Finding promising ways to treat coronavirus (COVID-19) patients is the modern version of the search for the Holy Grail, but in one case - interferon - there is likely to be a satisfactory conclusion.
New York-based BetterLife Pharma Inc (CSE:BETR) (OTCQB:BETRD) has found that the coronavirus suppresses interferon production in the lungs. Interferon is a family of proteins produced by the body's immune system in response to an invading viral infection, “interfering” with the virus's ability to replicate. In the case of SARS-CoV-2, the specific virus strain that causes COVID-19, the virus blocks the “call to arms” function supported by interferon.
To counter this, BetterLife Pharma is focused on developing an interferon agent that can help fight the disease. It is developing AP-003, a proprietary interferon α2b (IFNa2b) inhalation formulation which will be given to patients through a nebulizer. In recent studies IFNa2b helped patients’ immune systems clear the coronavirus faster, it also reduced inflammatory proteins linked to severe complications.
Later this summer, BetterLife Pharma plans to kick off a 150 patient Phase 2 trial to test the nebulizer which turns the AP-003 drug into a fine mist which is inhaled and quickly delivered to the lungs. The interferon therapy will be used to lower hospitalizations, minimize tissue damage to the lung, heart, kidney, brain, and curb deaths.
Proactive talked with BetterLife Pharma CEO Ahmad Doroudian to find out more about the company’s program for COVID-19. A serial entrepreneur, Dr Doroudian is the founder of several companies including Altum Pharmaceuticals. Significantly, BetterLife is in the process of completing its merger with Altum Pharma which has developed AP-003.
BetterLife recently struck an agreement with Altum Pharma to work towards finalizing a “merger of equals.” Are you moving ahead with completing the merger and advancing Altum's pipeline, especially AP-003 and its potential as a COVID-19 treatment?
Yes, both groups have been working diligently towards completing the merger as soon as possible. We expect to complete the merger in the next four to six weeks. Currently, Altum’s team is working on advancing the AP-003 interferon alpha2b (IFNa2b) inhalation formulation for the treatment of Covid-19.
Can you talk about how your company is exploring the potential of using interferon as a treatment for COVID-19?
Interferon is a potent antiviral agent. Our company has been working on the development of a topical IFNa2b for treatment of Human Papiloma Virus (HPV) for the past three years. We have significant internal core competency to develop IFNa2b into an inhalation form. So, our group incorporated our knowledge of the IFNa2b into developing an IFNa2b inhalation formulation to conduct a clinical trial in Covid-19 patients.
When do you start clinical trials for AP-003?
We plan to start clinical trials sometime at the end of summer and beginning of Fall.
Can you talk about recent studies which find that AP-003 may potentially be effective against COVID-19 and other respiratory virus pandemics?
In the early part of the year when the pandemic started a study by Canadian and Chinese researchers conducted in Wuhan, China showed that Covid-19 patients treated with interferon inhalation showed significant improvement. The researchers published their findings in the 'Frontiers of Immunology' in May 15, 2020, in an article titled "Interferon-a2b Treatment for COVID-19." Led by Dr Eleanor Fish, of Toronto General Hospital, the researchers concluded that the use of IFNa2b on 77 patients with moderate cases of COVID-19 significantly accelerated clearance of the virus from the airways of patients and helped their overall recovery.
What are the other products in Altum’s pipeline that you are developing?
The other two products are AP-001, a topical formulation of IFNa2b for the treatment of HPV infection causing cervical cancer in women. AP-001 is to enter Phase 2 trials in early 2021.
Meanwhile, we have AP-002, a small molecule gallium based new chemical entity (NCE) that has direct anti-tumor cell killing activity with broad anti-cancer activity. AP-002 is going to enter Phase 1b trials later this year.
What are some major catalysts for BetterLife?
In the next three-to-six months, we expect the initiation and completion of the AP-003 Phase 2 trial, and approval under emergency use authorization.
BetterLife has acquired proprietary ingredient delivery systems, that can be utilized to develop potent commercial products in the personal care and nutraceutical space. How is that doing?
Our commercial team is expected to launch these products in the next four weeks under the brand BetterX through online platforms.
As the founder of Altum, Merus Labs International, and PanGeo what inspires you to be a serial entrepreneur?
I enjoy the challenges of creating new teams with diverse expertise to advance pharma and recently biotech projects. Working on developing a treatment for HPV infection and recently for Covid-19 is especially rewarding.
Contact the author Uttara Choudhury at [email protected]
Follow her on Twitter: @UttaraProactive