A Better Response to Inflammation: Q&A with Dr. Ira Spector

Dr. Ira Spector
CEO
SFA Therapeutics

One of the issues with fighting inflammation is that anti-inflammatories can weaken or reduce the effectiveness of the immune system. Dr. Ira Spector, CEO of SFA Therapeutics, spoke with Pharmaceutical Executive about his company’s work at fighting inflammation without hurting the immune response.

Pharmaceutical Executive: How important is it to be able to stop inflammation without suppressing the immune response?
Dr. Ira Spector: Patients with autoimmune conditions have immune systems that attack healthy tissue, with inflammatory dysfunction being a key component of disease progression. Stopping pathological inflammation and restoring the immune system to a healthy state without suppressing its overall function is extremely important for effectively treating immunological disorders and maximizing drug safety. While initially effective in treating many disorders, the efficacy of immunosuppressive drugs may wane after only a few months. Currently available immunosuppressive drugs can make patients more vulnerable to infections and are often accompanied by an undesirable side effect profile such as headaches, nausea, and fatigue. Some patients opt out of continuing regular use of immunosuppressive drugs due to difficult dosing regimens, cumbersome routes of administration (i.e. injection or infusion), antibody formation and perceived intolerability of side effects. The goal of therapeutic development should ultimately be the modification of disease and restoration of a healthy state in the patient long-term by treating the underlying disease, rather than merely treating the symptoms of the disease.

PE: How does fine tuning human microbial metabolites into drugs achieve this response?
Spector: Many microbial metabolites play an important role in the regulation of immune homeostasis but lack the prerequisite specificity to target individual disease states. By starting with these endogenous compounds that are known to safely regulate the immune system in the human body and modifying their composition to amplify their effects on specific signaling pathways, we are able to target specific diseases. This approach allows us to restore homeostasis in patients with diseases where the immune system has become disregulated, with the goal of returning individuals to a healthy baseline.

PE: How does SFA’s immune-modulation platform work?
Spector: Our platform is designed to develop endogenous biosynthetic molecules based on microbial metabolites.

We start with an endogenously derived compound with a known role in maintaining immunological homeostasis. Through the use of disease-specific adjuvants, we then alter the molecule to target specific pathways known to be disregulated in the disease state we are interested in treating. We also apply medicinal chemistry principles to improve the molecule’s pharmacokinetic properties and modify it into a drug candidate with desirable dosing characteristics.

This approach gives us the advantage of starting with a molecule which has already been selected, through billions of years of evolution, for its effects in maintaining human health.We then have the benefit of applying modern science to develop these endogenous chemicals into biosynthetic drug candidates which can be administered orally and used to treat specific diseases.

PE: What is the status of SFA’s pipeline?
Spector: We are currently advancing our lead asset, SFA-002, through a phase 1b clinical trial for the treatment of mild-to-moderate chronic plaque psoriasis. Patient enrollment in the clinical trial has already been completed and we anticipate topline data in the coming months.We previously saw some very promising results in the first cohort of patients treated and are looking forward to initiating a phase 2/3 clinical trial. We expect SFA-002 to be effective in a class of autoimmune diseases that include RA, Lupus, MS and Crohn’s and colitis.We are exploring additional assets across a range of other chronic inflammatory conditions, including an adjunctive treatment in combination with standard of care chemotherapeutics for pancreatic cancer, a treatment for liver cancer (HCC), a drug for chronic liver diseases including fibrosis and MASH/NASH, and other autoimmune conditions.