Ocular Therapeutix’s dry eye disease insert fails in phase 2 trial
Ocular Therapeutix declared that its OTX-CSI (cyclosporine intracanalicular insert) for dry eye disease (DED) has flunked to reach the primary endpoint in the phase 2 clinical trial.
The company has conducted the US-based, randomised, double-masked, multi-centre and vehicle-controlled clinical trial to evaluate the safety, tolerability, durability, and efficacy of two different formulations of OTX-CSI.
It was designed to be carried out by assessing signs and symptoms of dry eye disease in 140 subjects treated in both eyes over nearly 16 weeks. Ocular Therapeutix had administered OTX-CSI in 147 subjects with DED at 15 sites in the US as part of the trial.
The study evaluated four groups that comprise OTX-CSI for a shorter duration (2-3 months formulation-F1, 42 patients) and OTX-CSI for a more extended period (3-4 months formulation-F2a, 40 patients). Other groups comprise vehicle insert for a longer duration (3-4 months formulation-F2b, 43 patients) and vehicle insert for a concise course (one week formulation-F3, 22 patients).
As per the company, the trial has flunked to show separation between the OTX-CSI treated subjects and the vehicle-treated subjects for the primary endpoint of increased tear production at 12 weeks as measured by the Schirmer’s Test.
Click Therapeutics raises USD 52 Million funding for prescription digital therapeutic pipeline
Click Therapeutics has secured USD 52 Million in a Series B financing round to enhance its internal prescription digital therapeutic pipeline and platform capabilities.
Co-led by new investors H.I.G. BioHealth Partners and Accelmed Partners II, the financing round observed participation from Health Catalyst Capital, Revelation Partners, and a top biotechnology hedge fund. The round also comprised existing investors Sanofi Ventures, K2 HealthVentures, Hikma Ventures, and Ridgetop Health.
Click Therapeutics will utilise the proceeds from the existing financing round to enhance the development and commercialisation of its internal prescription digital therapeutic pipeline and expedite its platform capabilities.
Click’s pipeline includes advanced digital therapeutics that can be utilised in several therapeutic areas ranging from psychiatry and chronic pain to cardiometabolic and autoimmune disorders.
The company has signed a partnership agreement with Otsuka to develop and commercialise a prescription digital therapeutic to treat the major depressive disorder (MDD).
Click has also entered into a collaboration agreement with Boehringer Ingelheim to develop and market prescription-based digital therapeutics for schizophrenia treatment.
Roche introduces new AVENIO Tumour Tissue CGP Kit
Roche has extended its thorough genomic profiling (CGP) portfolio to launch a new AVENIO Tumour Tissue CGP Kit.
The jointly-developed product that complements the current CGP portfolio proffered by Roche and its subsidiary Foundation Medicine will allow laboratories to extend their in-house oncology research.
The future version of the kit is also anticipated to result in more resources for clinicians to use in the diagnosis and cancer treatment.
The research utilises only next-generation sequencing test is designed to deliver an end-to-end workflow from DNA extraction and library preparation for generation of variant results by the FoundationOne Analysis Platform via AVENIO Connect.
By utilising a gene panel based on the FoundationOne platform, the kit will help match the FoundationOne CDx panel content to evaluate 324 cancer-related genes across four main classes of genomic alterations and genomic signatures known to cause and drive cancer.
Each kit is designed to run 24 samples, and the entire workflow from DNA isolation to variant results will be completed in five days. In contrast to smaller panels such as hotspot or single-gene tests, the CGP test offers thorough information in a single test and information on complex genomic signatures such as tumour mutational burden (TMB), microsatellite instability (MSI) and loss of heterozygosity (LOH).
Blue Wolf Capital to acquire CIVCO Radiotherapy
New York-based private equity company Blue Wolf Capital Partners has agreed to buy CIVCO Radiotherapy from Roper Technologies for an unrevealed sum. CIVCO Radiotherapy, established in 1982, is involved in the designing and manufacturing of radiotherapy patient positioning and immobilisation devices. The company’s devices proffer safe cancer treatment to patients.
CIVCO supplies its products to academic and community hospitals, cancer centres and original equipment manufacturer (OEM) manufacturers.
CIVCO carries out operations in more than 90 countries globally with around 115 employees. The company has its headquarters and production facilities in Iowa.
CIVCO Radiotherapy current president Nat Geissel said they are happy to have found a trusted partner in Blue Wolf with the skills, expertise and capital to bolster their primary growth goals and mission of improving outcomes for patients and healthcare providers globally. Upon completion of the deal, Geissel will be appointed as the CEO of the company.
Blue Wolf Capital principal Shashank Patel said that the company has a rich history of enhancing cancer patients’ experience and clinical outcomes globally. They contemplate CIVCO Radiotherapy as well-positioned to further benefit clinicians offer more targeted and accurate treatment to patients as innovations in the radiotherapy space continue. The deal is anticipated to be completed by the end of this year.