modulators. SAN711 and SAN903. SAN711 is currently undergoing Phase I clinical trials, with potential applications in the treatment of rare neuropathic diseases. SAN903 is being developed for rare inflammatory, fibrotic and hematological diseases, and is in preclinical development. A Phase I study with SAN903 is expected to commence in H2 2022.
Regulatory progress with Tesomet
During the second quarter, Saniona announced a partnership with the foundation Foundation for Prader-Willi Research to increase awareness of clinical trials and the company also received a notice regarding manufacturing from the US Food and Drug Administration FDA due to the transition from tablet to capsule. These steps were taken in advance of the Phase II clinical trials of Tesomet for HO and PWS that are expected to begin later this year.
Saniona also announced that it has received orphan drug designation from the FDA for Tesomet for the treatment of HO, making Tesomet the first and only investigational drug for the disease to receive orphan drug designation. The company had previously received orphan drug designation for Tesomet in PWS in the first quarter. Topline results are expected to be available in the first half of 2023 for the PWS study and in the second half of 2023 for the HO study.
»During the first half of 2021 and beyond, Saniona has made significant progress in both clinical and regulatory terms, with Tesomet receiving FDA orphan drug designation in both hypothalamic obesity and Prader-Willi syndrome. The designations give us a strong position as we prepare to start Phase 2b studies with Tesomet in both HO and PWS before the end of the year« – Rami Levin, President and CEO of Saniona
SAN711 also advances
In the second quarter of 2021, Saniona achieved success with the initiation of a Phase 1 clinical trial with SAN711, the company's first wholly owned asset from its drug discovery platform, moving from preclinical to clinical. Data from the trial are expected in the first half of 2022.
Saniona was also able to present preclinical data for SAN711 in a model of neuropathic facial pain at a congress for the European Academy of Neurology (EAN).
Saniona has also taken important steps with SAN903 during the period when it was able to present preclinical results in a model of idiopathic pulmonary fibrosis in American Society of Pharmacology and Experimental Therapeutics annual meeting (ASPET). Phase I studies with SAN903 are expected to begin in the second half of 2022.
New loan agreement
In July, Saniona secured a non-dilutive term loan of SEK 87 million (USD 10 million) with Formue Nord Focus A/S to finance new activities that will accelerate the implementation of the clinical development programs.
Collaborations
In June, an update came from Saniona's partner Medix that a Mexican regulatory committee has requested additional information from the ongoing review of the drug candidate tesofensine which is being developed as a new treatment for obesity. This means that the final decision on market approval may be delayed until 2022.
Additions to the board may possibly take place in September
The news flow from Saniona so far this year has been dominated by important regulatory and clinical successes in the US. That said, we can also note that the company has called an extraordinary general meeting on September 16 to elect a new board member, Robert E. Hoffman, an experienced financial expert with extensive experience of board work in listed companies. This is en naturlig development av the board of directors, and the reflects the Sanionas Operation has developed in just over a year.
The fact to he has shown interest - for to support Sanionas way Forward, do not least but when the applies en possibly American listing, is one clearly tecken of to the company has done bra from sig but when the applies to establish headquarters i Boston Massachusetts area, at the same time as the research organization has been retained i Denmark.
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