Pharma Companies Foray into the ABSSSI Market to Develop Novel Antibiotics and Tackle Antibiotic Resistance

The introduction of antibiotics subsequently transformed the healthcare industry bringing on the table several life-saving drugs. Long 60 years back, when the first antibiotic, Penicillin, came into existence, a new era of medicine with the potential to cope up with bacterial infections began. 

However, the magic of magic bullets, that kill only the pathogen sparing the host, seems to have diluted now as today there is an increasing number of antibacterial resistance incidents with the existing drugs.  The magic bullets that saved plenty of lives at one point of time are less effective right now. Going by the numbers, more than 2.5 million Americans experience antibiotic resistance each year, and more than 35,000 people die as a result. 

With antibiotics losing their charm in the race, humankind is put at risk of developing life-threatening conditions posing a great challenge to modern medicine. Although, one might argue that the introduction of new antibiotics can prove to be an exit from the situation, however, there are several challenges and barriers associated with it including lack of large scale epidemiological cohorts and studies, regulatory challenges, scientific limitations, financial constraints, clinical and statistical inferiority of drugs, and so on.  According to a report by the WHO, a serious lack of efforts in developing new antibiotics for bacterial infections has put the global healthcare system on the verge of threat. Antibiotics not only help in curing bacteria infections, but also play an important role in the treatment of other conditions, and medical procedures such as surgeries. And, this is what poses a huge market barrier in the growth of ABSSSI therapy market size. 

Acute Bacterial Skin and Skin-Structure Infection (ABSSSI) is defined as a bacterial infection, complicated complicated skin and soft tissue infection with a lesion size area of ≥ 75 cm2 (lesion size measured by the area of redness, edema or induration). Increasing significantly in incidence, today ABSSSI has become a serious dilemma imposing a huge financial burden on the healthcare industry. In the United States alone, over 15 million cases of bacterial skin and skin structure infections occur. 

Generally, the treatment of ABSSSI comprises antimicrobial therapy, surgical drainage and antibiotic therapy. To address skin infections, adjunctive therapies, early and appropriate empiric antibiotic therapy, wound culture with susceptibility testing and surgical drainage and debridement are available. Long-acting antibiotics continue to be the major treatment gold-standard. However, there is an alarmingly increase in the number of antibiotic resistance. 

According to the Director-General of WHO, Dr Tedros Adhanom Ghebreyesus, the issue of antimicrobial resistance is immediate and needs to be dealt with utmost precedence, however, a  collective effort from government and private institutions in stepping up the funding and developing innovative drugs would help make the difference. 

According to DelveInsight, numerous pharmaceutical companies are working in the ABSSSI market to make an impact and come up with solutions. Pharmaceutical companies including Innovation Pharmaceuticals, Motif Bio, Basilea Pharmaceutica, Debiopharm, Destiny Pharma, KBP Biosciences, MicuRx Pharmaceuticals, and several others are working in the synergy to develop innovative medicines to speed up the growth of the ABSSSI market size. 

ABSSSI Pipeline Review 

Recently, Melinta Therapeutics announced the USFDA approval for its Kimyrsa (oritavancin)  for the treatment of adult patients with acute bacterial skin and skin structure infections caused by susceptible isolates of designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA). Melinta is long working in the ABSSSI market to develop innovative therapies. 

Basilea Pharmaceutica has announced the completion of phase III clinical investigation of its drug Ceftobiprole/ Zevtera (also known Ceftobiprole medocaril) for ABSSSI. The company had received funding from the BARDA to help it continue and complete the trials successfully. Ceftobiprole is a cephalosporin antibiotic with a  rapid bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria, including methicillin-susceptible and resistant Staphylococcus aureus (MSSA, MRSA) and susceptible Pseudomonas spp and that is administered intravenously. 

A therapeutic agent in the ABSSSI pipeline that works in a slightly different way is Iclaprim, a novel investigational antibiotic with a targeted Gram-positive spectrum of activity. Motif Bio has completed its investigation in Phase III study for ABSSSI. The drug has received Qualified Infectious Disease Product (QIDP) designation and Fast Track status, and once it gets approved, Iclaprim will be eligible for 10 years of market exclusivity in the US and Europe. However, the road is full of thorns after the USFDA denied approval to the drug in 2018.

Ready to march towards Phase III trials, Brilacidin (PMX-30063) is Innovation Pharmaceuticals’ first in a new class of immunomodulatory antibiotics known as Host Defense Protein (HDP) mimics. It has nabbed QIDP, Fast Track Designation and Priority Review. 

Debiopharm has also successfully completed Phase II investigation of Afabicin (Debio 1450) for Acute bacterial skin and skin structure infections. This drug is a new antibiotic benefiting and has both oral and intravenous formulations.

Contezolid acefosamil (MRX-4) is a novel oxazolidinone, pro-drug of contezolid (MRX-1), and is metabolized in a 2-step process via an intermediate metabolite. MicuRx Pharmaceuticals has finished its Phase II trial for ABSSSI. 

Destiny Pharma, another biotechnology company is involved in the development of their lead therapeutic asset XF-73 (exeporfinium chloride). The company has announced positive interim results of its ongoing Phase IIb study; plans to move forward with the Phase III program this year. Besides, KBP Biosciences is trying its luck with KBP-7072. However, the therapy is still in its early phase I developmental trial and ready for global phase II trial for ABSSSI.

The ABSSSI pipeline, as per DelveInsight, appears quite active with several emerging candidates in Phase III and Phase II stages of development, with many more in the early stages of development. With increasing instances of antibiotic resistance and prevalence of bacterial infections, the ABSSSI market is going to witness much more therapies and pharmaceutical companies foraying into the domain owing to new opportunities available. However, it is not to be missed that the market growth and emerging therapies are in for some serious challenges from already approved therapies, raising antibiotic resistance and recurrence of bacterial infections.