In a letter to shareholders issued as an update relating to COVID-19, Oramed Pharmaceuticals has highlighted the suitability of its platform technology for protein-based vaccines, including a vaccine against COVID-19, and the potential for partnerships for such a project.
The full Letter to Shareholders from company Chief Executive Officer Nadav Kidron follows:
LETTER TO SHAREHOLDERS
As the world faces an unprecedented challenge with much uncertainty, we at Oramed wanted to provide our shareholders and other constituents with an update on our business. Over the past weeks, we have closely followed the guidance of governments and leading public health institutes to ensure the safety of our employees. Additionally, we have conducted a business review to assess the potential impact of COVID-19. At this time, we continue to move ahead with all strategic initiatives and anticipate limited long-term impact from COVID-19. As our platform technology could be effective for protein-based vaccines, we are closely monitoring developments on the efforts to find a vaccine for COVID-19 and any potential partnerships on this front.
Oral Insulin (ORMD-0801)
We are moving ahead with the planning for our oral insulin (ORMD-0801) Phase III clinical studies and have accomplished several key milestones to this end. In February, Oramed conducted its initial End-of-Phase II (EoP2) meeting with the US FDA to discuss CMC of ORMD-0801 (Press Release dated March 19, 2020). The meeting followed the successful completion of Oramed’s Phase IIb study of ORMD-0801 for the treatment of Type 2 diabetes (Press Release dated November 12, 2019), which achieved its primary endpoint. During the meeting, the FDA provided feedback on key issues relating to Drug Product manufacturing. We are also looking forward to the second of the EoP2 meetings with FDA. This meeting will include a discussion of the results from the Phase II study and the design of the Phase III clinical studies proposed to support a license application for a Type 2 diabetes indication if the Phase III studies are successfully completed. During this meeting, we anticipate receiving the FDA’s guidance on the Phase 3 study design in order to take the next step of submitting the protocols and initiate planning for the Phase III programme at multiple clinical sites in the US and Europe. We have also requested a meeting with the EU EMA regarding our Phase III study design, as we intend to utilise clinical sites and file for marketing approval in Europe.
NASH Exploratory Clinical Study
Our NASH exploratory clinical study of oral insulin for the treatment of chronic liver disease assesses the efficacy of ORMD-0801 in reducing liver fat content, inflammation, and fibrosis. We intend to present data on the early patient cohort in the near future. We are expanding the trial to 30 patients and will shortly be adding additional sites in Israel, Europe and potentially the U.S.
Leptin Exploratory Clinical Study
We previously communicated our expectation of initiating and completing a Leptin proof-of-concept single dose study, evaluating the pharmacokinetic and pharmacodynamics of our oral Leptin drug candidate in 10 type 1 adult diabetic patients, during the first quarter of 2020. Due to the COVID-19 pandemic, enrolment has been delayed. The trial, however, is ready to resume once the health crisis is contained.
Chinese Clinical Trial
Due to COVID-19 our Chinese partner’s (HTIT) development progress was understandably slowed over the past few months. HTIT has confirmed that they are now fully back to work and in contact with the Chinese regulatory agency (NMPA) on moving forward to the next trials.
Following our recent financing of $21 million in March 2020 (Press Release dated February 27, 2020), Oramed is well funded with a cash position of roughly $50 million, which will allow us to progress smoothly into later-stage clinical trials. Our balance sheet remains flexible and strong with zero debt.
We will continue to assess the evolving COVID-19 situation and provide our constituents appropriate updates when possible. We are very optimistic in our business and believe that 2020 will be a very productive and event driven year for Oramed. We look forward to continuing the advancement of our clinical programs, particularly the initiation this year of a U.S. Phase III trial for ORMD-0801, which we believe positions Oramed to be the first to offer an oral insulin capsule for the treatment of diabetes.
Wishing you and yours good health,
Chief Executive Officer
Link to Press Release